Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y), DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)
Tri-Coastal Design Company Inc.
OCTINOXATE
OCTINOXATE 6 g in 100 g
TOPICAL
OTC DRUG
Sunscreen Skin Protectant - Helps prevent sunburn - Temporarily protects and relieves chapped lips
OTC monograph final
LIP BALM - OCTINOXATE OXYBENZONE DIMETHICONE LIPSTICK TRI-COASTAL DESIGN COMPANY INC. _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 INGREDIENT Octyl Methoxycinnamate 6% Oxybenzone 6% Dimethicone 1% PURPOS E Sunscreen Skin Protectant US ES Helps prevent sunburn Temporarily protects and relieves chapped lips WARNINGS Keep out of eyes. Stop use if rash or irritation occurs. Keep out of reach of children. For external use only. DIRECTIONS Apply liberally before sun exposure and as needed. INACTIVE INGREDIENTS BHA, BHT, Caprylic/Capric Triglyceride, Cera Microcristallina, Flavor, Lanolin, Mineral Oil (Paraffinum Liquidum), Ozokerite, Petrolatum, Phenyl Trimethicone, Polyethylene, Propylparaben, PVP/Eicosene Copolymer, Tocopheryl Acetate PACKAGE LABEL Package Label LIP BALM octinoxate oxybenzone dimethicone lipstick PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:49 8 52-20 2 ROUTE OF ADMINISTRATION TOPICAL Tri-Coastal Design Company Inc. ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 6 g in 10 0 g O XYBENZO NE (UNII: 9 5OOS7VE0 Y) (OXYBENZONE - UNII:9 5OOS7VE0 Y) OXYBENZONE 6 g in 10 0 g DIMETHICO NE (UNII: 9 2RU3N3Y1O) (DIMETHICONE - UNII:9 2RU3N3Y1O) DIMETHICONE 6 g in 10 0 g INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH BUTYLATED HYDRO XYANISO LE (UNII: REK49 6 0 K2U) BUTYLATED HYDRO XYTO LUENE (UNII: 1P9 D0 Z171K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9 H2L21V7U) LANO LIN (UNII: 7EV6 5EAW6 H) MINERAL O IL (UNII: T5L8 T28 FGP) PETRO LATUM (UNII: 4T6 H12BN9 U) PHENYL TRIMETHICO NE (UNII: DR0 K5NOJ4R) PRO PYLPARABEN (UNII: Z8 IX2SC1OH) PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:49 8 52-20 2-0 5 5 in 1 BOX 1 NDC:49 8 52-20 2-35 3.5 g in 1 TUBE MARKETING INFOR Perskaitykite visą dokumentą