Label: LIP CARE SPF 15 WITH VITAMIN E- octinoxate, oxybenzone stick
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Contains inactivated NDC Code(s)
NDC Code(s): 51514-0336-1 - Packager: Autumn Harp, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 30, 2014
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- Active Ingredient
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Inactive Ingredients:
Ricinus Communis (Castor) Seed Oil, Hydrogenated Coconut Oil, Olea Europaea (Olive) Fruit Oil, Beeswax, Euphorbia Cerifera (Candelilla) Wax, Cocos Nucifera (Coconut) Oil, Tocopheryl Acetate, Vanilla Planifolia Extract,Ammonium Glycyrrhizate, Calendula Officinalis Flower Extract, Echinacea Purpurea Extract, Tocopherol, Glycine Soja (Soybean) Oil.
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INGREDIENTS AND APPEARANCE
LIP CARE SPF 15 WITH VITAMIN E
octinoxate, oxybenzone stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51514-0336 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 5.0 g in 100 g Inactive Ingredients Ingredient Name Strength CASTOR OIL (UNII: D5340Y2I9G) COCONUT OIL (UNII: Q9L0O73W7L) OLIVE OIL (UNII: 6UYK2W1W1E) YELLOW WAX (UNII: 2ZA36H0S2V) CANDELILLA WAX (UNII: WL0328HX19) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C) VANILLA (UNII: Q74T35078H) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) ECHINACEA PURPUREA (UNII: QI7G114Y98) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) Product Characteristics Color Score Shape Size Flavor VANILLA Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51514-0336-1 4.2 g in 1 PACKAGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 08/20/2004 Labeler - Autumn Harp, Inc. (064187883) Establishment Name Address ID/FEI Business Operations Autumn Harp, Inc. 064187883 manufacture(51514-0336)