FDA.reportPublic FDA data

COOLA Firming Face Serum Sunscreen

Manufacturer
COOLA LLC | Bentley Laboratories, LLC
Effective date
2025-03-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:56:51

Label at a glance#

ProductCOOLA Firming Face Serum Sunscreen SPF 30
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

AVOBENZONE 3%, HOMOSALATE 5%, OCTISALATE 5%, OCTOCRYLENE 10%

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 aging caused by the sun

WARNINGS SECTION

Warnings

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

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

● Apply liberally 15 minutes before sun exposure

● Reapply at least every 2 hours

● Use a water resistant sunscreen especially if swimming or sweating

● 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-sleve shirts, pants, hats, and sunglasses

   ● Children under 6 months: Ask a doctor

INACTIVE INGREDIENT SECTION

Inactive Ingredients
Caprylic/Capric Triglyceride(ORGANIC), Helianthus Annuus
(Sunflower) Seed Oil (ORGANIC), Ethylhexyl Methoxycrylene,
Maleated Soybean Oil Glyceryl/Octyldodecanol Esters
(ORGANIC), Tetrahexyldecyl Ascorbate, Bakuchiol, Moringa
Oleifera Seed Oil (ORGANIC), Simmondsia Chinensis
(Jojoba) Seed Oil (ORGANIC), Carthamus Tinctorius
(Safflower) Seed Oil, Hippophae Rhamnoides Fruit Oil, Alaria
Esculenta Extract, Rosmarinus Officinalis (Rosemary) Leaf
Extract, Citrullus Lanatus (Watermelon) Seed Oil, Tagetes
Erecta Flower Extract, 1,2-Hexanediol, Tocopheryl Acetate,
Terpineol, Fragrance* (Natural)

OTHER SAFETY INFORMATION

Other Information

● Protect this product from excessive heat and direct sun

OTC - QUESTIONS SECTION

Questions or comments? Call 760-940-2125

-------------------

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product Labeling - COOLA Firming Face Oil Sunscreen SPF 30

COOLA Firming Face Oil

Sunscreen

Broad Spectrum  SPF 30

1.1 FL OZ / 33 mL

2024 COOLA.

Manufactured in the USA for

COOLA LLC, located in Sunny

San Diego, CA 92009.

All Rights Reserved.

www.coola.com

33 mL Carton

083 01 Cartn083 01 Cartn

33 mLBottle

083-01 Bottle083-01 Bottle083-01 Bottle083-01 Bottle

5 mL Sample Card

083 Sample Card083 Sample Card

5 mL Sample Bottle

083 Sample Botl083 Sample Botl

res

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79753-083-01COOLA Firming Face Serum SunscreenSPF 301 in 1 CARTONOIL11
79753-083-01COOLA Firming Face Serum SunscreenSPF 3033 mL in 1 BOTTLE, DROPPEROIL331
79753-083-02COOLA Firming Face Serum SunscreenSPF 305 mL in 1 BOTTLE, DROPPEROIL51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79753-083COOLA FIRMING FACE SERUM SUNSCREEN SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE SUNSCREEN SERUM) OIL [COOLA LLC]1Current NDC, 3 package rows20250309_85fd7ef4-ed08-4a69-8293-5f3f3d264c04.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
79753-08379753-083-01, 79753-083-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL3W1JG795YIIACT
ETHYLHEXYL METHOXYCRYLENES3KFG6Q5X8IACT
SOYBEAN OIL241ATL177AIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
BAKUCHIOLOT12HJU3ARIACT
MORINGA OLEIFERA SEED OILREM6A5QMC0IACT
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL724GKU717MIACT
CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL65UEH262ISIACT
HIPPOPHAE RHAMNOIDES FRUIT OILTA4JCF9S1JIACT
ALARIA ESCULENTAEJ9JK8J58DIACT
ROSEMARYIJ67X351P9IACT
Citrullus Lanatus (Watermelon) Seed OilL33J06UQTTIACT
TAGETES ERECTA FLOWERUH5X33P33EIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TERPINEOLR53Q4ZWC99IACT

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 Firming Face Serum Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE SUNSCREEN SERUMCOOLA LLC85fd7ef4-ed08-4a69-8293-5f3f3d264c042025-03-06WarningsExact identifier
ndc (package): 79753-083-01
ndc (package): 79753-083-02
ndc (product): 79753-083
ndc11 (package): 79753008302
ndc11 (package): 79753008301
spl id: fed37d4f-f78b-4478-9d57-35dce2ae34d6
spl set id: 85fd7ef4-ed08-4a69-8293-5f3f3d264c04

Reported adverse events (FAERS/openFDA)#

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