Label: BABY DONNA SHEER SPF SUNSCREEN STICK- zinc oxide stick

  • Category: HUMAN OTC DRUG LABEL

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 February 28, 2023

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  • Active Ingredient

    Zinc Oxide 19%

  • Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn. 
    • If used as directed with other other sun protection measures ( seedirections), 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 doctor if rash occurs
    • Keep out of reach of child. If product is swallowed, get medical help or contact a Poison Control Center right away.
  • Directions

    • Apply liberally 15min before sun exposure. Reapply after 80mins of swimming or sweating immediately after towel drying and at least every 2 hrs. For children under 6 months of age; ask a doctor.
    • 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 value 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-sleeved shirts, pants, hats, and sunglasses.
  • KEEP OUT OF REACH OF CHILDREN

  • Other Information

    • Protect this product from excessive heat and direct sun
  • Questions?

    Contact support@babydonna.com

  • Inactive Ingredients

    Caprylic Capric Triglycerides, Coconut Alkanes (and) Coco-Caprylate/Caprate Polyhydroxystearic Acid, Coco caprylate/caprate, Butyrospermum Parkii (Shea) Butter Copernicia Cerifera (Carnauba) Wax, Arachidyl Alcohol (and) Behenyl Alcohol (and) Arachidyl Glucoside Candelilla Wax (Euphorbia Cerifera), Cetearyl Alcohol 50, Hydrogenated Castor Oil, Glyceryl Caprylate Meadowfoam Seed Oil,Mixed Tocopherols (Vitamin E)

  • Product label

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  • INGREDIENTS AND APPEARANCE
    BABY DONNA SHEER SPF SUNSCREEN STICK 
    zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83265-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION19 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    COCONUT ALKANES (UNII: 1E5KJY107T)  
    POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)  
    COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83265-001-011 in 1 BOX03/01/2023
    116 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/01/2023
    Labeler - BabyDonna LLC (077317794)