FDA.reportPublic FDA data

COOLA CLASSIC BODY SUNSCREEN Guava Mango Broad Spectrum

Product NDC
79753-075
11-digit product format
797530075
Labeler code
79753
Product ID
79753-075_51a93370-03f8-4573-9b72-0fbdf00cf4bf
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE
Dosage form
LOTION
Route
TOPICAL
Labeler
COOLA LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-02-01
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
1.75; 5; 2; 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 CLASSIC BODY SUNSCREEN Guava Mango Broad Spectrum
Brand name suffix
SPF 50
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE1.75 g/100mL
HOMOSALATE5 g/100mL
OCTISALATE2 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
9a397a2c-4734-4dae-93dd-15c68e6c297dAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79753-075-02COOLA CLASSIC BODY SUNSCREEN Guava Mango Broad SpectrumSPF 50100 mL in 1 TUBELOTION1003
79753-075-02COOLA CLASSIC BODY SUNSCREEN Guava Mango Broad SpectrumSPF 501 in 1 CARTONLOTION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79753-075COOLA CLASSIC BODY SUNSCREEN GUAVA MANGO BROAD SPECTRUM SPF 50 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE) LOTION [COOLA LLC]3Current NDC, 2 package rows20241228_9a397a2c-4734-4dae-93dd-15c68e6c297d.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 189 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dolce and Gabbana Blueberry Nutri Tint SPF 20 2C LightZINC OXIDEDolce & Gabbana Beauty S.R.L761ce50c-2bf5-4ed0-91ac-9c47f8790ddb2025-09-05WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 3W LightZINC OXIDEDolce & Gabbana Beauty S.R.L2781b921-eb0d-4270-addf-47301577b28c2025-09-05WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 5N LightZINC OXIDEDolce & Gabbana Beauty S.R.L893434a1-72b8-4f0f-bfaa-2c9d775d7e272025-09-05WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 7N LightZINC OXIDEDolce & Gabbana Beauty S.R.L199d97a2-d32b-45ab-a43d-30522b0ca5962025-09-05WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 10N Light MediumZINC OXIDEDolce & Gabbana Beauty S.R.L638eafb5-08a8-425f-893f-d6609b868e2b2025-09-05WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 9C Light MediumZINC OXIDEDolce & Gabbana Beauty S.R.L41fd80a9-2c6f-4f3e-a37d-e781965ddc552025-09-05WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 11W Light MediumZINC OXIDEDolce & Gabbana Beauty S.R.L50bac9fb-5b81-4cdd-9eae-ec9530fc46c32025-09-05WarningsExact identifier
application number: M020
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
Daily Body Moisturizer Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBaxter Laboratories Pty. Ltd.3e115ef1-f039-4c72-e063-6394a90a7e642025-09-05WarningsExact 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
79753-075-02797530075021 TUBE in 1 CARTON (79753-075-02) / 100 mL in 1 TUBE1 tube2023-02-01NoNoCurrent