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 255 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BabyGanics Sunscreen 30 SPFZINC OXIDE, OCTINOXATE, AND OCTISALATEKAS Direct LLC dba BabyGanics391a4ec3-b65b-4dbe-bc8f-cb67514c8ef12024-12-19WarningsExact identifier
application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 PORCELAINOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC299ac9a5-f609-d804-e063-6394a90abd052024-12-19WarningsExact identifier
application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 IVORYOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC299ad424-16a8-66b1-e063-6394a90a07532024-12-19WarningsExact identifier
application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 NUDEOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC299afef9-758f-74e1-e063-6294a90a80722024-12-19WarningsExact identifier
application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 NATURAL BEIGEOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC299b3276-7973-d33f-e063-6294a90a6ce12024-12-19WarningsExact identifier
application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 CLASSIC TANOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC299afe24-d496-5745-e063-6394a90aa1b32024-12-19WarningsExact identifier
application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 WARM BEIGEOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC299b1f9a-34fd-cb50-e063-6394a90af9252024-12-19WarningsExact identifier
application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 SOFT SANDOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC299b3236-3f3d-c9e8-e063-6394a90a74432024-12-19WarningsExact identifier
application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 TAWNYOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC299b416d-ce02-3462-e063-6294a90a38f02024-12-19WarningsExact identifier
application number: M020
PuttisuTITANIUM DIOXIDE, ZINC OXIDEJellycup, Inc.a032331a-6724-d2cd-e053-2995a90ac15a2024-12-19WarningsExact identifier
application number: M020
Dr. C. Tuna Resurface Essential Day Cream SPF 30HOMOSALATE, OCTINOXATE, OCTOCRYLENE, AVOBENZONEFarmasi US LLCde493e30-d135-9def-e053-2995a90ae49a2024-12-19WarningsExact identifier
application number: M020
toty Ilumina CC Cream 1NTITANIUM DIOXIDE, ZINC OXIDEChipican LLCe4efe14e-7d46-78c0-e053-2995a90a23642024-12-19WarningsExact identifier
application number: M020
Aruba Sun SPF 50 SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Derma Care Research Labs, LLCd8b28ce6-e938-c6e3-e053-2a95a90acc292024-12-19WarningsExact identifier
application number: M020
DCH Pain Relief Roll-OnLIDOCAINE HCL 4%Derma Care Research Labs, LLCfda35d37-f36e-efc8-e053-6294a90a2bb82024-12-19WarningsExact identifier
application number: M020
Black Girl Sunscreen SPF 50 KidsAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Derma Care Research Labs, LLCd53ff8f5-0b06-1e8b-e053-2a95a90ab9242024-12-19WarningsExact identifier
application number: M020
Fresh Coast SPF 50 SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Derma Care Research Labs, LLC043cadde-ba07-7c77-e063-6394a90abee62024-12-19WarningsExact identifier
application number: M020
Black Girl Sunscreen SPF 30AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 8%Derma Care Research Labs, LLCd438be95-0f88-69d7-e053-2995a90a982e2024-12-19WarningsExact identifier
application number: M020
Pavin SPF 50 SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Derma Care Research Labs, LLCe945f9df-0aed-469c-e053-2995a90ab6aa2024-12-19WarningsExact identifier
application number: M020
Bee Bald Smooth Plus Daily Moisturizer SPF 30 SunscreenAVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 2.7%, OXYBENZONE 6%Derma Care Research Labs, LLC051b68f9-5d6b-3cd7-e063-6394a90aeb352024-12-19WarningsExact identifier
application number: M020
MKMen Advanced Facial Hydrator Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEMary Kay Inc.484e92db-09a2-4e93-aa7e-d91dbda315552024-12-19WarningsExact 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