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 317 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Slip Tint Broad Spectrum SPF 35 Tinted MoisturizerZINC OXIDEClean Beauty For All, Incccf9daf4-0bf0-2610-e053-2a95a90a3f072023-12-12WarningsExact identifier
application number: M020
MINERAL BODY SUNSCREEN UNSCENTEDZINC OXIDESynchronicity Spa, Inc. DBA Suntegrity17cb6a73-5bfe-4227-ab9f-f6dd90bac2662023-12-12WarningsExact identifier
application number: M020
Vichy Laboratoires Capital Soleil 60 Mineral Sunscreen Broad Spectrum SPF 60 Water Resistant 80 Minutes Sheer Tint Ultra LightweightTITANIUM DIOXIDELOreal USA Products Inc4692b146-1abe-48e8-b097-ea9c556962b62023-12-11WarningsExact identifier
application number: M020
Vichy Laboratories LiftActiv Peptide-C SPF 30 Phyto Peptides Vitamin CAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc40fd5146-f4f0-4c2d-a786-d18f8ade1bef2023-12-11WarningsExact identifier
application number: M020
Vichy Laboratories LiftActiv Peptide-C SPF 30 Sunscreen Phyto Peptides Vitamin CAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENECosmetique Active Productsf5b3e52e-64f7-4e97-ba74-60de904b87712023-12-11WarningsExact identifier
application number: M020
Vichy Laboratoires Capital Soleil 60 Mineral Broad Spectrum SPF 60 Water Resistant 80 Minutes Sheer Tint Ultra Lightweight SunscreenTITANIUM DIOXIDECosmetique Active Productionacb887bc-7e46-4257-9fe3-a2cade6c4f382023-12-11WarningsExact identifier
application number: M020
Solar Defense BodyAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEHydroPeptide LLC45ec77c5-5eb3-0e51-e054-00144ff8d46c2023-12-09WarningsExact identifier
application number: M020
Erborian BB creme au Ginseng chocolate SPF 20OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&Lddcd6ea4-e7b1-88df-e053-2a95a90a99232023-12-09WarningsExact identifier
application number: M020
ERBORIAN - BB CREME AU GINSENG CARAMEL SPF20OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L43c81760-6bb6-25fe-e054-00144ff8d46c2023-12-09WarningsExact identifier
application number: M020
Erborian CC Dull Correct SPF25OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&Lcb23ba95-1e83-4523-a35c-3b70c0605dd12023-12-09WarningsExact identifier
application number: M020
Carmex Classic Lip Balm Medicated Free Wintergreen StickOCTINOXATE, OXYBENZONE, CAMPHOR (SYNTHETIC), WHITE PETROLATUMCarma Laboratories, Inc.bc0162bc-92ca-ee78-e053-2a95a90a7c9d2023-12-08WarningsExact identifier
application number: M020
Raw Elements Eco Formula SPF30 Sample PacksZINC OXIDERaw Elements LLC9e91e228-0b5e-4577-9d57-cdb9e9a705e82023-12-08WarningsExact identifier
application number: M020
Multi-Active Jour SPF 20 Broad Spectrum SunscreenAVOBENZONE,HOMOSALATE,OCTOCRYLENELaboratoires Clarins432f07e8-6f0f-4946-b1b6-4559ef1af5612023-12-08WarningsExact identifier
application number: M020
CLARINS - EXTRA-FIRMING JOUR SPF 15 - Wrinkle, Firming Day all skin types - Broad Spectrum SPF 15 SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENELaboratoires Clarinsae34fdcb-d372-435f-bf7c-075ea554b2fe2023-12-08WarningsExact identifier
application number: M020
UV ESSENTIEL COMPLETE UV PROTECTION SUNSCREEN ANTIOXIDANT ANTI-POLLUTION BROAD SPECTRUM SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENECHANEL PARFUMS BEAUTEdf2a43b4-eab9-48cd-a4b6-d00cfc9254772023-12-08WarningsExact identifier
application number: M020
SERIOUS SKINCARE SERIOUS-C3 PLASMA TM BIO TECHNOLOGY C VITAMIN C ESTER PROTECTIVE DAYTIME BROAD SPECTRUM MOISTURIZER SPF 30AVOBENZONE, OCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONEFlageoli Limited4833b0b1-33b7-59d4-e054-00144ff8d46c2023-12-07WarningsExact identifier
application number: M020
Cetaphil Sheer Mineral Sunscreen SPF 30TITANIUM DIOXIDE, ZINC OXIDEGalderma Laboratories, L.P.ac2d5713-9955-477e-a10f-e8a1191b5fdd2023-12-07WarningsExact identifier
application number: M020
CLARINS BROAD SPECTRUM SPF 50 Sunscreen BodyAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE,Laboratoires Clarins7feb0679-6557-4917-a386-7ce2c14a94e22023-12-06WarningsExact identifier
application number: M020
CLARINS BROAD SPECTRUM SPF 50 Dry Touch Facial SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONELaboratoires Clarins5bddb1d6-2493-41bf-8c14-73f103c55aa72023-12-05WarningsExact identifier
application number: M020
Sea Clearly Hydrating Facial SPF 35 KinetinOCTOCRYLENE, OCTISALATE,HOMOSALAT, AVOBENZONEAllure Labs0bc829ff-34a0-03e9-e063-6294a90a10ae2023-12-05WarningsExact 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