Home NDC 36800-347 TOPCO TOPCARE EVERYDAY BABY PROTECTION SUN SPF 50
Product NDC 36800-347
11-digit product format 368000347
Labeler code 36800
Product ID 36800-347_24882f00-521b-2de9-e063-6394a90a1bf9
Type HUMAN OTC DRUG
Nonproprietary name OCTISALATE, ZINC OXIDE
Dosage form LOTION
Route TOPICAL
Labeler TOPCO ASSOCIATES LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-11-02
Substance ZINC OXIDE; OCTISALATE
Active strength 145; 50 mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2027-12-31
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 TOPCO TOPCARE EVERYDAY BABY PROTECTION SUN SPF 50
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 145 mg/mL OCTISALATE 50 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup 4X49Y0596W Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 36800-347-11 TOPCO TOPCARE EVERYDAY BABY PROTECTION SUN SPF 50 237 mL in 1 BOTTLE LOTION 237 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-347 TOPCO TOPCARE EVERYDAY BABY PROTECTION SUN SPF 50 (OCTISALATE, ZINC OXIDE) LOTION [TOPCO ASSOCIATES LLC] 2 Current NDC, 1 package rows 20241017_f71c9060-3daf-e1be-e053-6294a90a4f91.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 203 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join GHOSTED ZINC OXIDE Spooge a5b611c3-d4d3-461e-84d8-d04a29c74902 2025-06-26 Warnings Exact identifier application number: M020 Dew Me ZINC OXIDE Spooge 0c4b429b-7dd5-4929-95af-d02b6770f121 2025-06-26 Warnings Exact identifier application number: M020 Zinc FIVE-0 baby and kids mineral sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 38744f77-4845-eac4-e063-6294a90af648 2025-06-26 Warnings Exact identifier application number: M020 NYU Langone Health Lip Balm ZINC OXIDE Guangdong Aimu Biological Technology Co., Ltd 38745b55-8da5-4627-e063-6394a90a24ca 2025-06-26 Warnings Exact identifier application number: M020 Active Skin Repair hydrating daily sunscreen ZINC OXIDE Innovacyn, Inc. 1eacdde1-f990-4962-92f1-3f41a8a3b193 2025-06-26 Warnings Exact identifier application number: M020 Cheeky ZINC OXIDE Spooge d377379a-a1be-4acf-9df5-2ff73fb5c83d 2025-06-26 Warnings Exact identifier application number: M020 TheOG ZINC OXIDE Spooge a2f781a8-eba8-48f5-8680-9235aae8a4ff 2025-06-26 Warnings Exact identifier application number: M020 Reef safe - Vitamin C sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 385f0763-74e9-3a71-e063-6394a90a46fb 2025-06-25 Warnings Exact identifier application number: M020 Reef safe - acne-prone sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 385f079c-5730-5111-e063-6394a90af2d8 2025-06-25 Warnings Exact identifier application number: M020 Reef safe - Zinc Face sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 385f0f79-016f-71a7-e063-6394a90a9286 2025-06-25 Warnings Exact identifier application number: M020 Reef safe - Baby zinc sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 385f320c-9144-78b8-e063-6394a90a2e9d 2025-06-25 Warnings Exact identifier application number: M020 Reef safe - Zinc Sport sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 385ff227-1656-960a-e063-6294a90a913c 2025-06-25 Warnings Exact identifier application number: M020 Thermasun SPF50 Mineral Zinc facial sunscreen ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 386ecba0-2f7f-9178-e063-6394a90a44c4 2025-06-25 Warnings Exact identifier application number: M020 Reefsun sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 386ec055-4ae7-9d2d-e063-6394a90a83c0 2025-06-25 Warnings Exact identifier application number: M020 SR Active Sheer Zinc Face Stick SPF 50 20.6% ZINC OXIDE Skinresource.md, L.L.C. 29928ab0-4467-57cb-e063-6394a90ac4d3 2025-06-25 Warnings Exact identifier application number: M020 Sun Protection SPF 50 AVOBENZONE 2.9%, HOMOSALATE 4.0%, OCTISALATE 4.9%, OCTOCRYLENE 9.5% Skinresource.md, L.L.C. 2a0c3dd1-4bc0-6664-e063-6294a90af4b3 2025-06-25 Warnings Exact identifier application number: M020 MELAO WHITENING SUNSCREEN TITANIUM DIOXIDE Guangdong Aimu Biological Technology Co., Ltd 1aaf5942-ff13-ee07-e063-6394a90acd28 2025-06-25 Warnings Exact identifier application number: M020 Blooskim BEEF TALLOW SUNSCREEN NON-NANO ZINC OXIDE Guangzhou Haishi Biological Technology Co., Ltd. 384903fa-e739-08b8-e063-6394a90a7653 2025-06-24 Warnings Exact identifier application number: M020 Walgreens SPF 55 Sheer Face Mist Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE WALGREEN COMPANY f05b45e2-2fcd-631e-e053-2995a90ad334 2025-06-24 Warnings Exact identifier application number: M020 Walgreens SPF 50 Premium Moisturizing Continuous Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE WALGREEN COMPANY 0b2b1ed5-8e53-00f3-e063-6394a90a14f8 2025-06-24 Warnings Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 36800-347-11 36800034711 237 mL in 1 BOTTLE (36800-347-11) 237 ml 2018-11-02 No No Current