Label: BABO SPF 30 CLEAR ZINC FRAGRANCE FREE- mineral sunscreen lotion
- NDC Code(s): 79265-8077-3
- 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 January 31, 2022
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- Official Label (Printer Friendly)
- 79265-8077 SPF 30 Clear Zinc, Fragrance Free Sunscreen Lotion
- Active Ingredients
- Purpose
- Stop use and ask doctor
- Warnings
- Keep Out of Reach of Children
- Directions
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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
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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
- Questions and comments?
- Information Panel
- Uses
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
BABO SPF 30 CLEAR ZINC FRAGRANCE FREE
mineral sunscreen lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79265-8077 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 16 g in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:79265-8077-3 89 mL in 1 TUBE; 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 part352 11/01/2020 Labeler - Babo Botanicals, Inc. (058258734)
