FDA.reportPublic FDA data

COOLA Full Spectrum 360 Refreshing Water Cream SPF 50

Product NDC
79753-020
11-digit product format
797530020
Labeler code
79753
Product ID
79753-020_1cc9aa13-9722-40c4-b356-c18a20fd432d
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Dosage form
CREAM
Route
TOPICAL
Labeler
COOLA LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-02-08
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
3; 5; 3; 5 g/100mL; g/100mL; g/100mL; g/100mL
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 Full Spectrum 360 Refreshing Water Cream SPF 50
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE3 g/100mL
HOMOSALATE5 g/100mL
OCTISALATE3 g/100mL
OCTOCRYLENE5 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d12e30bd-88ee-4e34-ae63-c34766aed3a8Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79753-020-01COOLA Full Spectrum 360 Refreshing Water Cream SPF 501 in 1 CARTONCREAM12
79753-020-01COOLA Full Spectrum 360 Refreshing Water Cream SPF 5044 mL in 1 JARCREAM442
79753-020-02COOLA Full Spectrum 360 Refreshing Water Cream SPF 5015 mL in 1 JARCREAM152
79753-020-02COOLA Full Spectrum 360 Refreshing Water Cream SPF 501 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79753-020COOLA FULL SPECTRUM 360 REFRESHING WATER CREAM SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) CREAM [COOLA LLC]2Current NDC, Legacy NDC, 4 package rows20231221_d12e30bd-88ee-4e34-ae63-c34766aed3a8.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 105 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 4WPOCTISALATE, TITANIUM DIOXIDEParfums Christian Diora8037741-ec57-43e7-adb4-2a93941ee1082025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 4WOOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior6f872199-067e-40aa-bf34-549ecc33b1ac2025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 4WOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior4f27a485-1e8b-4f34-99a8-0d0a3cf1b9db2025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 4NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior938a5c4a-b9dd-4089-8b20-7030f032591d2025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 4COCTISALATE, TITANIUM DIOXIDEParfums Christian Dior1357ab72-0d73-41da-8f55-7bd6d97c9ae82025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 4.5WOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior2d63bdc5-5338-48c4-9c59-bfb9900ab9202025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 4.5NOCTISALATE, TITANIUM DIOXIDEParfums Christian Diora315ed9c-bc19-40e9-85ab-50ac1daa54492025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 3WPOCTISALATE, TITANIUM DIOXIDEParfums Christian Diora63ea887-cbe0-4a04-ad62-4d3a87ece1132025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 3WOOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior15c50e40-b97d-4612-a533-cf9d1d57b4172025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 3WOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior63711abf-e906-4c07-bc2d-f8e10fead2f02025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 3NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior21455f0c-0190-4519-a8e3-34206d1f7a422025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 3CROCTISALATE, TITANIUM DIOXIDEParfums Christian Dior3894273d-c5e7-4ea8-9956-5ac3d88b74202025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 3COCTISALATE, TITANIUM DIOXIDEParfums Christian Dior8b63133c-150a-4290-a7fb-56b0dc42a8ce2025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 3.5NOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorae7ca27f-7806-452e-9935-4a4abc37a5eb2025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 2WPOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior9bbacc16-8d60-4170-a3cb-0bfb748177a22025-12-19WarningsExact identifier
application number: M020
Perricone MD NEUROPEPTIDE Rejuvenating Moisturizer SPF 25 Broad Spectrum SPF 25ZINC OXIDETHG Beauty USA LLC464e2d4e-9837-e6d5-e063-6294a90a726a2025-12-19WarningsExact identifier
application number: M020
YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 FAIRTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLC4327c775-e179-47d8-9b4b-945fc1b0b2342025-12-19WarningsExact identifier
application number: M020
YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 LIGHTTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLC0f3a9b6a-b1b2-4d69-88de-6f22c17a48442025-12-19WarningsExact identifier
application number: M020
YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 TANTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLC5cce7646-d9f5-454b-b7a8-a5a6b62a19162025-12-19WarningsExact identifier
application number: M020
YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 RICHTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLC7da16dd7-c26c-4c4e-905f-3bbb878022cc2025-12-19WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
79753-020-01797530020011 JAR in 1 CARTON (79753-020-01) / 44 mL in 1 JAR1 jar2021-02-080000-00-00NoNoCurrent
79753-020-02797530020021 JAR in 1 CARTON (79753-020-02) / 15 mL in 1 JAR1 jar2021-02-080000-00-00NoNoCurrent