Label: BABO SPF 30 CLEAR ZINC FRAGRANCE FREE SPORT- mineral sunscreen stick
- NDC Code(s): 79265-8075-0, 79265-8075-1
- 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 January 28, 2022
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- Active Ingredient
- Purpose
- Uses
- Warnings
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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 • 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
BEESWAX*
BUTYROSPERMUM PARKII (SHEA) BUTTER*
CALOPHYLLUM TACAMAHACA SEED OIL*
CANNABIS SATIVA SEED OIL*
EUPHORBIA CERIFERA (CANDELILLA) WAX
JOJOBA ESTERS
OCTYLDODECYL OLEATE
ORYZA SATIVA (RICE) BRAN OIL*
PERSEA GRATISSIMA (AVOCADO) OIL*
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL*
THEOBROMA CACAO (COCOA) SEED BUTTER*
TOCOPHEROL*CERTIFIED ORGANIC INGREDIENTS
- Other Information
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INGREDIENTS AND APPEARANCE
BABO SPF 30 CLEAR ZINC FRAGRANCE FREE SPORT
mineral sunscreen stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79265-8075 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 15.326 g in 100 g Inactive Ingredients Ingredient Name Strength JOJOBA OIL (UNII: 724GKU717M) 7.5 mL in 100 g COCOA BUTTER (UNII: 512OYT1CRR) 3 mL in 100 g CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S) 0.01 mL in 100 g OCTYLDODECYL OLEATE (UNII: MCA43PK7MH) 8.75 mL in 100 g SHEA BUTTER (UNII: K49155WL9Y) 1 mL in 100 g CALOPHYLLUM TACAMAHACA SEED OIL (UNII: 05G85L61OE) 0.01 mL in 100 g RICE BRAN OIL (UNII: LZO6K1506A) 32.93 mL in 100 g HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58) 0.47 mL in 100 g WHITE WAX (UNII: 7G1J5DA97F) 6 mL in 100 g AVOCADO OIL (UNII: 6VNO72PFC1) 15 mL in 100 g TOCOPHEROL (UNII: R0ZB2556P8) 0.5 mL in 100 g CANDELILLA WAX (UNII: WL0328HX19) 9.5 mL in 100 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79265-8075-0 1 in 1 BOX 11/01/2020 1 NDC:79265-8075-1 17 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product 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)