FDA.reportPublic FDA data

Dew Good Illuminating Serum

Manufacturer
COOLA
Effective date
2021-12-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:47:52

Label at a glance#

ProductDew Good Illuminating Serum
Active ingredientAVOBENZONE, OCTISALATE, OCTOCRYLENE
Label structure14 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients
Avobenzone 3.0%, Octisalate 4.0%, Octocrylene 8.0%

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 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 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 skin aging. To
decrease this risk, regularly use a sunscreen with a broad
spectrum SPF of 15 or higher and after 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, Butolyctyl Salicylate,
Glycerin, Ammonium Acryloldimethyltaurate/VP
Copolymer, Bismuth Oxychloride, Lactobacillus
Ferment, Jasmine Sambach (Jasmine) Leaf Cell
Extract, Theodora Cacao (Cocoa) Seed Extract,
Schinus Molle Extract, Water, Titanium Dioxide, Ethyl
Ferulate, Tropolone, Mica, Hydroxyacetophenone,
Propanediol, Butylene Glycol, Sodium Stearoyl,
Glutamats, 1,2-Hexanediol, Caprylyl Glycol,
Ethylhexyl Hydroxystearate, Maltodextrin, Sodium
Phylate, 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

COOLA Dew Good Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SPF

30

70%

Organic

COOLA®

Dew Good

Illuminating Serum

Probiotic Sunscreen

1.15 FL OZ / 35 mL

Distributed by: COOLA LLC,

Locate at 6023 Innovation Way in

Sunny and Cool San Diego, CA 92009

www.coola.com

Carton

Dew Good CartnDew Good Cartn

Bottle

Dew Good BotlDew Good Botl

res

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79753-034-012023-01-30C16284748780-1f386c64a-30d9-0266-e053-dadaa90a7c1aCOOLA Dew Good Illuminating Serum Probiotic Sunscreen SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79753-034-01Dew Good Illuminating Serum1 in 1 CARTONLOTION11
79753-034-01Dew Good Illuminating Serum35 mL in 1 BOTTLELOTION351

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79753-034DEW GOOD ILLUMINATING SERUM (AVOBENZONE 3%, HOMOSALATE 4%, OCTOCRYLENE 8%) LOTION [COOLA]1Legacy NDC, 2 package rows20220201_cc7ae92d-613d-47a7-929f-d3d1dc3558b5.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
79753-03479753-034-01

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
AVOBENZONEG63QQF2NOXACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
ALOE VERA LEAFZY81Z83H0XIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
GLYCERINPDC6A3C0OXIACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERW59H9296ZGIACT
BISMUTH OXYCHLORIDE4ZR792I587IACT
LACTOBACILLUS FERMENTUM2C1F12C6APIACT
JASMINUM SAMBAC FLOWER2S686I937FIACT
COCOAD9108TZ9KGIACT
SCHINUS MOLLE FRUITING TOPT8L6O1KSB4IACT
WATER059QF0KO0RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ETHYL FERULATE5B8915UELWIACT
TROPOLONE7L6DL16P1TIACT
MICAV8A1AW0880IACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
PROPANEDIOL5965N8W85TIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
1,2-HEXANEDIOLTR046Y3K1GIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ETHYLHEXYL HYDROXYSTEARATEB7I80BVV5EIACT
MALTODEXTRIN7CVR7L4A2DIACT
PHYTATE SODIUM88496G1ERLIACT

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
3dee02e0-12f7-4f8d-aed0-01f0d3675931cc7ae92d-613d-47a7-929f-d3d1dc3558b52021-12-26WarningsExact identifier
spl id: 3dee02e0-12f7-4f8d-aed0-01f0d3675931
spl set id: cc7ae92d-613d-47a7-929f-d3d1dc3558b5

Reported adverse events (FAERS/openFDA)#

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