FDA Advisory No. 2018-226 Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 12)

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The Food and Drug Administration (FDA) advises the public against the purchase and use of the following unnotified cosmetic products whose particulars/details are provided in the attached annex:

  1. MAC GIAMBATTISTA VALLI PARIS MATTE LIPSTICK – KINDA SEXY
  2. HUDABEAUTY MATTE LIPSTICK 104 MATERIAL GIRL
  3. HUDABEAUTY MATTE LIPSTICK CHEERLEADER
  4. NEUTROGENA® PORE REFINING® EXFOLIATING CLEANSER
  5. NEUTROGENA® HYDRO BOOST HYDRATING CLEANSING GEL
  6. NEUTROGENA® TRIPLE MOISTURE® SILK TOUCH LEAVE-IN CREAM WITH UV SHIELD
  7. DONG BANG® BABY TENDER BABY WIPES (FRESH SCENTED-PINK)
  8. JOHNSON’S® CLEANSING FACIAL WIPES 3IN1
  9. AMPAL’S COSMECEUTICAL
  10. NÀ TING® WHITE CLEANSER
  11. JERKYS INSTANT HAND SANITIZER
  12. SAISI PERMANENT HAIR COLORANT WITH ACTIVE VEGETABLE INGREDIENTS (H-20 DIANA GOLDEN)
  13. AICHUN BEAUTY® SLIMMING AND DETOXIFYING SOAP GREEN TEA ESSENCE
  14. NICE PONPON BEAUTY PERFUMED SOAP
  15. AS ASHLEY SHINE 2IN1 MAKEUP BASE + FOUNDATION CREAM 2 (NO. AS804)
  16. AS ASHLEY SHINE 3IN1 B.B CREAM SUN DAMAGED CONTROL CREAM HIGH PROTECTION SPF 50 (NO. AS9007-1)
  17. JIGOTT ALOE SUN PROTECT BB CREAM SPF 41 PA+++
  18. SUNSTAR STRIPE PASTE
  19. KAO (LABEL IS IN FOREIGN LANGUAGE)
  20. MARI & U DOT VITA MASK WHITENING TONE UP
  21. UNI KERATIN MOROCCO ARGAN OIL HAIR REBORN TREATMENT VITAMIN E INTENSIVE REPAIR FOR SMOOTH AND STRAIGHT HAIR
  22. FRESHMAN MASCULINE WASH TEA TREE OIL
  23. PINK BLUSH SKIN ESSENTIALS BEAUMAX TONER
  24. PINK BLUSH SKIN ESSENTIALS ACNE SOAP
  25. PINK BLUSH SKIN ESSENTIALS KOJIC ACID SOAP
  26. RED SEAL® BAKING SODA TOTAL MOUTH FRESHNESS
  27. PINK BLUSH SKIN ESSENTIALS BY AMBER & PINK SUNBLOCK PINK CREAM SPF 30
  28. EB EVERA MAGIC LIPSTICK WITH VITAMIN E – ORANGE
  29. AMORE PARFUM INSPIRED PERFUMES
  30. HANZHIXIU® PERMANENT HAIR COLORANT WITH ACTIVE VEGETABLE INGREDIENTS (A-16 COFFEE)
  31. HANZHIXIU® PERMANENT HAIR COLORANT WITH ACTIVE VEGETABLE INGREDIENTS (A-21 DARK COFFEE)
  32. HANZHIXIU® PERMANENT HAIR COLORANT WITH ACTIVE VEGETABLE INGREDIENTS (A-3 BURGUNDY RED)
  33. EON SKIN CARE EON REFRESH PREMIUM BOTOX GEL
  34. EDMARK® SPLINA CHLOROPHYLL SOAP
  35. LUMINE TURMERIC + LEMON SOAP SKIN LIGHTENING AND ANTI-ACNE HERBAL BATH SOAP
  36. GEVEMIA TRI & 1™ PROFESSIONAL HAIR COLOUR NATURAL & EASY (H817 DIANA GOLDEN)
  37. GEVEMIA TRI & 1™ PROFESSIONAL HAIR COLOUR NATURAL & EASY (H823 PURPLISH RED)
  38. GEVEMIA TRI & 1™ PROFESSIONAL HAIR COLOUR NATURAL & EASY (H829 COFFEE PURPLE)
  39. GELCO HAND SANITIZER WITH VITAMIN E GREEN APPLE
  40. DERMCARE FRESH FEMININE WASH FRESHLY COOL
  41. THE FACE SHOP REAL NATURE AVOCADO FACE MASK
  42. BEAUTY WISE REJUVENATING TONER
  43. BEAUTY WISE KOJIC ACID SOAP WITH BEARBERRY EXTRACT
  44. DROPLETS OF NATURE. REJUVENATING LIFT & CORRECT KIT:
    1. DROPLETS OF NATURE. REJUVENATING LIFT & CORRECT SUNBLOCK CREAM WITH SPF
    2. DROPLETS OF NATURE. REJUVENATING LIFT & CORRECT KOJIC ACID SOAP
    3. DROPLETS OF NATURE. REJUVENATING LIFT & CORRECT REJUVENATING TONER
    4. DROPLETS OF NATURE. REJUVENATING LIFT & CORRECT REJUVENATING CREAM
  1. LOVIA PROFESSIONAL HENNA HERBAL BASED HAIR COLOUR POWDER NATURAL BLACK
  2. GARNIER SKIN NATURALS LIGHT COMPLETE WHITE SPEED™ 12 H SHINE – FREE WHITENING SERUM CREAM
  3. MOIST SKIN CARE NATURAL EXTRACT APPLE REFRESHING MASK SHEET
  4. MIR & RYVI BANANA SOAP SPOT LIGHTENING BEAUTY BAR

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned cosmetic products have not gone through the verification process of the agency and have not been issued the proper authorization in the form of acknowledged cosmetic notifications. Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization from FDA is prohibited.

Accordingly, because unnotified cosmetic products have not gone through the verification process of the FDA, the agency cannot guarantee their quality and safety. The use of such violative products may pose potential health hazards to the consuming public.

Potential hazards may come from ingredients that are not allowed to be part of a cosmetic product or from the contamination of heavy metals such as mercury especially in whitening cosmetic products. The use of substandard and possibly adulterated cosmetic products may result to adverse reactions including but not limited to skin irritation, itchiness, anaphylactic shock and organ failure.

In light of the above, the public is advised not to purchase the aforementioned violative products. Moreover, the public is also advised to be vigilant against cosmetic products that might not be duly notified with FDA. Always check if a cosmetic product has been notified with FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph.

All concerned establishments are warned not to distribute the above-identified violative cosmetic products until they have already been covered by the appropriate authorization (cosmetic notification), otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of the above unnotified cosmetic products, utilize our online reporting facility, eReport, at www.fda.gov.ph/ereport, or e-mail us via [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 857-1900 local 8113 or 8107.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2018-226