Label: YES TO CARROTS SWEET FIG LIP BUTTER WITH SPF 15- zinc oxide stick
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Contains inactivated NDC Code(s)
NDC Code(s): 51514-0320-1 - 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 October 2, 2013
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- Active Ingredient
- Purpose
- Uses
- Warnings:
- Directions
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Sun Protection Measures
Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10am - 2pm. Wear long sleeved shirts, pants, hats and sun-glasses.
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Inactive Ingredients
Inactive Ingredients: Beeswax, Cocos Nucifera (Coconut) Oil, Olea Europaea (Olive) Fruit Oil, Helianthus Annus (Sunflower) Seed Oil, Flavor, Copernicia Cerifera (Carnauba) Wax, Jojoba Esters, Butyrospermum Parkii (Shea) Butter*, Ammonium Glycyrrhizate, Tocopherol, Ficus Carica (Fig) Extract, Limonene. * Certified Organic Ingredient
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INGREDIENTS AND APPEARANCE
YES TO CARROTS SWEET FIG LIP BUTTER WITH SPF 15
zinc oxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51514-0320 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 7.6 g in 100 g Inactive Ingredients Ingredient Name Strength COCONUT OIL (UNII: Q9L0O73W7L) OLIVE OIL (UNII: 6UYK2W1W1E) YELLOW WAX (UNII: 2ZA36H0S2V) CARNAUBA WAX (UNII: R12CBM0EIZ) JOJOBA OIL (UNII: 724GKU717M) SUNFLOWER OIL (UNII: 3W1JG795YI) FIG (UNII: TGD87RII2U) SHEA BUTTER (UNII: K49155WL9Y) TOCOPHEROL (UNII: R0ZB2556P8) AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C) FICUS CARICA LEAF (UNII: 59K6U5G4K7) SOYBEAN OIL (UNII: 241ATL177A) LINALOOL, (+/-)- (UNII: D81QY6I88E) BENZYL ALCOHOL (UNII: LKG8494WBH) LIMONENE, (+/-)- (UNII: 9MC3I34447) CITRAL (UNII: T7EU0O9VPP) EUGENOL (UNII: 3T8H1794QW) GERANIOL (UNII: L837108USY) Product Characteristics Color Score Shape Size Flavor FIG Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51514-0320-1 4.25 g in 1 CONTAINER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 02/01/2013 Labeler - Autumn Harp, Inc (064187883) Establishment Name Address ID/FEI Business Operations Autumn Harp, Inc 064187883 manufacture(51514-0320)