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Babyganics (Autumn Harp, Inc.)

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SPRAY 177 mL in 1 BOTTLE (51514-0235-1) Label Information

Complete Babyganics Information

  • 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 Type HUMAN OTC DRUG Item Code (Source) NDC:51514-0235
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 11.2 mL  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 mL  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5.0 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51514-0235-1 177 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 02/23/2012
    Labeler - Autumn Harp, Inc. (064187883)
    Establishment
    Name Address ID/FEI Business Operations
    Autumn Harp, Inc. 064187883 manufacture