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 108 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Avail Facial Sunscreen SPF 25HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEEmeis Cosmetics Pty Ltd7be903e4-5f07-35b2-e053-2991aa0a13402025-12-17WarningsExact identifier
application number: M020
Mineral Sheer StickZINC OXIDESupergoop, LLC0beed72e-51df-d15a-e063-6394a90af5592025-12-17WarningsExact identifier
application number: M020
Sunscreen Lotion118mlZINC OXIDE 12%,TITANIUM DIOXIDE 6%, HOMOSALATE 14%,OCTISALATE 5%Foshan Sugar Max Cosmetics CO.,Ltd4620c41a-2188-00f5-e063-6394a90a613c2025-12-17WarningsExact identifier
application number: M020
Sunscreen CreamZINC OXIDE 15%,TITANIUM DIOXIDE 6%,HOMOSALATE 5%,OCTISALATE 4%Foshan Sugar Max Cosmetics CO.,Ltd46224dbe-a0fb-c242-e063-6394a90a26342025-12-17WarningsExact identifier
application number: M020
CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 0NENSULIZOLE, OCTISALATEParfums Christian Dior31141a45-54e2-4463-ab42-4df56d9116502025-12-17WarningsExact identifier
application number: M020
Perricone High Potency Face Finishing and Firming MoisturizerTITANIUM DIOXIDE, ZINC OXIDETHG Beauty USA LLC2409cea1-7077-dc12-e063-6294a90a45582025-12-17WarningsExact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEGlow Advanced Skin and Body Care, LLC3635a073-5484-f96c-e063-6394a90adef52025-12-17Exact identifier
application number: M020
Mineral Sunscreen LipTITANIUM DIOXIDE, ZINC OXIDEGlow Advanced Skin and Body Care, LLC36362dc7-31d7-f766-e063-6294a90a129b2025-12-17Exact identifier
application number: M020
Mineral Sunscreen Non-TintedZINC OXIDEGlow Advanced Skin and Body Care, LLC3635e45b-6978-ac69-e063-6294a90a22ac2025-12-17Exact identifier
application number: M020
Prime and ProtectTITANIUM DIOXIDE, ZINC OXIDEShannon Cornelsen-Lewandowski36480f7f-37e8-decd-e063-6394a90ada602025-12-17Exact identifier
application number: M020
Prime and ProtectTITANIUM DIOXIDE, ZINC OXIDEShannon Cornelsen-Lewandowski364827bd-5781-eb53-e063-6394a90ab22f2025-12-17Exact identifier
application number: M020
non-tinted face mineral sunscreen SPF40TITANIUM DIOXIDE, ZINC OXIDELisa Nadler Skin Care and Waxing3649bf1a-17c3-fe0b-e063-6294a90a13c02025-12-17Exact identifier
application number: M020
Tinted Mattifying Face Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDELisa Nadler Skin Care and Waxing3649f634-8bcd-b3c1-e063-6394a90a49d92025-12-17Exact identifier
application number: M020
tinted face and body mineral sunscreen SPF40ZINC OXIDELisa Nadler Skin Care and Waxing364a1edd-56e1-55f0-e063-6294a90a45a62025-12-17Exact identifier
application number: M020
non-tinted face and body mineral sunscreen SPF40ZINC OXIDELisa Nadler Skin Care and Waxing364a8c8d-df84-e568-e063-6394a90aaff12025-12-17Exact identifier
application number: M020
tinted lip mineral sunscreen SPF45TITANIUM DIOXIDE, ZINC OXIDELisa Nadler Skin Care and Waxing364b023b-4a52-225a-e063-6394a90ad1972025-12-17Exact identifier
application number: M020
ULTAMATTE PROTECTION SUNSCREENTITANIUM DIOXIDE, ZINC OXIDESKINFINITY37efc466-17b8-9f7b-e063-6294a90a8c882025-12-17Exact identifier
application number: M020
ULTRA SILK PROTECTION SUNSCREENZINC OXIDESKINFINITY383ea760-d55e-a32a-e063-6294a90aa3d22025-12-17Exact identifier
application number: M020
Bella Blu Skin Care Non Tinted SunscreenZINC OXIDEBELLA BLU STUDIOS INC3f67134c-88e8-8513-e063-6294a90aaf5a2025-12-17WarningsExact identifier
application number: M020
Bella Blu Skin Care Non Tinted SunscreenZINC OXIDEBELLA BLU STUDIOS INC3f66d2ae-00e7-608c-e063-6294a90a49c62025-12-17WarningsExact 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