Label: BABO BOTANICALS SWIM AND SPORT MINERAL SUNSCREEN SPF 30- zinc oxide spray
- NDC Code(s): 79265-8775-1
- Packager: Babo Botanicals, Inc.
- 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 April 6, 2023
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- Drug Facts
- Active ingredient
- Purpose
- Uses
- Warnings
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Directions
- Shake well
- Apply liberally 15 minutes before sun exposure.
- Reapply after 80 minutes of swimming or sweating, immediately after towel-drying, at least every two 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 of age: ask a doctor
- Other information
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Inactive ingredients
Water (Aqua), Helianthus Annuus (Sunflower) Seed Oil, Butyloctyl Salicylate, Tetradecane, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Seed Oil, Methyl Dihydroabietate, Bentonite, Cetearyl Alcohol, Propanediol, Passiflora Edulis (Maracuja) Seed Oil, Jojoba Esters, Tocopherol (Vitamin E), Glycerin, Bisabolol, Calendula Officinalis Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract, Nasturtium Officinale (Watercress) Flower/Leaf Extract, Spiraea Ulmaria (Meadowsweet) Flower Extract, Microcrystalline Cellulose, Coco-Glucoside, Polyhydroxystearic Acid, Caprylhydroxamic Acid, Cellulose Gum, Caprylyl Glycol.
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INGREDIENTS AND APPEARANCE
BABO BOTANICALS SWIM AND SPORT MINERAL SUNSCREEN SPF 30
zinc oxide sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79265-8775 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 145 mg in 1 mL Inactive Ingredients Ingredient Name Strength CAPRYLYL GLYCOL (UNII: 00YIU5438U) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) BENTONITE (UNII: A3N5ZCN45C) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F) FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6) PASSIFLORA EDULIS SEED OIL (UNII: F3VOA31UHQ) JOJOBA OIL (UNII: 724GKU717M) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) SUNFLOWER OIL (UNII: 3W1JG795YI) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) SAFFLOWER OIL (UNII: 65UEH262IS) PROPANEDIOL (UNII: 5965N8W85T) TETRADECANE (UNII: 03LY784Y58) WATER (UNII: 059QF0KO0R) TOCOPHEROL (UNII: R0ZB2556P8) COCO GLUCOSIDE (UNII: ICS790225B) LEVOMENOL (UNII: 24WE03BX2T) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) GLYCERIN (UNII: PDC6A3C0OX) CHAMOMILE (UNII: FGL3685T2X) NASTURTIUM OFFICINALE (UNII: YH89GMV676) JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79265-8775-1 177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 04/02/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 04/02/2023 Labeler - Babo Botanicals, Inc. (058258734)
