Label: BABO BABY FACE MINERAL SUNSCREEN- mineral sunscreen stick
- NDC Code(s): 79265-8065-1
- 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 November 14, 2022
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- Active Ingredient
- Purpose
- Use
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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 swallowed get medical help or contact a Poison Control center right away. May stain some fabrics and surfaces.
- Keep Out of Reach of Children
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Directions
- Apply liberally to exposed areas 15 minutes before sun exposure. Children under 6 months: Ask a doctor.
- Reapply:
- after 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. and wear long-sleeve shirts, pants, hats, and sunglasses.
- Other information
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Inactive ingredients
Oryza Sativa (Rice) Bran Oil*, Persea Gratissima (Avocado) Oil*, Euphorbia Cerifera (Candelilla) Wax, Octyldodecyl Olivate, Simmondsia Chinensis (Jojoba) Seed Oil*, Beeswax*, Theobroma Cacao (Cocoa) Seed Butter*, Oryzanol, Jojoba Esters, Butyrospermum Parkii (Shea) Butter*, Calendula Officinalis Flower Extract*, Chamomilla Recutita (Matricaria) Flower Extract*, Nasturtium Officinale (Watercress) Flower/Leaf Extract*, Spiraea Ulmaria (Meadowsweet) Flower Extract*, Bisabolol*, Calophyllum Inophyllum (Tamanu) Seed Oil*, Helianthus Annuus (Sunflower) Seed Oil*, Tocopherol (Vitamin E).
*Certified Organic Ingredients
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INGREDIENTS AND APPEARANCE
BABO BABY FACE MINERAL SUNSCREEN
mineral sunscreen stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79265-8065 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 20.267 g in 100 g Inactive Ingredients Ingredient Name Strength TAMANU OIL (UNII: JT3LVK84A1) 0.01 mL in 100 g JOJOBA OIL (UNII: 724GKU717M) 7.5 mL in 100 g TOCOPHEROL (UNII: R0ZB2556P8) 0.75 mL in 100 g HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58) 0.833 mL in 100 g ORYZANOL (UNII: SST9XCL51M) 3 mL in 100 g WHITE WAX (UNII: 7G1J5DA97F) 6 mL in 100 g CHAMOMILE (UNII: FGL3685T2X) 0.0005 mL in 100 g LEVOMENOL (UNII: 24WE03BX2T) 0.2 mL in 100 g CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) 0.0005 mL in 100 g CANDELILLA WAX (UNII: WL0328HX19) 9.5 mL in 100 g SHEA BUTTER (UNII: K49155WL9Y) 1 mL in 100 g RICE BRAN OIL (UNII: LZO6K1506A) 24.09 mL in 100 g OCTYLDODECYL OLEATE (UNII: MCA43PK7MH) 8.75 mL in 100 g FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6) 0.0005 mL in 100 g COCOA BUTTER (UNII: 512OYT1CRR) 3 mL in 100 g CALOPHYLLUM TACAMAHACA SEED OIL (UNII: 05G85L61OE) 0.01 mL in 100 g SUNFLOWER OIL (UNII: 3W1JG795YI) 0.098 mL in 100 g AVOCADO OIL (UNII: 6VNO72PFC1) 15 mL in 100 g NASTURTIUM OFFICINALE FLOWERING TOP (UNII: W1N2U8I64G) 0.0005 mL in 100 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79265-8065-1 1 in 1 CARTON 11/01/2020 1 17 g in 1 TUBE; Type 0: Not a Combination Product 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)
