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beautydew

Evidence library

FDA drug labels & guidance

US Food & Drug Administration drug labels (DailyMed) and cosmetic-ingredient guidance.

48 sources · page 1 of 1

  1. "Hypoallergenic" Cosmetics ↗
  2. "Organic" Cosmetics ↗
  3. Adapalene 0.1% OTC Drug Facts ("may appear to worsen"; irritation lessens after 4wk). DailyMed ↗
  4. Allergens in Cosmetics ↗
  5. Alpha Hydroxy Acids — cosmetic ingredient page (18% UV-sensitivity increase; ~1 week persistence). FDA ↗
  6. AZELEX (azelaic acid cream) 20% — FDA prescribing information ↗
  7. AZELEX 20% (azelaic acid) FDA label ("improvement...within four weeks"). DailyMed ↗
  8. Cosmetic Ingredient Names and ingredient labeling ↗
  9. Cosmetics Labeling Claims ↗
  10. Cosmetics Labeling Guide — declaration and order of ingredients ↗
  11. Cosmetics Safety Q&A: Shelf Life ↗
  12. Differin (adapalene) Gel 0.3% FDA label (12wk trial). DailyMed ↗
  13. DIFFERIN (adapalene) Gel, 0.3% — Full Prescribing Information ↗
  14. Drug Approval Package: Anthelios SX (Avobenzone, Ecamsule & Octocrylene), NDA #021502 — ecamsule reached the US market in 2006 only via a product-specific New Drug Application, not the general OTC monograph. U.S. FDA ↗
  15. FDA Fact Sheet: FDA Proposed Rule — Sunscreen Drug Products for Over-the-Counter Human Use ↗
  16. FDA Final Administrative Order OTC000008-1: PABA and trolamine salicylate; scheduled effective date September 11, 2027 ↗
  17. FDA Final Administrative Order OTC000039: bemotrizinol, up to 6%, with formulation conditions; effective August 9, 2026 ↗
  18. FDA Guidance for Industry: Labeling for Cosmetics Containing Alpha Hydroxy Acids ↗
  19. FDA Proposes Expanding Sunscreen Active Ingredient List (bemotrizinol proposed order, December 2025) ↗
  20. FDA warns consumers about skin products containing mercury — repeated skin use lets mercury absorb into the bloodstream, causing kidney and neurological damage. U.S. FDA ↗
  21. FINACEA (azelaic acid) Gel, 15% — FDA prescribing information ↗
  22. FINACEA 15% (azelaic acid) FDA label (rosacea, 12wk RCTs). DailyMed ↗
  23. Fragrances in Cosmetics ↗
  24. Frequently Asked Questions on Soap ↗
  25. Hydroquinone 4% cream label ("if no improvement after 2 months...discontinue"). DailyMed ↗
  26. Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?) ↗
  27. Limited number of voluntary recalls initiated after FDA testing of acne products for benzene; findings show a small number of products with elevated levels of benzene contamination ↗
  28. Mercury poisoning linked to skin products — label words that mean mercury: 'mercurous chloride', 'calomel', 'mercuric', 'mercurio', 'mercury'; mercury passes into breast milk, so nursing infants are especially vulnerable. U.S. FDA Consumer Update ↗
  29. Microbiological Safety and Cosmetics ↗
  30. Minoxidil topical solution drug label (Warnings) — 'may be harmful if used when pregnant or breast-feeding'. DailyMed, U.S. NLM ↗
  31. Over-the-Counter (OTC) Monograph M019: Antiperspirant Drug Products for Over-the-Counter Human Use ↗
  32. Questions and Answers: FDA posts deemed final order and proposed order for over-the-counter sunscreen ↗
  33. RENOVA (tretinoin 0.02%) FDA label ("3 to 4 months"; "up to 6 months"). DailyMed ↗
  34. RENOVA (tretinoin cream) FDA label (use depilatories/waxes with caution). DailyMed ↗
  35. RETIN-A MICRO (tretinoin gel) FDA label — irritation and apparent worsening peak in the first weeks ↗
  36. Safely Soothing Teething Pain in Infants and Children — benzocaine can cause methemoglobinemia; do not use benzocaine products in children under 2, and viscous lidocaine is not for teething. U.S. FDA ↗
  37. Shelf Life and Expiration Dating of Cosmetics ↗
  38. Small Businesses & Homemade Cosmetics: Fact Sheet ↗
  39. Summary of Cosmetics Labeling Requirements ↗
  40. Sunscreen: How to Help Protect Your Skin from the Sun ↗
  41. Talc — FDA's ongoing asbestos-in-talc testing program (asbestos found in some tested cosmetic talc). U.S. FDA Cosmetic Ingredients ↗
  42. Testing for Biotin Interference in In Vitro Diagnostic Devices — Guidance for Industry ↗
  43. Tips to Stay Safe in the Sun: From Sunscreen to Sunglasses ↗
  44. Tranexamic Acid Tablets — Prescribing Information ↗
  45. Tretinoin gel FDA label (caution with salicylic acid / abrasive, drying products). DailyMed ↗
  46. Tretinoin gel label ("clean and dry skin"). DailyMed ↗
  47. Tretinoin Gel prescribing information (FDA-approved label) ↗
  48. TWYNEO (tretinoin 0.1%/benzoyl peroxide 3%) FDA label. DailyMed ↗
FDA drug labels & guidance sources — beautydew labs