FDA.reportPublic FDA data

Mineral Sun Silk Moisturizer Sunscreen

Manufacturer
COOLA LLC | Bentley Laboratories, LLC
Effective date
2023-04-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:54:40

Label at a glance#

ProductMineral Sun Silk Moisturizer Sunscreen SPF 30
Active ingredientZINC OXIDE
Label structure8 sections

Label contents#

Full prescribing information#

DRUG FACTS

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Zinc Oxide 13.5%

OTC - PURPOSE SECTION

Purpose

Sunscreen

WARNINGS SECTION

Warnings

For external use only

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

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 SECTION

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

OTC - QUESTIONS SECTION

Questionsor Comments? Call 760-940-2125

Package Labeling - COOLA Mineral Sun Silk Moisturizer Sunscreen SPF 30

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

078-01 Box078-01 Box

Jar

078-01 Jar 13.5%078-01 Jar 13.5%

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79753-078-012025-01-30C16284748780-12cef2736-6999-d83d-e063-dadaa90ab31fCOOLA Mineral Sun Silk Moisturizer Sunscreen SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79753-078-01Mineral Sun Silk Moisturizer SunscreenSPF 301 in 1 CARTONCREAM11
79753-078-01Mineral Sun Silk Moisturizer SunscreenSPF 3044 mL in 1 JARCREAM441

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79753-078MINERAL SUN SILK MOISTURIZER SUNSCREEN SPF 30 (ZINC OXIDE 13.5%) CREAM [COOLA LLC]12 package rows20230410_6a1de324-c67d-4698-9fd9-f55858df38d1.zip

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79753-07879753-078-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
ALOE VERA LEAFZY81Z83H0XIACT
COCONUT OILQ9L0O73W7LIACT
JOJOBA OIL724GKU717MIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
WATER059QF0KO0RIACT
OLIVE OIL POLYGLYCERYL-6 ESTERS4KDO9AFM9IIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
JASMINUM SAMBAC FLOWER2S686I937FIACT
COCOAD9108TZ9KGIACT
SCHINUS MOLLE FRUITING TOPT8L6O1KSB4IACT
NYMPHAEA CAERULEA FLOWERS9560USZ74IACT
PAEONIA LACTIFLORA FLOWERR73687A534IACT
NELUMBO NUCIFERA FLOWER61W322NLDVIACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S)Q7UI015FF9IACT
PROPANEDIOL5965N8W85TIACT
GLYCERINPDC6A3C0OXIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
POLYMETHYLSILSESQUIOXANE (11 MICRONS)Z570VEV8XKIACT
XANTHAN GUMTTV12P4NEEIACT
METHYLPROPANEDIOLN8F53B3R4RIACT
CAPRYLYL GLYCOL00YIU5438UIACT
POLYQUATERNIUM-803N8LGV97HRIACT
DIDECYLDIMONIUM CHLORIDEJXN40O9Y9BIACT

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
6ac723d3-9a33-44db-810b-f86f231c81076a1de324-c67d-4698-9fd9-f55858df38d12023-04-09WarningsExact identifier
spl id: 6ac723d3-9a33-44db-810b-f86f231c8107
spl set id: 6a1de324-c67d-4698-9fd9-f55858df38d1

Reported adverse events (FAERS/openFDA)#

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