Label: HATCH MAMA SUNNY MAMA FACE MINERAL SUNSCREEN BROAD SPECTRUM SPF 50 lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 22, 2022

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  • Active Ingredients

    Zinc Oxide 12%

  • 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 docor if rash occurs
    Keep out of reach of children. If swalled, get medical help or contact a Poison Control Center right away.

  • Directions

    • apply liberally 15 minutes before sun exposure
    • reapply:
    • after 40 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 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, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Propanediol, Jojoba Esters, Methylheptyl Isostearate, Tridecyl Salicylate, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Nylon-12, Niacinamide, Methylpropanediol, Coco-Caprylate, Silica, Sodium Chloride, Polyglyceryl-2 Dipolyhydroxystearate, Caprylyl Glycol, Bisabolol, Allantoin, Oryza Sativa (Rice) Bran Extract, Lecithin, Phenylpropanol, Helianthus Annuus (Sunflower) Extract, Tocopherol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tetrasodium Glutamate Diacetate, Sodium Hydroxide

  • Other Information

    • protect the product in this container from excessive
    heat and direct sun

  • Principal Display Panel

    82117-200

  • INGREDIENTS AND APPEARANCE
    HATCH MAMA SUNNY MAMA FACE MINERAL SUNSCREEN BROAD SPECTRUM SPF 50 
    hatch mama sunny mama face mineral sunscreen broad spectrum spf 50 lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82117-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE12 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    C12-15 ALCOHOLS (UNII: 2C8M6XLB5C)  
    CAPRYLIC/CAPRIC ACID (UNII: DI775RT244)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    JOJOBA ACID (UNII: MO7HV04S9Y)  
    METHYLHEPTYL ISOSTEARATE (UNII: 981F40Q9FF)  
    POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y)  
    NYLON-12 (UNII: 446U8J075B)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    COCO-CAPRYLATE (UNII: 4828G836N6)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ORYZA SATIVA WHOLE (UNII: 84IVV0906Z)  
    HELIANTHUS ANNUUS WHOLE (UNII: 17S27ZT6KR)  
    BISABOLOL OXIDE A (UNII: 16AE65F94Y)  
    ALLANTOIN (UNII: 344S277G0Z)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CAMELLIA SINENSIS SEED (UNII: MRL49Z8AC4)  
    ROSMARINUS OFFICINALIS FLOWER (UNII: NR1A27F29O)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82117-200-051 in 1 CARTON02/22/2022
    150 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35202/22/2022
    Labeler - Hatch Collection LLC (064833206)