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 225 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sun Defense Minerals (Medium) ZINC OXIDE, TITANIUM DIOXIDE Eminence Organic Skin Care 2e2297d4-3649-a749-e063-6294a90ac284 2025-02-14 Warnings Exact identifier application number: M020 Sun Defense Minerals (Light) ZINC OXIDE, TITANIUM DIOXIDE Eminence Organic Skin Care 2e22cfde-10a1-3742-e063-6394a90ac097 2025-02-14 Warnings Exact identifier application number: M020 Cell Fusion C Derma UV Mineral Sunscreen Broad Spectrum SPF 50 HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE CMS LAB Inc. 2e5c2add-8ed0-a990-e063-6394a90a87ea 2025-02-14 Warnings Exact identifier application number: M020 Les Duets - Shield of Helios, sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 385f75a5-6a3b-a129-e063-6394a90a52a0 2025-02-14 Warnings Exact identifier application number: M020 Le Mieux Naked Glow Bronzer SPF 50 SUNSCREEN YB CHEMIA LLC 46465db7-c1f0-6980-e063-6294a90a3ed8 2025-02-14 Warnings Exact identifier application number: M020 Sheer Tint Mineral SPF Serum - Light Light ZINC OXIDE Mineral Fusion brands ac6fdc35-82f8-4805-875e-2aa91aedec6f 2025-02-14 Warnings Exact identifier application number: M020 Fre Protect Me Lightweight Daily Moisturizer SPF 50 ZINC OXIDE Peer Pharm Ltd. 3989eebc-7262-4cda-84a1-ca30b638b772 2025-02-13 Warnings Exact identifier application number: M020 Fre Protect Me Lightweight Daily Moisturizer SPF 30 ZINC OXIDE Peer Pharm Ltd. 8ee9f97b-9081-4e0c-aa7a-27a31cbee17a 2025-02-13 Warnings Exact identifier application number: M020 Fre Glow Me Lightweight Tinted Moisturizer Medium Deep ZINC OXIDE Peer Pharm Ltd. 45ed56e1-46cb-46de-b11a-e814a7446e57 2025-02-13 Warnings Exact identifier application number: M020 Fre Glow Me Lightweight Tinted Moisturizer Light Medium ZINC OXIDE Peer Pharm Ltd. 6815f8d6-0d78-4d4d-8d8c-6a1153a5f61a 2025-02-13 Warnings Exact identifier application number: M020 Neutrogena Mineral Ultra Sheer Dry Touch SPF 30 TITANIUM DIOXIDE, ZINC OXIDE Kenvue Brands LLC e99311c2-ed8b-6e60-e053-2a95a90a9bc2 2025-02-13 Warnings Exact identifier application number: M020 Neutrogena Sheer Zinc Mineral Sunscreen Broad Spectrum SPF 50 ZINC OXIDE Kenvue Brands LLC 525f7bae-44b8-44e4-93ea-32995eca2566 2025-02-13 Warnings Exact identifier application number: M020 DreamBeam Sunscreen Sunlit SUNSCREEN ZINC OXIDE Kosas Cosmetics, LLC 2e093b82-2a36-cc0f-e063-6394a90a4d6d 2025-02-13 Warnings Exact identifier application number: M020 DreamBeam Sunscreen SUNSCREEN ZINC OXIDE Kosas Cosmetics, LLC f93b0091-6a41-ae6e-e053-6394a90a86d7 2025-02-13 Warnings Exact identifier application number: M020 Revealer Skin-Improving Foundation SUNSCREEN ZINC OXIDE Kosas Cosmetics, LLC 2e0a0cd6-c302-2017-e063-6394a90a60b8 2025-02-13 Warnings Exact identifier application number: M020 Hi papa KIDS MINERAL FACE SUNSCREEN SUNSCREEN GUANG DONG 3 INS TECHNOLOGY Co., Ltd 2deea723-32a0-da33-e063-6294a90accdd 2025-02-12 Warnings Exact identifier application number: M020 Quick Screen Sunscreen SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE The Quick Flick PTY LTD 3788666e-7efa-43da-95f5-6218b7fcb6ea 2025-02-12 Warnings Exact identifier application number: M020 Dolce AND Gabbana Get Your Healthy Glowy Skin ZINC OXIDE Socoplan 91bf1cca-8d18-4c59-864d-4fd0619c6713 2025-02-12 Warnings Exact identifier application number: M020 Cell Fusion C Aquatica UV Defense Sunscreen Broad Spectrum SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE CMS LAB Inc. 2dfd1f99-5896-1e0f-e063-6394a90aa71d 2025-02-12 Warnings Exact identifier application number: M020 Biore Aqua Rich UV OCTOCRYLENE, OCTISALATE, AVOBENZENE, HOMOSALATE KAO USA f9024581-dbab-b7cb-e053-6294a90a8b9a 2025-02-12 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