Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
Octinoxate 7.5%, Titanium dioxide 5.6%
Laboratoires Industriels de Vichy (LIDV)
TOPICAL
OTC DRUG
Uses - helps prevent sunburn - higher SPF gives more sunburn protection - protects against UVA/UVB rays Directions - apply evenly before sun exposure and as needed - children under 6 months of age: ask a doctor
OTC monograph not final
LA ROCHE-POSAY LABORATOIRE PHARMACETIQUE HYDRAPHASE UV EYES HYDRATING PROTECTIVE CREAM SPF 29- OCTINOXATE TITANIUM DIOXIDE LOTION LABORATOIRES INDUSTRIELS DE VICHY (LIDV) _Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they_ _comply with applicable regulations and policies. FDA has not evaluated whether this product complies._ ---------- DRUG FACTS ACTIVE INGREDIENTS Octinoxate 7.5% Titanium dioxide 5.6% USES DIRECTIONS US ES helps prevent sunburn higher SPF gives more sunburn protection protects against UVA/UVB rays DIRECTIONS apply evenly before sun exposure and as needed children under 6 months of age: ask a doctor WARNINGS WARNINGS FOR EXTERNAL USE ONLY WHEN USING THIS PRODUCT keep out of eyes. Rinse with water to remove. STOP USE AND ASK A DOCTOR IF rash or irritation develops and lasts KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away. LA ROCHE-POSAY LABORATOIRE PHARMACETIQUE HYDRAPHASE UV EYES HYDRATING PROTECTIVE CREAM SPF 29 octinoxate titanium dioxide lotion PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:6 6 38 2-157 Laboratoires Industriels de Vichy (LIDV) ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH O CTINO XA TE (UNII: 4Y5P7MUD51) (Octino xate - UNII:4Y5P7MUD51) O c tino xa te 1.125 mL in 15 mL TITA NIUM DIO XIDE (UNII: 15FIX9 V2JP) (Titanium dio xide - UNII:15FIX9 V2JP) Titanium dio xide 1.14 mL in 15 mL PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:6 6 38 2-157-0 1 1 in 1 CARTON 1 15 mL in 1 TUBE MARKETING INFORMATION MARKE TING CATE GORY APPLICATION NUMBE R OR MONOGRAPH CITATION MARKE TING START DATE MARKE TING END DATE OTC mo no graph no t final pa rt352 0 9 /0 1/20 0 9 LABELER - Laboratoires Industriels de Vichy (LIDV) (282658798) ESTABLISHMENT NAME AD D RE S S ID/FEI BUSINE SS OPE RATIONS Labo rato ires Industriels de Vichy (LIDV) 28 26 58 79 8 ma nufa c tu Прочитайте повний документ