Label: ADVANCED FORMULA LIP BALM SPF 25- avobenzone, octinoxate cream
- NDC Code(s): 80949-001-07
- Packager: Anthony Skin LLC
- 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 April 3, 2023
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- Active Ingredients:
- Purpose
- Uses:
- Directions:
- Other Information:
- Warnings:
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Inactive Ingredients:
Petrolatum, Cera Alba (Beeswax), Butyrospermum Parkii (Shea Butter), Persea Gratissima (Avocado) Oil, Flavor (Aroma), Resveratrol, Camellia Sinensis (White Tea) Leaf Extract, Camellia Sinensis (Green Tea) Leaf Extract, Tocopheryl Acetate, Carthamus Tinctorius (Safflower) Seed Oil, Stevia Rebaudiana Leaf Extract, Titanium Dioxide (CI 77891), Limonene.
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INGREDIENTS AND APPEARANCE
ADVANCED FORMULA LIP BALM SPF 25
avobenzone, octinoxate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80949-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 g Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) YELLOW WAX (UNII: 2ZA36H0S2V) SHEA BUTTER (UNII: K49155WL9Y) AVOCADO OIL (UNII: 6VNO72PFC1) SAFFLOWER OIL (UNII: 65UEH262IS) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) RESVERATROL (UNII: Q369O8926L) WHITE TEA (UNII: O0M3396E09) GREEN TEA LEAF (UNII: W2ZU1RY8B0) LIMONENE, (+)- (UNII: GFD7C86Q1W) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80949-001-07 7 g in 1 TUBE; Type 0: Not a Combination Product 01/05/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/05/2020 Labeler - Anthony Skin LLC (117392467) Establishment Name Address ID/FEI Business Operations Fragrance Manufacturing, Inc. 793406000 MANUFACTURE(80949-001)