FDA.reportPublic FDA data

COOLA Mineral Sun Silk Creme Sunscreen

Manufacturer
COOLA LLC | Bentley Laboratories, LLC
Effective date
2024-12-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:49:17

Label at a glance#

ProductCOOLA Mineral Sun Silk Creme Sunscreen SPF 30
Active ingredientZINC OXIDE
Label structure11 sections

Label contents#

Full prescribing information#

DRUG FACTS

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Zinc Oxide 15.8%

OTC - PURPOSE SECTION

Purpose

Sunscreen

INDICATIONS & USAGE SECTION

Uses

Helps prevent sunburn

If used as directed with other sun protection measures (See Directions), decreases the risk of skin cancer and early skin aging cause by the sun.

WARNINGS SECTION

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.

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask doctor if skin rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

Other information


* protect this product from excessive heat and direct sun

OTC - QUESTIONS SECTION

Questions or comments? Call 760-940-2125

INSTRUCTIONS FOR USE SECTION

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,

OTC - QUESTIONS SECTION

Questionsor Comments? Call 760-940-2125

Package Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 Box070-01 1.5Oz Box

070-01 1.5Oz Botle070-01 1.5Oz Botle

res

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79753-070-01COOLA Mineral Sun Silk Creme SunscreenSPF 3044 mL in 1 BOTTLELOTION442
79753-070-01COOLA Mineral Sun Silk Creme SunscreenSPF 301 in 1 BOXLOTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79753-070COOLA MINERAL SUN SILK CREME SUNSCREEN SPF 30 (ZINC OXIDE) LOTION [COOLA LLC]2Current NDC, 2 package rows20241228_bb9dd9a9-ec01-4e94-9172-3a72e68a417a.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79753-07079753-070-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
COCOAD9108TZ9KGIACT
SCHINUS MOLLE FRUITING TOPT8L6O1KSB4IACT
POLYISOBUTYLENE (1000 MW)5XB3A63Y52IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
NIACINAMIDE25X51I8RD4IACT
ZINC OXIDESOI2LOH54ZACTIB
METHYLPROPANEDIOLN8F53B3R4RIACT
JASMINUM SAMBAC FLOWER2S686I937FIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT
PROPANEDIOL5965N8W85TIACT
DIDECYLDIMONIUM CHLORIDEJXN40O9Y9BIACT
ALOE VERA LEAFZY81Z83H0XIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)86FQE96TZ4IACT
DIMETHICONE92RU3N3Y1OIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
GLYCERYL STEARATE CITRATEWH8T92A065IACT
PEG-7 TRIMETHYLOLPROPANE COCONUT ETHERMVJ3AD73GGIACT
POLYQUATERNIUM-803N8LGV97HRIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COOLA Mineral Sun Silk Creme Sunscreen SPF 30ZINC OXIDECOOLA LLCbb9dd9a9-ec01-4e94-9172-3a72e68a417a2024-12-27WarningsExact identifier
ndc (package): 79753-070-01
ndc (product): 79753-070
ndc11 (package): 79753007001
spl id: 1eebd16e-0749-460d-927e-784ea1c2efa6
spl set id: bb9dd9a9-ec01-4e94-9172-3a72e68a417a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.