Label: BABO BABY SKIN MINERAL SUNSCREEN FF- mineral sunscreen spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 12, 2024

If you are a consumer or patient please visit this version.

  • SPF 30 Baby Skin Mineral Non-Aerosol Sunscreen Pump Spray, FF

    This product is an OTC sunscreen manufactured according to the Sunscreen Final Rule. Active ingredient: Zinc Oxide

  • Active Ingredient

    Zinc Oxide 14.5%; Purpose: Sunscreen

  • 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

  • Purpose

    Sunscreen

  • Warnings

    For external use only.

  • Do not use

    • on damaged or broken skin.
  • When using this product

    Keep out of eye. Rinse with water to remove.

  • Stop use and ask 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

    Apply liberally to exposed areas 15 minutes before sun exposure. Reapply at least every two hours, after 80 minutes of swimming or sweating, or immediately after towel-drying.

    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 protection measures including: Limit time in the sun, especially from 10 a.m. – 2 p.m. and wear long-sleeve shirts, pants, hats, and sunglasses.

    Children under 6 months; ask a doctor.

  • Inactive Ingredients

    BENTONITE
    BISABOLOL*
    BUTYLOCTYL SALICYLATE
    CALENDULA OFFICINALIS FLOWER EXTRACT*
    CAPRYLHYDROXAMIC ACID
    CAPRYLIC/CAPRIC TRIGLYCERIDE
    CAPRYLYL GLYCOL
    CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL
    CELLULOSE GUM
    CETEARYL ALCOHOL
    CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT*
    COCO GLUCOSIDE
    GLYCERIN*
    HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL*
    JOJOBA ESTERS
    METHYL DIHYDROABIETATE
    MICROCRYSTALLINE CELLULOSE
    NASTURTIUM OFFICINALE (WATERCRESS) FLOWER/LEAF EXTRACT*
    POLYHYDROXYSTEARIC ACID
    PROPANEDIOL
    PUERARIA LOBATA (KUDZU) ROOT EXTRACT*
    SPIRAEA ULMARIA (MEADOWSWEET) FLOWER EXTRACT*
    TETRADECANE
    TOCOPHEROL
    WATER (AQUA)

  • Other information

    Protect this product from excessive heat and direct sun. May stain some fabrics. You may report a serious adverse event to the phone number or address provided below.

  • Questions and comments

    Call toll free 1-877-537-BABO Monday-Friday 9:00 am - 5:00 EST

  • PRINCIPAL DISPLAY PANEL

    79265-8579-6 6 fl. oz. / 177 mL

    8579 Front and Drug Facts Panel

  • INGREDIENTS AND APPEARANCE
    BABO BABY SKIN MINERAL SUNSCREEN FF 
    mineral sunscreen spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79265-8579
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE14.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    PUERARIA MONTANA VAR. LOBATA ROOT (UNII: PET93F4I3C) 0.00015 mL  in 100 mL
    TETRADECANE (UNII: 03LY784Y58) 5 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 53.8608 mL  in 100 mL
    BENTONITE (UNII: A3N5ZCN45C) 1.5 mL  in 100 mL
    CAPRYLYL GLYCOL (UNII: 00YIU5438U) 0.7 mL  in 100 mL
    LEVOMENOL (UNII: 24WE03BX2T) 0.3 mL  in 100 mL
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) 1.105 mL  in 100 mL
    CHAMOMILE (UNII: FGL3685T2X) 0.00015 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 0.15845 mL  in 100 mL
    SUNFLOWER OIL (UNII: 3W1JG795YI) 6 mL  in 100 mL
    HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58) 0.38 mL  in 100 mL
    METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F) 2 mL  in 100 mL
    PROPANEDIOL (UNII: 5965N8W85T) 1 mL  in 100 mL
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) 0.09 mL  in 100 mL
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) 5 mL  in 100 mL
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) 0.00015 mL  in 100 mL
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) 0.15 mL  in 100 mL
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) 3 mL  in 100 mL
    SAFFLOWER OIL (UNII: 65UEH262IS) 3 mL  in 100 mL
    COCO GLUCOSIDE (UNII: ICS790225B) 0.595 mL  in 100 mL
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) 0.66 mL  in 100 mL
    NASTURTIUM OFFICINALE FLOWERING TOP (UNII: W1N2U8I64G) 0.00015 mL  in 100 mL
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) 0.25 mL  in 100 mL
    FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6) 0.00015 mL  in 100 mL
    TOCOPHEROL (UNII: R0ZB2556P8) 0.75 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79265-8579-6177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02011/01/202012/31/2024
    Labeler - Babo Botanicals, Inc. (058258734)