FDA Advisory No. 2019-051 || Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 2)

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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. DEXE® HAIR COLOR SPRAY (COFFEE)
  2. DEXE® HAIR COLOR SPRAY (YELLOW)
  3. TANAKO CC CREAM ALOE VERA REFRESHING (01)
  4. TANAKO BABY SKIN BLEMISH COVER CONCEALER (NO.128, 001)
  5. HELLO KITTY L-GLUTATHIONE MOIST WHITENING LOTION SPF 70+++ (CHANEL)
  1. GLUTATHIONE W/ TAWAS
  2. TAWAS WITH MORINGA SOAP 2 IN 1
  3. MG GLUTA TAWAS SCENTED WITH CALAMANSI OIL
  4. NEW GLUTA CALAMANSI THE ORIGINAL
  5. NEW GLUTA CALAMANSI WITH BAKING SODA
  6. ANTI-AGEING W/ APPLE STEMCELL
  7. ORANGE PEEL
  8. KOJIC W/ BLEACH
  9. GLUTA W/ LAVENDER
  10. OVERLOAD
  11. LG CARE (LABEL IS IN FOREIGN LANGUAGE)
  12. FOOT™, FOOT POWDER
  13. TIANNUO® SMOOTH SHINE MOISTURIZING BB CREAM (520)
  14. HANBEILI NON-TRACE CONCEALER (01)
  15. COLOUR DIARY PLANTS FRUITS
  16. MINGHAN COSMETIC LIPSTICK DEEP SEA FISH OIL NONSTICK CUP (04)
  1. RUORI LIANA PROFESSIONAL MAKEUP NUDE MOIST LIPSTICK (04)
  2. LIPSTICK CUICU
  3. MIDIO MINUENESS LINE EYELINER
  4. MIDIO SKIN REJUVENATING ROSE HAND CREAM
  5. COSMETIC BUFFET STRETCHMARK SOAP
  6. DERMACOL MIRACELE SHES EMBELISH PERFECT BB CREAM WATERPROOF SPF 30
  7. ANASTASIA BEVERLY HILLS® DIPBROW™ POMADE MEDIUM BROWN
  1. ANASTASIA BEVERLY HILLS® MASCARA ROUGEALEVRES LIQUIDE
  2. COSMETIC BUFFET BLEACHING LOTION SUNBLOCK SPF 15
  3. COSMETIC BUFFET BODY SCRUB
  4. PNF PEINFEN® SAEMMUL REAL TINT THE RABBIT DYE LIQUID LIP (03)
  5. LI’L TOTS BABY WIPES
  6. ZAFIRAH ALLELE WHITE 5 IN 1 INSTANT WHITE BODY LOTION SPF 35
  7. FRESHMAN WHITENING BAR WITH 8 POWERFUL WHITENING INGREDIENTS
  8. BENCH/® FIX PROFESSIONAL ROCK & RULE MATTE SCULPTING WAX
  9. ALL WHITE® PLACENTA HERBAL LIGHTENING SOAP CLASSIC
  10. PURESOFT KIDDIE WIPES (BUBBLEGUM SCENT)
  11. BURT’S BEES® NATURAL FACE ESSENTIALS PINK GRAPEFRUIT FACIAL CLEANSING TOWELETTES
  12. YADAH BE MY TINT (01 WANNABE PINK)
  13. YSA BOTANICA GREEN PAPAYA ACNE SOAP WITH WHITENING FORMULA FOR PIMPLE TREATMENT
  14. ERASE PLANTCENTA 3-IN-1 MAGIC SOAP WITH SHEA BUTTER
  15. D & J CASTOR OIL
  16. HELLO GORGEOUS PURIFYING SOAP
  17. HELLO GORGEOUS OF SHEET! FRESH MERMAID ANTI-ACNE FACIAL MASK
  18. BARBIE™ MY BEAUTY KIT BARBIE LIQUID SOAP
  19. SKINFOOD SINCE 1957 SHEA BUTTER PERFUMED HAND CREAM ROSE SCENT
  20. SKINFOOD SINCE 1957 TOMATO COOL JELLY TINT
  21. ERASE® WHITENING DEODORANT WITH HAIR RETARDANT AND ANTIPERSPIRANT
  22. ERASE® SUNBLOCK CREAM WITH MOISTURIZER SPF 40
  23. ERASE® BLACKOUT SUNBLOCK LOTION SPF 60
  24. ERASE® ORGANICS WHITENING SERUM
  25. GLUTA® BY ERASE WHITENING FACIAL CLEANSER WITH OIL CONTROL
  26. GLUTA® BY ERASE WHITENING FACIAL CLEANSER WITH KOREAN GINSENG AND TAWAS
  27. GLUTA® BY ERASE WHITENING LOTION WITH KOREAN GINSENG AND VITAMIN E
  28. GLUTA® BY ERASE WHITENING LOTION WITH KOJIC ACID & MORINGA EXTRACT

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. 2019-051