Home NDC 83294-101 SPF 30 Sunscreen
Product NDC 83294-101
11-digit product format 832940101
Labeler code 83294
Product ID 83294-101_471ab663-50b0-9e95-e063-6294a90a6115
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide, Titanium Dioxide
Dosage form LOTION
Route TOPICAL
Labeler CLEURE
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-08-22
Substance ZINC OXIDE; TITANIUM DIOXIDE
Active strength 9; 4.51 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 SPF 30 Sunscreen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 9 g/100mL TITANIUM DIOXIDE 4.51 g/100mL
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 15FIX9V2JP Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83294-101-18 SPF 30 Sunscreen 118 mL in 1 TUBE LOTION 118 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83294-101 SPF 30 SUNSCREEN (ZINC OXIDE, TITANIUM DIOXIDE) LOTION [CLEURE] 3 Current NDC, 1 package rows 20250101_f5512f34-08ee-b0f6-e053-2a95a90ab5bd.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 346 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Antioxidant Sunscreen SPF 40 OCTINOXATE AND ZINC OXIDE Topiderm, Inc. 2686378c-8827-47fb-b3ed-07438bd4e9e2 2019-11-13 Warnings Exact identifier application number: M020 No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Cool Vanilla OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE BCM Cosmetique SAS d701c221-9f68-47ff-b766-2f4f1998649f 2019-10-08 Warnings Exact identifier application number: M020 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 Sample Exclude flag Status 83294-101-18 83294010118 118 mL in 1 TUBE (83294-101-18) 118 ml 2022-08-22 No No Current