Label: BABO BOTANICALS DAILY SHEER MINERAL SUNSCREEN SPF 40- zinc oxide, titanium dioxide lotion
- NDC Code(s): 79265-8708-1
- 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 21, 2022
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- Active Ingredients
- Purpose
- Uses
- Warnings
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Directions
- Apply liberally 15 minutes before sun exposure. Children under 6 months of age: Ask a doctor
- use a water resistant sunscreen if swimming or sweating
- reapply:
- immediately after towel drying
- at least every 2 hours
Sun Protection Measures Sun exposure increases risk of skin cancer and early skin aging. To decrease risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10a.m. - 2p.m. Wear long sleeved shirts, pants, hats and sunglasses.
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Inactive ingredients
Aloe Barbadensis Leaf Juice*, Aluminum Hydroxide, Beeswax*, Butyrospermum Parkii (Shea Butter)*, Camellia Sinensis (Green Tea) Leaf Extract, Cetearyl Alcohol, Coco-Glucoside, Dehydroxanthan Gum, Dicaprylyl Carbonate, Ethylhexylglycerin, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Hydrogen Dimethicone, Hydrolyzed Wheat Protein/PVP Crosspolymer, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Methyl Dihydroabietate, Myristyl Alcohol, Myristyl Glucoside, Persea Gratissima (Avocado) Oil, Phenethyl Alcohol, Pongamia Pinnata Seed Oil, Ricinus Communis (Castor) Seed Oil, Rosa Canina Fruit Extract, Simmondsia Chinensis (Jojoba) Seed Oil*, Triethoxycaprylylsilane, Water (Aqua).
*Certified Organic Ingredients
- Package Label
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INGREDIENTS AND APPEARANCE
BABO BOTANICALS DAILY SHEER MINERAL SUNSCREEN SPF 40
zinc oxide, titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79265-8708 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 33 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 59 mg in 1 mL Inactive Ingredients Ingredient Name Strength TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) JOJOBA OIL (UNII: 724GKU717M) CASTOR OIL (UNII: D5340Y2I9G) ROSA CANINA FRUIT (UNII: 3TNW8D08V3) PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) DEHYDROXANTHAN GUM (UNII: 63ZP7I1BQO) SUNFLOWER OIL (UNII: 3W1JG795YI) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) AVOCADO OIL (UNII: 6VNO72PFC1) WATER (UNII: 059QF0KO0R) SHEA BUTTER (UNII: K49155WL9Y) MYRISTYL GLUCOSIDE (UNII: 6AK28695LF) KARUM SEED OIL (UNII: 62160PU6FJ) COCO GLUCOSIDE (UNII: ICS790225B) MYRISTYL ALCOHOL (UNII: V42034O9PU) ALOE VERA LEAF (UNII: ZY81Z83H0X) GLYCERIN (UNII: PDC6A3C0OX) GREEN TEA LEAF (UNII: W2ZU1RY8B0) YELLOW WAX (UNII: 2ZA36H0S2V) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79265-8708-1 1 in 1 BOX 03/01/2023 1 50 mL 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 03/01/2023 Labeler - Babo Botanicals, Inc. (058258734)
