Label: BABY BARE REPUBLIC MINERAL SUNSCREEN SOFTSTICK SPF 50- zinc oxide stick

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 19, 2023

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  • ACTIVE INGREDIENT

    Drug Facts

    Active Ingredients

    Zinc Oxide 17.9%

    Purpose

    Suncreen

  • INDICATIONS & USAGE

    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

    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 doctor if skin rash occurs

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    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
    ●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 spection SPF of 15 or higher and other sun protection
    measures including: SPF of 15 or higher and other sun protection
    ● 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 INGREDIENT

    Inactive IngredientsButyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Carthamus Tinctorius Safflower) Seed Oil, Chamomilla Recutita (Matricaria) Flower Extract, Dimethicone, Ethyl Ferulate, Gossypium Herbaceum (Cotton) Seed Oil, Helianthus Annuus (Sunflower) Seed Wax, Hydrogenated Rapeseed Oil, Isododecane, Neopentyl Glycol Diheptanoate, Polyhydroxystearic Acid, Polymethylsilsesquioxane, Stearyl Alcohol, Tocopherol, Triethoxycaprylylsilane

  • OTHER SAFETY INFORMATION

    Other information

    • protect this product from excessive heat and direct sun
  • SPL UNCLASSIFIED SECTION

    Questions or comments?
    Call 760-940-2125

  • COOLA Label

    BABY BARE

    REPUBLIC

    MINERAL SUNSCREEN

    Softstick

    0.9 OZ / 25 g

    *Hawaii Reef Friendly Sunscreen Oxybenzone & Octinoxate Free
    ©2021 COOLA. Distributed by: COOLA LLC, located in Sunny & Cool

    San Diego, CA 92010. All Rights Reserved.

    WWW.GOBAREOUTSIDE.COM


    BabyBare

    res

  • INGREDIENTS AND APPEARANCE
    BABY BARE REPUBLIC MINERAL SUNSCREEN SOFTSTICK SPF 50 
    zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79753-009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION17.9 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SHEA BUTTER (UNII: K49155WL9Y)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SAFFLOWER SEED OIL POLYGLYCERYL-6 ESTERS (UNII: R2Z4507WJN)  
    CHAMOMILE (UNII: FGL3685T2X)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ETHYL FERULATE (UNII: 5B8915UELW)  
    COTTONSEED OIL (UNII: H3E878020N)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    HYDROGENATED RAPESEED OIL (UNII: K168T6Y0YU)  
    ISODODECANE (UNII: A8289P68Y2)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79753-009-011 in 1 BLISTER PACK03/03/2021
    125 g in 1 CANISTER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02003/03/2021
    Labeler - COOLA LLC (956990290)
    Registrant - Bentley Laboratories, LLC (068351753)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bentley Laboratories, LLC068351753manufacture(79753-009)
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