Republic ofthe Philippines Department of Health FDA. FOOD AND DRUG ADMINISTRATION MM, 0.8 JUN 2018 ne BOTS" 204 TO: RAL CONSUMING PUBLIC SUBJECT: Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 10) ‘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: SIVANNA COLORS® LIPSTICK 12H MAKEUP WATERPROOF YOKO SOYBEAN Q10 CREAM BB CREAM FAIRY BLINK NATURAL & NUDE MAKEUP 01: IVORY MEILINDA KISS KISS LIQUID LIPSTICK LOVE ME TENDER (05) HASK® MACADAMIA OIL MOISTURIZING DEEP CONDITIONER BIHAKU WONDER SOAP MILEA BATH & BODY NATURALLY FOR YOU® NATURAL, DEODORANT BLUE 8. LA BELLE NAIL POLISH FRENCH LAVANDER 9. OPTIMA™ COLLAGEN CREAM 10, OPTIMA™ GLUTATHIONE + SOYA SOAP il. GLUTAMAX® PEARL WHITENING MOISTURIZING CREAM 12, TEEN'S INTIMATE COLOR FRAGRANCE POWDER (GREEN AVILON) 13. TEEN'S INTIMATE COLOR FRAGRANCE POWDER (MILK FRESH) 14. TEEN'S INTIMATE COLOR FRAGRANCE POWDER (SIMPLY PINK) 15. UZANA REFRESHING FACIAL WIPES (SANDAL) 16. UZANA REFRESHING FACIAL WIPES (JASMINE) 17. UZANA REFRESHING FACIAL WIPES (ROSE) 18. NEVADA NATURAL PRODUCTS NNP ROSES PRE-MOISTENED TISSUES 19. RXS SKIN RENEWAL TONER #2 20. RXS SKIN RENEWAL CREAM 2 21, RXS BLACK CHARCOAL SOAP. 22. PERFECT PURITY® SKIN BLEMISH BODY WASH WITH SALICYCLIC ACID 23. XTRACARE SIGNATURE® BB BODY LOTION MULTI-ACTION BEAUTIFYING SKIN CARE LIGHT TO MEDIUM SKIN TONES 24, PERSONAL CARE® MOISTURIZING VITAMIN E SKIN CREAM 25. GOREE® WHITENING BODY LOTION VITAMIN E WITH LYCOPENE AVOCADO & ALOEVERA es 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 Civic Drive, Filinvest City, Alabang 1781 Muntinlupa, Philippines Trunk Line +63 2 857 1900 Fax +63 280700751 Website: www. fda.gov.ph Email info@fda.gov.ph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 info@fda.gov.ph. 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 report@fda.gov.ph, 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. NELA CHARADE G/PUNO, RPh Director GeneralANNEX Details of the Unnotified Cosmetic Products PRODUCT NAME PRODUCT DETAILS 1 SIVANNA COLORS® Local Company Responsible for LIPSTICK 128 Placing the Product in the Market: MAKEUP Not Indicated WATERPROOF = Not Indicated Country of Manufacture: Not Indicated 2 YOKO SOYBEAN Q10 Local Company Responsible for CREAM Placing the Product inthe Market: Not Indicated Address Not Indicated Country of Manufacture: ___ Thailand 3. BB CREAM FAIRY Local Company Responsible for BLINK NATURAL & Placing the Product in the Market: NUDE MAKEUP 01: eee aYORY Address: ‘Not Indicated Country of Manufacture Label is in Foreign Language 4 MEILINDA KISS KISS Local Company Responsible for LIQUID LIPSTICK —_ Placing the Product in the Market: LOVE ME TENDER (05) ot Indicated Address: ‘Not Indicated Country of Manufacture: Label isin Foreign Language 3 HASK® MACADAMIA Local Company Responsible for OIL MOISTURIZING Placing the Product in the Market: DEEP CONDITIONER —_ Not Indicated Address, Not Indicated ‘Country of Manufacture: USAPRODUCT NAME. BIHAKU WONDER SOAP PRODUCT DETAILS PRODUCT IMAGE/S Local Company Responsible for = Placing the Product in the Market: ‘Misumi Cosmetics Corporation Address: Rodriguez, Rizal Country of Manufacture: Not Indicated MILEA BATH & BODY NATURALLY FOR YOU® NATURAL DEODORANT BLUE. Local Company Responsible for Placing the Product in the Market Milea Bath & Body Wellness Essentials Address: 2256-B Topacio Street, San Andres Bukid, Manila 1017 Country of Manufacture: Not Indicated LA BELLE NAIL POLISH FRENCH LAVANDER Local Company Responsible for Placing the Product in the Market: Unistar Asia Manufacturing Corp. Address: Valenzuela city Country of Manufacture Not Indicated oprima™ COLLAGEN CREAM OPTIMA™ GLUTATHIONE + SOYA SOAP ‘Local Company Responsible for Placing the Product in the Market Not Indicated Address: Not Indicated Country of Manufacture: Not Indicated Local Company Responsible for Placing the Product in the Market Not Indicated Address: Not Indicated Country of Manufacture: Not Indicatedin “I?” TEEN'S INTIMATE Local Company Responsible for —=*=téiéi 3B PRODUCT NAME GLUTAMAX® PEARL WHITENING MOISTURIZING CREAM ‘TEEN'S INTIMATE COLOR FRAGRANCE POWDER (GREEN AVILON) ‘TEEN'S INTIMATE PRODUCT DET. PRODUCT IMAGES _ Local Company Responsible for. Placing the Product in the Market: Healthwell Nutraceuticals , Inc. : Address: Quezon City , Philippines Country of Manufacture: Not Indicated Local Company Responsible for Placing the Product in the Market Local Company Responsible for IMCL Marketing ats Address: Not Indicated Country of Manufacture: Not Indicated COLOR FRAGRANCE Placing the Product in the Market: POWDER (MILK JMCL Marketing FRESH) See Not Indicated Country of Manufacture: Not Indicated 14 TEEN'SINTIMATE Local Company Responsible for COLOR FRAGRANCE Placing the Product inthe Market: POWDER (SIMPLY IMCL Marketing ey Address: ‘Not Indicated Country of Manufacture: Not Indicated 15 UZANA REFRESHING — Local Company Responsible for FACIAL WIPES Placing the Product in the Market: (SANDAL) Not Indicated Address Not Indicated ‘Country of Manufacture: ‘Not IndicatedPRODUCT NAME PRODUCT DETAILS 16 UZANA REFRESHING Local Company Responsible for FACIAL WIPES Placing the Product in the Market (GASMINE) Bice Indicated, PRODUCT IMAGE/S Address: Not Indicated Country of Manufacture: Not Indicated UZANA REFRESHING — Local Company Responsible for FACIAL WIPES (ROSE) Placing the Product in the Market: Not Indicated Address: Not Indicated Country of Manufacture: Not Indicated NEVADA NATURAL Local Company Responsible for PRODUCTS NNP Pacing the Product in the Market: ROSES PRE- Not Indicated MOISTENED TISSUES . Not Indicated Country of Manufacture: Not Indicated 19 RXSSKIN RENEWAL Local Company Responsible for TONER #2 lacing the Product in the Market: WSC Beauty Products Address: Binondo, Manila Country of Manufacture: Not Indicated 20 RXSSKIN RENEWAL Local Company Responsible for CREAM 2 Placing the Product in the Market: WSC Beauty Products Address: ‘Binondo, Manila Country of Manufacture: Not IndicatedPRODUCT NAME 21 RXS BLACK CHARCOAL SOAP PRODUCT DETAILS Local Company Responsible for Placing the Product in the Market: WSC Beauty Products Address Binondo, Manila Country of Manufacture Not Indicated 22 PERFECT PURITY® SKIN BLEMISH BODY WASH WITH SALICYCLIC ACID Local Company Responsible for Placing the Product in the Market: Not Indicated Address, Not Indicated Country of Manufacture Not Indicated 23 XTRACARE SIGNATURE® BB BODY LOTION MULTI-ACTION BEAUTIFYING SKIN CARE LIGHT TO MEDIUM SKIN TONES Local Company Responsible for Placing the Product in the Market Not Indicated Address: ‘Not Indicated Country of Manufacture: China 24 PERSONAL CARE® MOISTURIZING VITAMIN E SKIN CREAM, 28 GOREE® WHITENING BODY LOTION VITAMIN E WITH LYCOPENE AVOCADO & ALOEVERA. Local Company Responsible for Placing the Product inthe Market: Not Indicated Address: Not Indicated Country of Manufacture: China Local Company Responsible for Placing the Product in the Market: Not Indicated Address Not Indicated Country of Manufacture: Not Indicated