Label: COOLA MINERAL SUN SILK CREME SUNSCREEN SPF 30- zinc oxide lotion
- NDC Code(s): 79753-070-01
- Packager: COOLA LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 April 4, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- DRUG FACTS
- PURPOSE
- WARNINGS AND PRECAUTIONS
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DOSAGE & ADMINISTRATION
Directions
* shake well * apply liberally 15 minutes before sun exposure
* 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 aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun 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 INGREDIENT
Inactive ingredients
Water, Caprylic/Capric Triglyceride, Dimethicone,
Polyhydroxystearic Acid, Aloe Barbadensis Leaf Juice
Powder, Jasminum Sambac (Jasmine) Leaf Cell
Extract, Theobroma Cacao (Cocoa) Seed Extract,
Schinus Molle Extract, Niacinamide, Hydroxyethyl
Acrylate/Sodium Acryloyldimethyl Taurate Copolymer,
Propanediol, Butylene Glycol, Polyisobutene,
Methylpropanediol, Cetearyl Alcohol, Glyceryl Stearate
Citrate, PEG-7 Trimethylolpropane Coconut Ether,
Caprylyl Glycol, Sorbitan Isostearate,
Polyquaternium-80, Glyceryl Caprylate,
Didecyldimonium Chloride - OTHER SAFETY INFORMATION
- QUESTIONS
- INSTRUCTIONS FOR USE
- QUESTIONS
- Package Labeling
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INGREDIENTS AND APPEARANCE
COOLA MINERAL SUN SILK CREME SUNSCREEN SPF 30
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79753-070 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 158 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) COCOA (UNII: D9108TZ9KG) SCHINUS MOLLE FRUITING TOP (UNII: T8L6O1KSB4) POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) NIACINAMIDE (UNII: 25X51I8RD4) METHYLPROPANEDIOL (UNII: N8F53B3R4R) JASMINUM SAMBAC FLOWER (UNII: 2S686I937F) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) PROPANEDIOL (UNII: 5965N8W85T) DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B) ALOE VERA LEAF (UNII: ZY81Z83H0X) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4) DIMETHICONE (UNII: 92RU3N3Y1O) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) GLYCERYL STEARATE CITRATE (UNII: WH8T92A065) PEG-7 TRIMETHYLOLPROPANE COCONUT ETHER (UNII: MVJ3AD73GG) POLYQUATERNIUM-80 (UNII: 3N8LGV97HR) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79753-070-01 1 in 1 BOX 02/01/2023 1 44 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/01/2023 Labeler - COOLA LLC (956990290) Registrant - Bentley Laboratories, LLC (068351753)
