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 341 of 352 · 7,030 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Super Mint SPF 15 Broad Spectrum Lip Balm SUPER MINT SPF 15 BROAD SPECTRUM LIP BALM Raining Rose, Inc a9626a2f-9931-78d2-e053-2995a90ac40f 2023-10-23 Warnings Exact identifier application number: M020 Spearmint SPF 30 Broad Spectrum Lip Balm SPEARMINT SPF 30 BROAD SPECTRUM LIP BALM Raining Rose, Inc b7b520dc-bae6-614f-e053-2995a90ae677 2023-10-23 Warnings Exact identifier application number: M020 Citrus SPF 15 Broad Spectrum Lip Balm CITRUS SPF 15 BROAD SPECTRUM LIP BALM Raining Rose, Inc a75d0651-6001-29ce-e053-2a95a90a967f 2023-10-23 Warnings Exact identifier application number: M020 Coconut Mineral SPF 15 Broad Spectrum Lip Balm COCONUT MINERAL SPF 15 BROAD SPECTRUM LIP BALM Raining Rose, Inc b7b542fa-b0d2-7b33-e053-2995a90a7119 2023-10-23 Warnings Exact identifier application number: M020 Vanilla SPF 30 Broad Spectrum Lip Balm VANILLA SPF 30 BROAD SPECTRUM LIP BALM Raining Rose, Inc b7b542fa-b0c2-7b33-e053-2995a90a7119 2023-10-23 Warnings Exact identifier application number: M020 Pineapple Mineral SPF 15 Broad Spectrum Lip Balm PINEAPPLE MINERAL SPF 15 BROAD SPECTRUM LIP BALM Raining Rose, Inc b7c6684f-1122-20c1-e053-2995a90ae6cf 2023-10-23 Warnings Exact identifier application number: M020 Farmasi CC Cream LIGHT to MEDIUM 02 TITANIUM DIOXIDE TAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI 28b3fdff-1986-4048-9ed5-a3d784a4014e 2023-10-23 Warnings Exact identifier application number: M020 Farmasi CC Cream- MEDIUM 03 TITANIUM DIOXIDE TAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI 65de3c45-8ec2-4d73-8a29-6203d3b47bd7 2023-10-23 Warnings Exact identifier application number: M020 Farmasi BB Cream- MEDIUM 03 TITANIUM DIOXIDE TAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI 9102aa2f-0308-4985-b8a8-8e105047b61f 2023-10-23 Warnings Exact identifier application number: M020 Caribbean Breeze SPF 15 Broad Spectrum Lip Balm CARIBBEAN BREEZE SPF 15 BROAD SPECTRUM LIP BALM Raining Rose, Inc a75a42f6-27d1-e2cc-e053-2a95a90aa6da 2023-10-23 Warnings Exact identifier application number: M020 Iced Pear SPF 15 Broad Spectrum Lip Balm ICED PEAR SPF 15 BROAD SPECTRUM LIP BALM Raining Rose, Inc a8c4a0ec-e07e-1cda-e053-2a95a90a0f3f 2023-10-23 Warnings Exact identifier application number: M020 Lemonade SPF 15 Broad Spectrum Lip Balm LEMONADE SPF 15 BROAD SPECTRUM LIP BALM Raining Rose, Inc a8ffc32b-b758-0f8f-e053-2995a90adb62 2023-10-23 Warnings Exact identifier application number: M020 Strawberry SPF 15 Broad Spectrum Lip Balm STRAWBERRY SPF 15 BROAD SPECTRUM LIP BALM Raining Rose, Inc a902d590-0726-ad6f-e053-2995a90a1130 2023-10-23 Warnings Exact identifier application number: M020 Orange Creamsicle SPF 15 Broad Spectrum Lip Balm ORANGE CREAMSICLE SPF 15 BROAD SPECTRUM LIP BALM Raining Rose, Inc a9005cb1-ae1a-7736-e053-2995a90a28ea 2023-10-23 Warnings Exact identifier application number: M020 Neora Age IQ Invisi-Bloc Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Neora, LLC f2f3601f-081a-4bae-e053-2a95a90a4fac 2023-10-23 Warnings Exact identifier application number: M020 Neora Age IQ Invisi-Bloc Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Neora, LLC 82f48635-1dc4-8c0d-e053-2991aa0a60cc 2023-10-23 Warnings Exact identifier application number: M020 Artistry Exact Fit Longwearing Foundation Shade Golden L4N1 TITANIUM DIOXIDE Amway Corp 7494fe09-40e0-4152-9974-a6e8a4d7f421 2023-10-22 Warnings Exact identifier application number: M020 Artistry Exact Fit Longwearing Foundation Shade Soleil L3W1 TITANIUM DIOXIDE Amway Corp cec51b88-a6b8-4b64-b3aa-830e712a3c8a 2023-10-22 Warnings Exact identifier application number: M020 Artistry Exact Fit Longwearing Foundation Shade Tawny L3N1 TITANIUM DIOXIDE Amway Corp 706e1504-fad7-44fa-9030-f5b948e3e79b 2023-10-22 Warnings Exact identifier application number: M020 Artistry Exact Fit Longwearing Foundation Shade Cappuccino L5W1 TITANIUM DIOXIDE Amway Corp b785af89-1134-4fc6-8388-c47c52d153e0 2023-10-22 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