Label: BABO SPF 30 CLEAR ZINC FRAGRANCE FREE- mineral sunscreen lotion

  • 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.

  • 79265-8077 SPF 30 Clear Zinc, Fragrance Free Sunscreen Lotion

    79265-8077-3 3 fl. oz.

    This is an OTC Sunscreen product manufactured pursuant to the sunscreen final monograph, Part352.

  • Active Ingredients

    Zinc Oxide 16.0%

  • Purpose

    Purpose: Sunscreen

  • Stop use and ask doctor

    Stop use and ask doctor if rash occurs.

  • 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 children. If a product is swallowed get medical help or contact a Poison Control center right away.

  • Keep Out of Reach of Children

    Keep out of reach of children. If a product is 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

    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. • Wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months: ask a doctor

  • Inactive Ingredients

    ARACHIDYL ALCOHOL, ARACHIDYL GLUCOSIDE, BEHENYL ALCOHOL, BISABOLOL*, BUTYLOCTYL SALICYLATE, BUTYROSPERMUM PARKII (SHEA BUTTER), CALENDULA OFFICINALIS FLOWER EXTRACT*, CAPRYLHYDROXAMIC ACID, CAPRYLYL GLYCOL, CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, CELLULOSE GUM, CETEARYL ALCOHOL, CETYL ALCOHOL, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT*, CITRIC ACID, COCO-GLUCOSIDE, COCOS NUCIFERA (COCONUT) OIL, GLYCERIN, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, METHYL DIHYDROABIETATE, MICROCRYSTAL-LINE CELLULOSE, NASTURTIUM OFFICINALE FLOWER/LEAF EXTRACT*, POLYHYDROXYSTEARIC ACID, PUERARIA LOBATA ROOT EXTRACT*, SODIUM GLUCONATE, SODIUM HYALURONATE, SODIUM STEAROYL GLUTAMATE, SPIRAEA ULMARIA FLOWER EXTRACT*, THEOBROMA CACAO (COCOA) SEED BUTTER*, TOCOPHEROL, WATER (AQUA). *Certified Organic Ingredients

  • Other Information

    Protect this product from excessive heat and direct sun

  • Questions and comments?

    Questions and comments?Call 1-877-537-BABO

  • Information Panel

    Dist: by Babo Botanicals, Inc.

    14 Harwood Court, Scarsdale, NY 10583

    1.877.537.BABO www.babobotanicals.com

    MADE IN THE USA with US & imported materials.

  • 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.

  • Principal Display Panel

    Babo Botanicals

    Clear Zinc Sunscreen

    Broad Spectrum SPF 30

    Hypoallergenic

    Fragrance Free

    For Babies, Kids & Grown Ups Too!

    3 fl oz / 89 ml

    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    BABO SPF 30 CLEAR ZINC FRAGRANCE FREE 
    mineral sunscreen lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79265-8077
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE16 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 50.032 mL  in 100 mL
    COCONUT OIL (UNII: Q9L0O73W7L) 5 mL  in 100 mL
    SUNFLOWER OIL (UNII: 3W1JG795YI) 5.1 mL  in 100 mL
    HYALURONATE SODIUM (UNII: YSE9PPT4TH) 0.2 mL  in 100 mL
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) 1.3 mL  in 100 mL
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) 0.306 mL  in 100 mL
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) 0.99 mL  in 100 mL
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) 0.25 mL  in 100 mL
    METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F) 3 mL  in 100 mL
    NASTURTIUM OFFICINALE FLOWERING TOP (UNII: W1N2U8I64G) 0.002 mL  in 100 mL
    PUERARIA MONTANA VAR. LOBATA ROOT (UNII: PET93F4I3C) 0.002 mL  in 100 mL
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) 0.002 mL  in 100 mL
    CHAMOMILE (UNII: FGL3685T2X) 0.002 mL  in 100 mL
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.2 mL  in 100 mL
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) 1.3 mL  in 100 mL
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) 0.14 mL  in 100 mL
    COCOA BUTTER (UNII: 512OYT1CRR) 0.8 mL  in 100 mL
    DOCOSANOL (UNII: 9G1OE216XY) 0.504 mL  in 100 mL
    LEVOMENOL (UNII: 24WE03BX2T) 0.3 mL  in 100 mL
    FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6) 0.002 mL  in 100 mL
    TOCOPHEROL (UNII: R0ZB2556P8) 0.75 mL  in 100 mL
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) 1.06 mL  in 100 mL
    SODIUM GLUCONATE (UNII: R6Q3791S76) 0.2 mL  in 100 mL
    SHEA BUTTER (UNII: K49155WL9Y) 2.1 mL  in 100 mL
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) 0.15 mL  in 100 mL
    CAPRYLYL GLYCOL (UNII: 00YIU5438U) 0.7 mL  in 100 mL
    SAFFLOWER OIL (UNII: 65UEH262IS) 3 mL  in 100 mL
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) 5 mL  in 100 mL
    CETYL ALCOHOL (UNII: 936JST6JCN) 0.75 mL  in 100 mL
    COCO GLUCOSIDE (UNII: ICS790225B) 0.7 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 0.158 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79265-8077-389 mL in 1 TUBE; Type 0: Not a Combination Product11/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02011/01/202011/30/2026
    Labeler - Babo Botanicals, Inc. (058258734)