Label: BABO SPF 30 CLEAR ZINC FRAGRANCE FREE- mineral sunscreen 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 November 1, 2020

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 finalpart35211/01/2020
    Labeler - Babo Botanicals, Inc. (058258734)
    Registrant - Bell International Laboratories (967781555)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bell International Laboratories967781555manufacture(79265-8077)