DAILY PROTECTING SPF15 SUNSCREEN (LOTION) LOTION [AUTUMN HARP INC.]

DAILY PROTECTING SPF15 SUNSCREEN (LOTION) LOTION [AUTUMN HARP INC.]
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NDC 51514-0352-1
Set ID 376dcf11-a1ef-46a9-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager Autumn Harp Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • Drug Facts

  • Active Ingredient

    Zinc Oxide (10.0%)

  • Purpose

    Sunscreen

  • Uses:

    Helps prevent sunburn • If used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun.

  • Warnings:

    For external use only.Do not use on damaged or broken skin • When using this product, keep out of eyes. Rinse with water to remove • Stop use and ask a doctor if rash occurs • Keep out of reach of children • If product is swallowed, get medical help or contact a Poison Control Center right away.

  • 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.

  • 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

  • Other Information:

    Protect this product from excessive heat and direct sun.

  • Questions or Comments?

    Call toll free 1-877-317-3106

  • Principle Display Panel

    Tube LabelImage Contents

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  • INGREDIENTS AND APPEARANCE
    DAILY PROTECTING SPF15 SUNSCREEN 
    lotion lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51514-0352
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51514-0352-11 g in 1 TUBE; Type 0: Not a Combination Product08/31/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35208/31/2016
    Labeler - Autumn Harp Inc. (064187883)
    Establishment
    NameAddressID/FEIBusiness Operations
    Autumn Harp Inc064187883manufacture(51514-0352)

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