FDA.reportPublic FDA data

COOLA Dew Good Illuminating Body Melt SPF 40

Product NDC
79753-082
11-digit product format
797530082
Labeler code
79753
Product ID
79753-082_569a1ea5-3c67-4296-92c7-af9621c809b0
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Octisalate, Octocrylene
Dosage form
CREAM
Route
TOPICAL
Labeler
COOLA LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-06-24
Substance
AVOBENZONE; OCTISALATE; OCTOCRYLENE
Active strength
3; 4; 8 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 Dew Good Illuminating Body Melt SPF 40
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE3 g/100mL
OCTISALATE4 g/100mL
OCTOCRYLENE8 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal 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
43d293f6-e13c-4ee9-89df-2a3ef0034e31Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79753-082-01COOLA Dew Good Illuminating Body Melt SPF 40100 mL in 1 TUBECREAM1003
79753-082-02COOLA Dew Good Illuminating Body Melt SPF 407 mL in 1 TUBECREAM73

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79753-082COOLA DEW GOOD ILLUMINATING BODY MELT SPF 40 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [COOLA LLC]3Current NDC, 2 package rows20240918_43d293f6-e13c-4ee9-89df-2a3ef0034e31.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 152 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Banana Boat Sport Ultra Broad Spectrum SPF 50 Plus Sunscreen Lip BalmAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCc7a3c03b-7fee-404c-e053-2a95a90a3a972025-12-04WarningsExact identifier
application number: M020
Poolside Bronze Service Instant bronzing lotion. SPF30HOMOSALATE,OCTOCRYLENE, OCTISALATE,OCTINOXATE, AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.4524129b-f8aa-171b-e063-6294a90aeebe2025-12-04WarningsExact identifier
application number: M020
Solbar Zinc SPF38SOLBAR ZINC SPF38Person and Coveyfac62a2f-92ee-4afd-9999-bc5011159e432025-12-04WarningsExact identifier
application number: M020
elf Sun Boss Gloss SPF 25 Sunscreen Pink Me GirlZINC OXIDEe.l.f. Cosmetics, Inc.6c316ce4-c2f6-4633-a789-e786d0f76abd2025-12-04WarningsExact identifier
application number: M020
Poolside Frostbite Sunscreen coconut SPF 15 Scented lip glossHOMOSALATE, OCTOCRYLENE, OCTISALATE , AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.452b5f2c-b61f-8915-e063-6294a90ac9112025-12-04WarningsExact identifier
application number: M020
Poolside Frostbite Sunscreen watermelon SPF 15 Scented lip glossHOMOSALATE , OCTOCRYLENE, OCTISALATE, AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.452b6e12-1bf9-8093-e063-6394a90a9e742025-12-04WarningsExact identifier
application number: M020
Poolside Frostbite Sunscreen Papaya SPF 15 Scented lip glossHOMOSALATE,OCTOCRYLENE,OCTISALATE,AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.452b6f22-5080-86ab-e063-6394a90a04162025-12-04WarningsExact identifier
application number: M020
Poolside Golden Hour SPF15 sunscreen lip oilHOMOSALATE,OCTOCRYLENE,OCTISALATE,AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.452b8393-1887-a660-e063-6394a90a4c2b2025-12-04WarningsExact identifier
application number: M020
Poolside Sun Daze Body Illuminator SPF 30 shimmer sunscreen gelHOMOSALATE,OCTOCRYLENE,OCTISALATE,AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.452b8dde-dd63-b585-e063-6394a90a35432025-12-04WarningsExact identifier
application number: M020
Binda Botanicals Baby and Kids Sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED452b9b7d-4049-b483-e063-6394a90a53582025-12-04WarningsExact identifier
application number: M020
BINDA Face and Body Sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED386f5013-430c-e07f-e063-6394a90a32a82025-12-04WarningsExact identifier
application number: M020
Poolside Not Your Babys Oil. SPF 30 sunscreen body oil.HOMOSALATE,OCTOCRYLENE,OCTISALATE,AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.452bcb25-848c-e8a7-e063-6394a90ace0f2025-12-04WarningsExact identifier
application number: M020
Sugargirl Glowy face screen sunbeam shimmer sunscreen for the face SPF 30HOMOSALATE, OCTOCRYLENE, OCTINOXATE, OCTISALATE, AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.452bd1d2-6a9f-f5e8-e063-6394a90ac9e32025-12-04WarningsExact identifier
application number: M020
Poolside Butter SCREEN SPF 30 sunscreen ButterHOMOSALATE , OCTOCRYLENE , OCTISALATE , AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.452bd24d-8654-e6c0-e063-6394a90a0aea2025-12-04WarningsExact identifier
application number: M020
Poolside Glow Butter Screen SPF 30 Shimmer sunscreen ButterHOMOSALATE , OCTOCRYLENE, OCTISALATE , AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.452bd69e-02c7-fcbd-e063-6394a90ae59b2025-12-04WarningsExact identifier
application number: M020
Softlips CherryDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Companybececc42-1321-430a-80ef-438060fdcc862025-12-04WarningsExact identifier
application number: M020
ATTITUDE Sunly Lip Balm SPF 15 WatermelonZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE450d038b-3f99-add8-e063-6294a90aee9a2025-12-03WarningsExact identifier
application number: M020
Natrience Broad Spectrum SPF 30SKIN SHIELDSisel International, LLC1989370f-68a6-6f22-e063-6394a90aacaf2025-12-03Boxed warning, WarningsExact identifier
application number: M020
ATTITUDE Super leaves Lip Balm SPF 15 CoconutZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE450d8fd0-20ad-1920-e063-6394a90a72712025-12-03WarningsExact identifier
application number: M020
ATTITUDE Super leaves Lip Balm SPF 15 ExoticZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE450db2bb-1788-efc2-e063-6294a90a13c02025-12-03WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
79753-082-0179753008201100 mL in 1 TUBE (79753-082-01) 100 ml2024-06-24NoNoCurrent
79753-082-02797530082027 mL in 1 TUBE (79753-082-02) 7 ml2024-06-24NoNoCurrent