Label: BABO SPF 30 SHEER ZINC SUNSCREEN- mineral sunscreen spray
- NDC Code(s): 79265-8097-6
- Packager: Babo Botanicals, Inc.
- Category: HUMAN OTC DRUG LABEL
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 21, 2022
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- Active Ingredient(s)
- Purpose
- Uses
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Warnings
For external use only.
When using this product
- keep out of eyes. Rinse with water to remove. Rinse with water to remove.
- use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
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Directions
Shake well before use • Hold container 4 to 6 inches from the skin to apply • Apply liberally 15 minutes before sun exposure • Do not spray directly into face • Do not spray in windy condition • Use in well-ventilated area • Reapply: After 80 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 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
- Other information
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Inactive ingredients
Water (Aqua), Butyloctyl Salicylate, Bentonite, Carthamus Tinctorius (Safflower) Seed Oil, Heptyl Undecylenate, Methyl Dihydroabietate, Aloe Barbadensis (Aloe Vera) Leaf Juice, Jojoba Esters, Helianthus Annuus (Sunflower) Seed Oil*, Calendula Officinalis Flower Extract*, Chamomilla Recutita (Matricaria) Flower Extract*, Nasturtium Officinale (Watercress) Flower/Leaf Extract*, Spiraea Ulmaria (Meadowsweet) Flower Extract*, Glycerin, Coco-Glucoside, Caprylyl Glycol, Caprylhydroxamic Acid, Cetearyl Alcohol.
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INGREDIENTS AND APPEARANCE
BABO SPF 30 SHEER ZINC SUNSCREEN
mineral sunscreen sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79265-8097 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 12.222 g in 100 mL Inactive Ingredients Ingredient Name Strength CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CHAMOMILE (UNII: FGL3685T2X) SUNFLOWER OIL (UNII: 3W1JG795YI) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F) FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6) BENTONITE (UNII: A3N5ZCN45C) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) CAPRYLYL GLYCOL (UNII: 00YIU5438U) WATER (UNII: 059QF0KO0R) SAFFLOWER OIL (UNII: 65UEH262IS) HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58) NASTURTIUM OFFICINALE FLOWERING TOP (UNII: W1N2U8I64G) COCO GLUCOSIDE (UNII: ICS790225B) HEPTYL UNDECYLENATE (UNII: W77QUB6GXO) ALOE VERA LEAF (UNII: ZY81Z83H0X) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79265-8097-6 177 mL in 1 CAN; Type 0: Not a Combination Product 11/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 11/01/2020 Labeler - Babo Botanicals, Inc. (058258734)
