FDA.reportPublic FDA data

COOLA CLASSIC SUNSCREEN FRAGRANCE FREE

Product NDC
79753-045
11-digit product format
797530045
Labeler code
79753
Product ID
79753-045_45ede361-ecc1-0474-e063-6294a90a9c2d
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form
LOTION
Route
TOPICAL
Labeler
COOLA, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-01-01
Substance
HOMOSALATE; AVOBENZONE; OCTOCRYLENE; OCTISALATE
Active strength
100; 30; 80; 45 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
COOLA CLASSIC SUNSCREEN FRAGRANCE FREE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE100 mg/mL
AVOBENZONE30 mg/mL
OCTOCRYLENE80 mg/mL
OCTISALATE45 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V06SV4M95SInternal UNII lookup
G63QQF2NOXInternal UNII lookup
5A68WGF6WMInternal UNII lookup
4X49Y0596WInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
cfc21b1a-4a26-1573-e053-2995a90a2d50Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79753-045-72COOLA CLASSIC SUNSCREEN FRAGRANCE FREE946 mL in 1 BOTTLELOTION9464

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79753-045COOLA CLASSIC SUNSCREEN FRAGRANCE FREE (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [COOLA, LLC]3Current NDC, Legacy NDC, 1 package rows20241025_cfc21b1a-4a26-1573-e053-2995a90a2d50.zip

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 325 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Spit and Polish Mineral Lip Balm Broad Spectrum Lip Protectant SPF 30ZINC OXIDENaturally Uncommon, LLCaf882b7e-c64f-0de6-e053-2995a90a7ca02023-11-09WarningsExact identifier
application number: M020
EltaMD UV AOX MistZINC OXIDE SUNSCREENCP Skin Health Group, Inc1062efb1-a638-4323-88f8-f2f98a5b996e2023-11-09WarningsExact identifier
application number: M020
EltaMD UV ActiveZINC OXIDE, TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc.2c523aa0-7c34-4fc2-98a0-f2fdfe6d2cd22023-11-09WarningsExact identifier
application number: M020
Physical Sunscreen SPF50 80 min WR 159-100TITANIUM DIOXIDE, TITANIUM DIOXIDE SUNSCREENSwiss-American CDMO, LLC0cca7b65-e24a-429c-b157-5f4e343424ab2023-11-09WarningsExact identifier
application number: M020
Private Label Sunscreen SPF35 40min WR RE126-202HOMOSALATE, ZINC OXIDE SUNSCREENSwiss-American CDMO, LLC254fa69f-2413-47e8-bc9b-5b7b0b59a5c82023-11-09WarningsExact identifier
application number: M020
PLANTSCRIPTION SPF 25 POWER ANTI-AGING oil FREE BROAD SPECTRUMAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEORIGINS NATURAL RESOURCES INC.91c14980-ba63-4705-a465-581fe11d0a982023-11-08WarningsExact identifier
application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 0NOCTISALATE, TITANIUM DIOXIDEGuerlaina20dc51a-1f6c-4a6d-97f6-2f048e0689a02023-11-08WarningsExact identifier
application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 0.5COCTISALATE, TITANIUM DIOXIDEGuerlaina6c8b20f-6377-443b-a89b-8b5d40c65ad82023-11-08WarningsExact identifier
application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 0.5NOCTISALATE, TITANIUM DIOXIDEGuerlainb6591b2e-9e55-4f25-958c-f36f1ef857492023-11-08WarningsExact identifier
application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 1.5NOCTISALATE, TITANIUM DIOXIDEGuerlain6e2ae7cb-c390-4996-95e8-ae8fadefa8bd2023-11-08WarningsExact identifier
application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 1NOCTISALATE, TITANIUM DIOXIDEGuerlaina143c8cb-185c-4fd8-a901-3c0d9ffb82902023-11-08WarningsExact identifier
application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 1COCTISALATE, TITANIUM DIOXIDEGuerlain3d6e438d-9ea4-4253-9153-748d3c9742652023-11-08WarningsExact identifier
application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 2NOCTISALATE, TITANIUM DIOXIDEGuerlain173aeaab-a286-48ed-9033-10b13f547bbd2023-11-08WarningsExact identifier
application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 3.5NOCTISALATE, TITANIUM DIOXIDEGuerlaind877575a-25f3-49bd-b403-ecf6a1eb483a2023-11-08WarningsExact identifier
application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 5NOCTISALATE, TITANIUM DIOXIDEGuerlain24e1e576-9edd-45aa-a883-2a2d18a1cb5e2023-11-08WarningsExact identifier
application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 6NOCTISALATE, TITANIUM DIOXIDEGuerlaina8fffe38-5f90-4078-b553-30036659a2ee2023-11-08WarningsExact identifier
application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 7NOCTISALATE, TITANIUM DIOXIDEGuerlainbfa2b2be-958c-439f-b363-2623df2b85012023-11-08WarningsExact identifier
application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 3NOCTISALATE, TITANIUM DIOXIDEGuerlain15f73322-0b27-4412-b368-84bc768f55e82023-11-08WarningsExact identifier
application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 2WOCTISALATE, TITANIUM DIOXIDEGuerlain51392fe6-fbbb-4ea9-a7aa-98e1711eaa5d2023-11-08WarningsExact identifier
application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 4NOCTISALATE, TITANIUM DIOXIDEGuerlainb70b8ffc-091a-4969-86a7-6c3e1b9b9d742023-11-08WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
79753-045-7279753004572946 mL in 1 BOTTLE (79753-045-72) 946 ml2018-01-010000-00-00NoNoCurrent