Home NDC 52854-908 Land Shark SPF 8
Product NDC 52854-908
11-digit product format 528540908
Labeler code 52854
Product ID 52854-908_42c9df65-9604-6288-e063-6394a90a8a30
Type HUMAN OTC DRUG
Nonproprietary name octinoxate and oxybenzone
Dosage form LOTION
Route TOPICAL
Labeler Tropical Seas, Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-07-22
Substance OCTINOXATE; OXYBENZONE
Active strength 4.5; 1.5 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 Land Shark SPF 8
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTINOXATE 4.5 g/100mL OXYBENZONE 1.5 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4Y5P7MUD51 Internal UNII lookup 95OOS7VE0Y 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 52854-908-01 Land Shark SPF 8 192 mL in 1 BOTTLE, PLASTIC LOTION 192 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52854-908 LAND SHARK SPF 8 (OCTINOXATE AND OXYBENZONE) LOTION [TROPICAL SEAS, INC.] 5 Current NDC, Legacy NDC, 1 package rows 20241103_b5e68448-4131-1c6c-e053-2a95a90a014a.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 Marketing end Sample Exclude flag Status 52854-908-01 52854090801 192 mL in 1 BOTTLE, PLASTIC (52854-908-01) 192 ml 2020-07-22 0000-00-00 No No Current