Tretinoin
Topical retinoid. Sold as Retin-A Micro, Renova.
Retin-A Micro
Renova
Each stripe is one section of the label, each division in a stripe one entry in that section.
Tretinoin is the original prescription retinoid, and it holds two separate FDA approvals for two different problems. Retin-A Micro is approved for acne. Renova, the same molecule at a lower strength in a different cream, is approved for fine facial wrinkles, and its label is unusually blunt about what it does not do.
Brands and what each one is approved for
One active ingredient can hold several separate FDA approvals. They are different documents with different approved uses, and mixing them up is the most common mistake made about these medications.
| Brand | Status for this use | Supply | Label version |
|---|---|---|---|
| Retin-A MicroBausch Health US LLC | Approved for skin | Prescription | 1 September 2025 |
| RenovaBausch Health US LLC | Approved for skin | Prescription | 24 February 2026 |
How it works
Tretinoin is a form of vitamin A. The Retin-A Micro label states that the mechanism of action of topical tretinoin in acne is unknown, and that current evidence suggests it reduces the cohesiveness of cells lining the follicle, so fewer of the plugs behind acne lesions form. That hedge is the label's own, and it is worth keeping: the medication is approved on results, not on a settled explanation.
Mechanism of action, Retin-A Micro label
Although tretinoin activates three members of the retinoic acid (RAR) nuclear receptors (RARα, RARβ, and RARγ) which may act to modify gene expression, subsequent protein synthesis, and epithelial cell growth and differentiation, it has not been established whether the clinical effects of tretinoin are mediated through activation of retinoic acid receptors...
What the FDA approved it for
The approved uses, as worded in the label.
Retin-A Micro
- RETIN-A MICRO ® is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.
- RETIN-A MICRO is a retinoid indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.
Renova
- RENOVA (tretinoin cream) 0.02% is indicated as an adjunctive agent (see second bullet point below) for use in the mitigation (palliation) of fine facial wrinkles in patients who use comprehensive skin care and sunlight avoidance programs. RENOVA (tretinoin cream) 0.02% DOES NOT ELIMINATE WRINKLES, REPAIR SUN-DAMAGED SKIN, REVERSE PHOTOAGING, or RESTORE MORE YOUTHFUL or YOUNGER SKIN.
- RENOVA (tretinoin cream) 0.02% has NOT DEMONSTRATED A MITIGATING EFFECT on significant signs of chronic sunlight exposure such as coarse or deep wrinkling, tactile roughness, mottled hyperpigmentation, lentigines, telangiectasia, skin laxity, keratinocytic atypia, melanocytic atypia, or dermal elastosis.
- RENOVA (tretinoin cream) 0.02% should be used under medical supervision as an adjunct to a comprehensive skin care and sunlight avoidance program that includes the use of effective sunscreens (minimum SPF of 15) and protective clothing.
- Patients with visible actinic keratosis and patients with a history of skin cancer were excluded from clinical trials of RENOVA (tretinoin cream) 0.02%. Thus the effectiveness and safety of RENOVA (tretinoin cream) 0.02% in these populations are not known at this time.
- Neither the safety nor the effectiveness of RENOVA (tretinoin cream) 0.02% for the prevention or treatment of actinic keratoses or skin neoplasms has been established.
- Neither the safety nor the efficacy of using RENOVA (tretinoin cream) 0.02% daily for greater than 52 weeks has been established, and daily use beyond 52 weeks has not been systematically and histologically investigated in adequate and well-controlled trials (see WARNINGS).
Forms and strengths
The presentations and strengths listed in the label.
Retin-A Micro
0.1% (1 mg of tretinoin per gram). Gel: 0.04%, 0.06%, 0.08%, and 0.1%
Renova
RENOVA ® (tretinoin cream), 0.02% is supplied in 20 g tube (NDC 0187-5150-20), 40 g tube (NDC 0187-5150-40), 60 g tube (NDC 0187-5150-60), 44 g pump (NDC 0187-5150-44).
How the label says it is taken
What the label states about administration. It is not a dosing instruction for any individual.
Retin-A Micro
- For topical use only. Not for oral, ophthalmic, or intravaginal use.
- Keep away from eyes, mouth, paranasal creases of the nose, and mucous membranes.
- Apply a thin layer of RETIN-A MICRO to skin where acne lesions appear (cover the entire affected area) (0.04%, 0.06%, 0.08%, or 0.1%) once daily in the evening.
Renova
- Do NOT use RENOVA (tretinoin cream) 0.02% if the patient is pregnant or is attempting to become pregnant or is at high risk of pregnancy.
- Do NOT use RENOVA (tretinoin cream) 0.02% if the patient is sunburned or if the patient has eczema or other chronic skin conditions of the face.
- Do NOT use RENOVA (tretinoin cream) 0.02% if the patient is inherently sensitive to sunlight.
- Do NOT use RENOVA (tretinoin cream) 0.02% if the patient is also taking drug(s) known to be photosensitizers (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of augmented phototoxicity. Patients require detailed instruction to obtain maximal benefits and to understand all the precautions necessary to use this product with greatest safety.
Most common adverse reactions
The adverse reactions the label reports as most common.
Retin-A Micro
Most common adverse reactions were skin irritation, skin burning, erythema, peeling, dryness, itching, and dermatitis.
Renova
(See WARNINGS and PRECAUTIONS.) In double-blind, vehicle-controlled studies involving 339 patients who applied RENOVA (tretinoin cream) 0.02% to their faces, adverse reactions associated with the use of RENOVA (tretinoin cream) 0.02% were limited primarily to the skin. Almost all patients reported one or more local reactions such as peeling, dry skin, burning, stinging, erythema, and pruritus.
Warnings and precautions
The warnings and precautions section of the label.
Retin-A Micro
- Local Skin Irritation: RETIN-A MICRO can cause local skin irritation, including excessive dryness, redness, swelling, peeling, itching, blistering, burning, or stinging
- Initial Worsening of Inflammatory Acne Vulgaris: During the early weeks of RETIN-A MICRO treatment, an apparent exacerbation of inflammatory lesions may occur. If RETIN-A MICRO is tolerated, this should not be considered a reason to discontinue therapy.
- Photosensitivity: RETIN-A MICRO can cause photosensitivity. Advise patients to avoid or minimize unnecessary exposure to UV light, including sunlight and sunlamps. Advise patients to use sunscreen (SPF ≥15) and sun-protective clothing if UV light exposure cannot be avoided. Avoid use on sunburn skin.
Renova
- RENOVA (tretinoin cream) 0.02% is a dermal irritant, and the results of continued irritation of the skin for greater than 52 weeks in chronic use with RENOVA (tretinoin cream) 0.02% are not known. There is evidence of atypical changes in melanocytes and keratinocytes and of increased dermal elastosis in some patients treated with RENOVA (tretinoin cream) 0.05% for longer than 48 weeks.
- RENOVA (tretinoin cream) 0.02% should not be administered if the patient is also taking drugs known to be photosensitizers (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of augmented phototoxicity.
Contraindications
Situations in which the label states the medication must not be used.
Retin-A Micro
None. The label states that there are no contraindications.
Renova
- This drug is contraindicated in individuals with a history of sensitivity reactions to any of its components.
- It should be discontinued if hypersensitivity to any of its ingredients is noted.
Drug interactions
Interactions the label singles out.
Renova
- Concomitant topical medications, medicated or abrasive soaps, shampoos, cleansers, cosmetics with a strong drying effect, products with high concentrations of alcohol, astringents, spices or lime, permanent wave solutions, electrolysis, hair depilatories or waxes, and products that may irritate the skin should be used with caution in patients being treated with RENOVA (tretinoin cream) 0.02%...
- RENOVA (tretinoin cream) 0.02% should not be administered if the patient is also taking drugs known to be photosensitizers (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of augmented phototoxicity.
Pregnancy and breastfeeding
The opening of the pregnancy section of the label. The full section is longer and is in the source document.
Retin-A Micro
Available data from published prospective observational studies and retrospective cohort studies over decades of use of topical tretinoin in pregnant women have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data).
Renova
Teratogenic Effects ORAL tretinoin has been shown to be teratogenic in rats, mice, rabbits, hamsters, and subhuman primates. It was teratogenic and fetotoxic in Wistar rats when given orally or topically in doses greater than 1 mg/kg/day (42 times the maximum human systemic dose normalized for total body surface area). However, variations in teratogenic doses among various strains of rats have been reported.
Generic or brand
Generic tretinoin cream and gel are approved and widely available. The branded versions differ mainly in the vehicle the tretinoin is delivered in, which the labels describe in detail.
The FDA label database lists 27 approved generic applications for this ingredient.
What affects the cost
Tretinoin has been generic for decades, and the cost difference between a generic tube and a branded delivery system is one of the larger gaps in this category. This site does not track prices beyond the acquisition data below and does not link to sellers.
What pharmacies pay for it
These are acquisition costs: what pharmacies in the United States pay on average to buy the medication, published weekly by the Centers for Medicare and Medicaid Services. They are not retail prices and not what a person pays at the counter, which depends on insurance, pharmacy and discount programmes. They are useful as an objective floor and for seeing how far a brand sits above its generic.
| Measured | Generic |
|---|---|
| per gram | $1.02 (range $0.476 to $10.59, 1512 listings) |
Median of 1512 listings. Effective dates 2025-12-17 to 2026-07-22, file dated 2026-07-29.
Compared with other medications
What the labels do not do is compare one medication against another. These pages put two of them side by side.
Common questions
- Does the FDA label say tretinoin reverses ageing?
- The opposite. The Renova label states in capital letters that it does not eliminate wrinkles, repair sun-damaged skin, reverse photoaging or restore younger skin. What it is approved for is the mitigation of fine facial wrinkles, in people who also use a comprehensive skin care and sun avoidance programme. That qualification is part of the approved indication, not a footnote.
- Is Retin-A the same as Renova?
- Both are tretinoin, but they are separate approvals with separate labels, different strengths and different approved uses. Retin-A Micro covers acne. Renova covers fine facial wrinkles. This page links to both documents.
- What does the label say about pregnancy?
- The Renova label instructs that it not be used by someone who is pregnant, attempting to become pregnant, or at high risk of pregnancy. The full pregnancy section of each label is linked from this page.
Other medications under skin
Whether each one carries an FDA approval for this use is marked on its page and in this list.
Sources
Every fact above comes from one of these documents. The date is the effective date of the label version this page was built from.
FDA prescribing information for Retin-A Micro
Bausch Health US LLC. Label version 23, effective 1 September 2025.
FDA prescribing information for Renova
Bausch Health US LLC. Label version 14, effective 24 February 2026.
Page last updated: 5 August 2026
Compiled by the HealthyStudy editorial team from FDA source documents. No medical reviewer is credited on this page, because none reviewed it.