Label: DAILY PROTECTING SPF15 SUNSCREEN- lotion lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 51514-0352-1 - 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 July 12, 2016
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- Drug Facts
- Active Ingredient
- Purpose
- Uses:
- Warnings:
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Directions:
For full protection, apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m. - 2 p.m. Wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months: Ask a doctor.
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Inactive Ingredients:
Water, Coco caprylate, Cocos Nucifera (Coconut) Oil, Sorbitan Stearate, Glycerin, Niacinamide, Magnesium Aluminum Silicate, Sucrose Cocoate, Phenoxyethanol, Xanthan Gum, Gluconolactone, Tripeptide 29, Laminaria Digitata Powder, Tocopherol, Lecithin, Codium Fragile Extract, Fragrance, Flavor, Linalool, Porphyridium Cruentum Exsuded Culture Medium, Leuconostoc Radish Root Ferment Filtrate, Citral, Geraniol, Bladderwrack Powder, Sodium Benzoate, Citric Acid, Potassium Sorbate, Citronellol
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INGREDIENTS AND APPEARANCE
DAILY PROTECTING SPF15 SUNSCREEN
lotion lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51514-0352 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 10 g in 100 g Inactive Ingredients Ingredient Name Strength LIMONENE, (+)- (UNII: GFD7C86Q1W) PORPHYRIDIUM PURPUREUM (UNII: K2P8K2558N) LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458) CITRAL (UNII: T7EU0O9VPP) GERANIOL (UNII: L837108USY) FUCUS VESICULOSUS (UNII: 535G2ABX9M) SODIUM BENZOATE (UNII: OJ245FE5EU) ISOEUGENOL (UNII: 5M0MWY797U) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) TOCOPHEROL (UNII: R0ZB2556P8) CODIUM FRAGILE (UNII: MSE6FUU012) LINALOOL, (+)- (UNII: F4VNO44C09) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) FARNESOL (UNII: EB41QIU6JL) EUGENOL (UNII: 3T8H1794QW) .BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF) WATER (UNII: 059QF0KO0R) COCO-CAPRYLATE (UNII: 4828G836N6) COCONUT OIL (UNII: Q9L0O73W7L) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) NIACINAMIDE (UNII: 25X51I8RD4) GLYCERIN (UNII: PDC6A3C0OX) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) SUCROSE COCOATE (UNII: 3H18P0UK73) XANTHAN GUM (UNII: TTV12P4NEE) PHENOXYETHANOL (UNII: HIE492ZZ3T) GLUCONOLACTONE (UNII: WQ29KQ9POT) MARINE COLLAGEN, SOLUBLE (UNII: 8JC99XGU4W) LAMINARIA DIGITATA (UNII: 15E7C67EE8) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51514-0352-1 1 g in 1 TUBE; Type 0: Not a Combination Product 08/31/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 08/31/2016 Labeler - Autumn Harp Inc. (064187883) Establishment Name Address ID/FEI Business Operations Autumn Harp Inc 064187883 manufacture(51514-0352)
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