COOLA MINERAL SUN SILK CREME SUNSCREEN SPF 30- zinc oxide lotion 
COOLA LLC

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.

----------

COOLA Mineral Sun Silk Crème Sunscreen SPF 30

DRUG FACTS

Active ingredients

Zinc Oxide 15.8%

Purpose

Sunscreen

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 skin rash occurs

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

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.

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 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 information


* protect this product from excessive heat and direct sun

Questions or comments? Call 760-940-2125

How to use:

Apply daily to cleansed skin,

15 minutes before sun exposure.

Dispense into palm of hand and

apply evenly across face and

neck using upward strokes,

Questionsor Comments? Call 760-940-2125

Package Labeling

SPF

30

COOLA

MINERAL SUN SILK CREME

SUNSCREEN SPF 30

1.5 FL OZ /44 mL

©2021 COOLA. Distributed by: COOLA LLC, located in

Sunny & Cool San Diego, CA 92010. All Rights Reserved.

070-01 1.5Oz Box

070-01 1.5Oz Botle

res

COOLA MINERAL SUN SILK CREME SUNSCREEN  SPF 30
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79753-070
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE158 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79753-070-011 in 1 BOX02/01/2023
144 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/01/2023
Labeler - COOLA LLC (956990290)
Registrant - Bentley Laboratories, LLC (068351753)

Revised: 4/2023
Document Id: 01e221ba-9bce-4d69-b576-de96d6074b44
Set id: bb9dd9a9-ec01-4e94-9172-3a72e68a417a
Version: 1
Effective Time: 20230404
 
COOLA LLC