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 238 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
glo SKIN BEAUTY Moisturizing Tint SPF 30GLO SKIN BEAUTY MOISTURIZING TINT SPF 30Hayden Caleel LLC2b464a70-8f40-3148-e063-6394a90ac18c2025-01-09WarningsExact identifier
application number: M020
Sunscreen and insect repellent Bull frogSPF 50Bullfrog Brands, LLCd65d15a6-0a32-1203-e053-2995a90aa6c52025-01-09WarningsExact identifier
application number: M020
Sunscreen and insect repellent Bull frogSPF 50Bullfrog Brands, LLCd5fb3632-24da-2c7a-e053-2a95a90a50812025-01-09WarningsExact identifier
application number: M020
Protect Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDENEW SEASON DERMATOLOGY, PLLCfecd72a3-c7e5-3dfa-e053-6394a90a73572025-01-09WarningsExact identifier
application number: M020
ERBORIAN DOUBLE SAMPLE CC CREME CLAIR and DORE SPF 25OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L41b3cf18-dc11-4e1d-802e-5ba25bd87adb2025-01-09WarningsExact identifier
application number: M020
ECLIPSE SPF 50 PERFECTINT BEIGETITANIUM DIOXIDE, ZINC OXIDESCIENCE OF SKINCARE LLCb69dda25-372f-15d9-e053-2995a90a8d3e2025-01-09WarningsExact identifier
application number: M020
PerfecTint Powder SPF 40 All ShadesZINC OXIDEScience of Skincarebb26c010-299e-3dc5-e053-2995a90a2c892025-01-09WarningsExact identifier
application number: M020
Extreme Protect SPF 40 All ShadesZINC OXIDE, TITANIUM DIOXIDEScience of Skincare, LLC.b69db78b-5f0e-8ca2-e053-2a95a90ac88c2025-01-09WarningsExact identifier
application number: M020
ECLIPSE SPF 50 ALL SHADESTITANIUM DIOXIDE, ZINC OXIDESCIENCE OF SKINCARE LLC49df51e6-be9a-41be-b3e1-bfc062aaceaa2025-01-09WarningsExact identifier
application number: M020
CoTZ Mineral Suns Stick - Tinted SPF 45TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD44a6ff9b-8067-4f32-acb2-4ede54c79e6e2025-01-09WarningsExact identifier
application number: M020
NUDESCREEN BLUSH TINT SPF 30 - SUNKISSEDZINC OXIDE SUNSCREENBentley Laboratories, LLCc45b59d8-0196-4dce-bfaa-57c47f655fe82025-01-09WarningsExact identifier
application number: M020
TiZO Tinted Lip Protection SPF 45TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD81ee1b28-c7d7-4b34-b0f0-5a3cc7a139a22025-01-09WarningsExact identifier
application number: M020
CoTZ Face Prime and Protect SPF 40 (Tinted)TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD1088fbf6-5790-490d-b272-ec281b4b76fa2025-01-09WarningsExact identifier
application number: M020
CoTZ Face Prime and Protect SPF 40 (Non-Tinted)TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTDf106f52b-2157-46c7-9f7c-50f43a6490502025-01-09WarningsExact identifier
application number: M020
NUDESCREEN BLUSH TINT SPF 30 - SUNNY SWEET CHEEKSZINC OXIDE SUNSCREENBentley Laboratories, LLC5c98bacb-8bbd-47b8-8987-50be1ed34fc02025-01-09WarningsExact identifier
application number: M020
CoTZ Face MoistureZINC OXIDEFallien Cosmeceuticals, LTDdb682516-6c8f-4009-a9ec-e21dfc64ce152025-01-09WarningsExact identifier
application number: M020
L Bri CC DD Color Correcting Daily Defense Sunscreen SPF 30 Light MediumOCTOCRYLENE, ZINC OXIDEL'BRI Health & Beautybcd22c9a-2db6-4653-9ab5-825f3f5cc4202025-01-08WarningsExact identifier
application number: M020
L Bri CC DD Color Correcting Daily Defense Sunscreen SPF 30 LightOCTOCRYLENE, ZINC OXIDEL'BRI Health & Beautyc66c2a54-97c8-4904-a44a-b3cf790837f52025-01-08WarningsExact identifier
application number: M020
Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATETempo Industries, Inc.af9aa56d-2f8a-55b9-e053-2a95a90a32582025-01-08WarningsExact identifier
application number: M020
Baby Mineral Sunscreen Probiotics SPF55ZINC OXIDEHello Bello0191b2e4-bcc5-541a-e063-6294a90a0e782025-01-08WarningsExact 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