Home NDC 79753-059 COOLA Classic Body SPF 50 Guava Mango
Product NDC 79753-059
11-digit product format 797530059
Labeler code 79753
Product ID 79753-059_2e21acbd-4362-923b-e063-6394a90a3269
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form SPRAY
Route TOPICAL
Labeler COOLA, LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-10-01
Substance AVOBENZONE; OCTISALATE; OCTOCRYLENE; HOMOSALATE
Active strength 2.9; 4.9; 9.5; 4 g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 27 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 SPF 50 Guava Mango
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 2.9 g/100mL OCTISALATE 4.9 g/100mL OCTOCRYLENE 9.5 g/100mL HOMOSALATE 4 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 79753-059-01 COOLA Classic Body SPF 50 Guava Mango 177 mL in 1 CAN SPRAY 177 3 79753-059-02 COOLA Classic Body SPF 50 Guava Mango 60 mL in 1 CAN SPRAY 60 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 79753-059 COOLA CLASSIC BODY SPF 50 GUAVA MANGO (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) SPRAY [COOLA, LLC] 3 Current NDC, Legacy NDC, 2 package rows 20250216_ed13afaa-35ec-8326-e053-2995a90adaf0.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 352 of 352 · 7,030 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Amber OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE BCM Cosmetique SAS 7f5e6872-4d26-410e-8afe-16a016f9a399 2019-10-08 Warnings Exact identifier application number: M020 No7 Perfect and Perfect Advanced All in One Foundation SPF 50 Warm Ivory OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE BCM Cosmetique SAS 1124ba7d-a328-409b-8c88-e74bb3e501f5 2019-10-08 Warnings Exact identifier application number: M020 No7 Perfect and Perfect Advanced All in One Foundation SPF 50 Honey OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE BCM Cosmetique SAS 9c407dc7-fcde-4660-9a06-57bd8a6b867d 2019-10-08 Warnings Exact identifier application number: M020 No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Chestnut OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE BCM Cosmetique SAS f07e8bb2-30ae-4337-ad60-84f55f2ff354 2019-10-08 Warnings Exact identifier application number: M020 Thinkbaby Sunscreen SPF 30 ZINC OXIDE thinkOperations,LLC 86249f33-e635-4455-a039-3a25aa3478df 2019-03-25 Warnings Exact identifier application number: M020 Sun Defense Mineral Sunscreen SPF 30 Face ZINC OXIDE derma e 635ae850-7ce4-4cb7-bdaf-bec00904ca02 2018-11-12 Warnings Exact identifier application number: M020 Thinksport Sunscreen SPF 30 ZINC OXIDE thinkOperations,LLC a8591509-65f7-4e62-8642-4b8e63f1fef3 2018-11-08 Warnings Exact identifier application number: M020 Essential Defense Everyday Clear Broad Spectrum SPF 47 Sunscreen ZINC OXIDE AND OCTINOXATE Allergan, Inc. bc872876-20e7-40cb-b79d-68998883681a 2016-03-01 Warnings Exact identifier application number: M020 TOTAL DEFENSE REPAIR BROAD SPECTRUM SPF 34 Sunscreen (Tinted) OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE AND ZINC OXIDE Allergan, Inc. 6a996e03-907f-4e6a-b232-0892b86956b0 2015-08-21 Warnings Exact identifier application number: M020 TiZO2 TITANIUM DIOXIDE, ZINC OXIDE Fallien Cosmeceuticals, LTD. 30468afc-9616-4765-b046-12e97a0a7827 2010-12-20 Warnings Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 79753-059-01 79753005901 177 mL in 1 CAN (79753-059-01) 177 ml 2019-10-01 0000-00-00 No No Current 79753-059-02 79753005902 60 mL in 1 CAN (79753-059-02) 60 ml 2020-02-01 0000-00-00 No No Current