Label: SUNSCREEN- octinoxate, oxybenzone lipstick
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Contains inactivated NDC Code(s)
NDC Code(s): 19392-300-01 - Packager: Humphreyline
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated January 1, 2020
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SUNSCREEN
octinoxate, oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:19392-300 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 40 mg in 1 g Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) ETHYLHEXYL PALMITATE (UNII: 2865993309) YELLOW WAX (UNII: 2ZA36H0S2V) PARAFFIN (UNII: I9O0E3H2ZE) MINERAL OIL (UNII: T5L8T28FGP) CERESIN (UNII: Q1LS2UJO3A) CETYL ALCOHOL (UNII: 936JST6JCN) ALOE VERA LEAF (UNII: ZY81Z83H0X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PROPYLPARABEN (UNII: Z8IX2SC1OH) Product Characteristics Color Score Shape Size Flavor TROPICAL FRUIT PUNCH (tropical flavor) , SPEARMINT (spearmint flavor) , BUBBLE GUM (bubble gum flavor) , VANILLA (vanilla flavor) , CHERRY (cherry flavor) , STRAWBERRY (strawberry flavor) , BERRY (berry flavor) , WATERMELON (watermelon flavor) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:19392-300-01 4 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/08/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/01/2010 Labeler - Humphreyline (122539042)