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 188 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Jack Black L.L.C.AVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUMJack Black L.L.C.3e0eb291-6bda-2f26-e063-6294a90ac4662025-09-05WarningsExact identifier
application number: M020
Jack BlackAVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUMJack Black L.L.C.3d5fafb9-62c9-ec69-e063-6394a90af8b92025-09-05WarningsExact identifier
application number: M020
Jack BlackAVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUMJack Black L.L.C.3e0f655e-6100-f1dd-e063-6394a90af7b72025-09-05WarningsExact identifier
application number: M020
Truskin SPF 30 Mineral Sunscreen Facial SerumZINC OXIDEAllure Labs3e13299f-8d5d-373b-e063-6394a90ab2562025-09-05WarningsExact identifier
application number: M020
PowderTITANIUM DIOXIDEOxygen Development LLC08b52f29-c1a0-c673-e063-6294a90a9a7a2025-09-05WarningsExact identifier
application number: M020
PowderTITANIUM DIOXIDEOxygen Development LLC08b8003f-40be-3380-e063-6294a90a4f6b2025-09-05WarningsExact identifier
application number: M020
MAYDAY Everyday Sunscreen SPF 30ZINC OXIDEOmniche Consumer Products Co.3f53fb40-6347-46b0-979c-3522d99481982025-09-04WarningsExact identifier
application number: M020
PHOFAY Matte Sunscreen Liquid Foundation SPF 30, 1ENSULIZOLE, HOMOSALATE, OCTINOXATE, TITANIUM DIOXIDEHangzhou Jingshen Trading Co., Ltd.18130858-429c-4ed4-a75b-5bc0144812502025-09-04WarningsExact identifier
application number: M020
Introstem PrismaStem Face Shield CreamOCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE AND AVOBENZONEInnovation Brands Inc.dd91374a-e3fc-42f1-a660-86b32a0cc8b82025-09-04WarningsExact identifier
application number: M020
MEDICUBE COLLAGEN GLOW SUNSCREENHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEAPR US INC34fae072-536c-ad41-e063-6394a90af0af2025-09-03WarningsExact identifier
application number: M020
Basin Sugar Plum SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3de75cec-955e-4b3a-e063-6394a90a15432025-09-03WarningsExact identifier
application number: M020
Basin Mint SPF 30 Broad Spectrum Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONERetail Concepts of Minnesota, Inc.3de7d21b-4f88-d80c-e063-6394a90a8e4c2025-09-03WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 38C DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L0358a87d-8002-4f3e-851a-3a582d356edf2025-09-03WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 39N DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L34dfc4c5-44f7-4531-97ba-8846ebe147242025-09-03WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 40C DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lcf4b6f45-d4ae-4665-87b4-c5af4910befa2025-09-03WarningsExact identifier
application number: M020
DOLCE and GABBANA MEET YOUR FLAWLESS MATTE SKIN DUO - EVERLAST PRIMER EVERLAST FOUNDATIONOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDOLCE & GABBANA BEAUTY SRLeb63e9c6-bdb0-4bdf-8822-e4561a56adc92025-09-03WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 1N LightZINC OXIDEDolce & Gabbana Beauty S.R.L9507681c-236c-41c1-9dc9-ed4c0c0917412025-09-03WarningsExact identifier
application number: M020
Pure6 ManiShield Hand ScreenZINC OXIDE, TITANIUM DIOXIDEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD3abcb6ba-1de8-55e7-e063-6294a90aecf12025-09-02WarningsExact identifier
application number: M020
Round Lab Dodo s Pick Bestseller SetAVOBENZONE, HOMOSALATE, OCTISALATESEORIN COMPANY Co., Ltd.3dd3db99-2e9f-16fc-e063-6294a90adda12025-09-02WarningsExact identifier
application number: M020
Sun Bum Premium Sunscreen Face Stick Broad Spectrum SPF 30 Sunscreen - PeggedAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3d86da52-6354-f53e-e063-6394a90aac552025-09-02WarningsExact 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