BABYGANICS SPF 50 (OCTINOXATE, OCTISALATE, AND ZINC) SPRAY [AUTUMN HARP, INC.]

BABYGANICS SPF 50 (OCTINOXATE, OCTISALATE, AND ZINC) SPRAY [AUTUMN HARP, INC.]
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NDC 51514-0235-1
Set ID f40a8efa-2cbe-4e99-aba3-66eb59b70332
Category HUMAN OTC DRUG LABEL
Packager Autumn Harp, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • Active Ingredients

    Active Ingredients                                                      Purpose

    Octinoxate 7.5%, Octisalate 5.0%, Zinc Oxide 11.2%     Sunscreen

  • Uses

    Uses

    helps prevent sunburn

    if used as directed with other sun protection measures (see Directions), decrease the risk of skin cancer and early skin aging caused by the sun

  • Warnings

    Warnings

    For external use only

  • Do not use

    Do not use on damaged or broken skin

  • When using this product

    When using this product keep out of eyes, Rinse with water to remove.

  • Stop use and ask a doctor

    Stop use and ask a doctor if rash occurs

  • Keep out of reach of children

    Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Directions

    apply liberally 15 minutes before sun exposure

    reapply

    after 80 minutes of swimming or sweating

    immediately after towel drying

    at least every 2 hours

    children under 6 months of age: ask a doctor

  • Sun Protection Measures

    Sun Protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk of skin cancer and early skin aging. To decrease this risk sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

    limit time in the sun, especially from 10 am - 2 pm.

    wear long-sleeved shirts, pants, hats, andsunglasses

  • Other Information

    Other information

    protect from excessive heat and direct sun

  • Inactive ingredients

    Inactive Ingredients:  Water, Glycerin, Caprylic/Capric Triglyceride, Aloe Barbadensis Leaf Juice, VP/hexadecene copolymer, Cetearyl Glucoside, Phenethyl Alcohol, Glyceryl Caprylate, Polyacrylate Crosspolymer-6, Cetearyl Alcohol, Citric Acid.

  • Label

    Label

  • INGREDIENTS AND APPEARANCE
    BABYGANICS  SPF 50
    octinoxate, octisalate, and zinc spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51514-0235
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide112 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51514-0235-1177 mL in 1 BOTTLE; Type 0: Not a Combination Product06/21/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/23/2012
    Labeler - Autumn Harp, Inc. (064187883)
    Establishment
    NameAddressID/FEIBusiness Operations
    Autumn Harp, Inc.064187883manufacture(51514-0235)

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