MINERAL SUN SILK MOISTURIZER SUNSCREEN SPF 30- zinc oxide 13.5% cream

Mineral Sun Silk Moisturizer Sunscreen by

Drug Labeling and Warnings

Mineral Sun Silk Moisturizer Sunscreen by is a Otc medication manufactured, distributed, or labeled by COOLA LLC, Bentley Laboratories, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active ingredients

Zinc Oxide 13.5%

PURPOSE

Purpose

Sunscreen

WARNINGS

Warnings

For external use only

When using this product keep out of eyes. Rinse with water to remove

Stop use and ask doctor if skin rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

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

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

Other information

* protect this product from excessive heat and direct sun

QUESTIONS

Questionsor Comments? Call 760-940-2125

Package Labeling - COOLA Mineral Sun Silk Moisturizer Sunscreen SPF 30

SPF
30

70% +
Organic

COOLA

Mineral Sun Silk Moisturizer

Sunscreen 

Ultra-Rich Priming Cream

Broad Spectrum SPF 30

1.5 FL OZ / 44 mL

2020 COOLA. Distributed by: 

COOLA LLC, located in Sunny &

Cool San Diego, CA 92009.

All Rights Reserved. www.coola.com

Carton

Jar

INGREDIENTS AND APPEARANCE

MINERAL SUN SILK MOISTURIZER SUNSCREEN  SPF 30
zinc oxide 13.5% cream

Product 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)