Label: MINERAL SUN SILK MOISTURIZER SUNSCREEN SPF 30- zinc oxide 13.5% cream
- NDC Code(s): 79753-078-01
- Packager: COOLA LLC
- 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 April 9, 2023
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- DRUG FACTS
- PURPOSE
- WARNINGS
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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
Aloe Barbadensis Leaf Juice (ORGANIC), Cocos Nucifera (Coconut) Oil (ORGANIC), Simmondsia Chinensis
(Jojoba) Seed Oil (ORGANIC), Caprylic/Capric Triglyceride, Water/Aqua/Eau, Olive Oil Polyglyceryl-6 Esters,
Polyhydroxystearic Acid, Cetearyl Alcohol, Jasminum Sambac (Jasmine) Leaf Cell Extract, Theobroma Cacao
(Cocoa) Seed Extract, Schinus Molle Extract, Nymphaea Caerulea Flower Extract, Paeonia Lactiflora Leaf Cell
Extract, Nelumbo Nucifera Flower Extract, Polyurethane-79, Polyacrylate Crosspolymer-6, Polyglyceryl-6
Pentaoleate, Propanediol, Glycerin, Butylene Glycol, Citric Acid, Polymethylsilsesquioxane, Xanthan Gum,
Methylpropanediol, Caprylyl Glycol, Polyquaternium-80, Didecyldimonium Chloride, Fragrance (Natural) - OTHER SAFETY INFORMATION
- QUESTIONS
- Package Labeling - COOLA Mineral Sun Silk Moisturizer Sunscreen SPF 30
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INGREDIENTS AND APPEARANCE
MINERAL SUN SILK MOISTURIZER SUNSCREEN SPF 30
zinc oxide 13.5% creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79753-078 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 135 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) COCONUT OIL (UNII: Q9L0O73W7L) JOJOBA OIL (UNII: 724GKU717M) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) WATER (UNII: 059QF0KO0R) OLIVE OIL POLYGLYCERYL-6 ESTERS (UNII: 4KDO9AFM9I) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) JASMINUM SAMBAC FLOWER (UNII: 2S686I937F) COCOA (UNII: D9108TZ9KG) SCHINUS MOLLE FRUITING TOP (UNII: T8L6O1KSB4) NYMPHAEA CAERULEA FLOWER (UNII: S9560USZ74) PAEONIA LACTIFLORA FLOWER (UNII: R73687A534) NELUMBO NUCIFERA FLOWER (UNII: 61W322NLDV) AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9) PROPANEDIOL (UNII: 5965N8W85T) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK) XANTHAN GUM (UNII: TTV12P4NEE) METHYLPROPANEDIOL (UNII: N8F53B3R4R) CAPRYLYL GLYCOL (UNII: 00YIU5438U) POLYQUATERNIUM-80 (UNII: 3N8LGV97HR) DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79753-078-01 1 in 1 CARTON 02/01/2023 1 44 mL in 1 JAR; 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 02/01/2023 Labeler - COOLA LLC (956990290) Registrant - Bentley Laboratories, LLC (068351753)
