Native Tan SPF 50

Product NDC
52854-250
Requested package NDC
52854-250-01
11-digit product format
528540250
Labeler code
52854
Product ID
52854-250_a02052cf-9970-2c17-e053-2995a90a2a8f
Type
HUMAN OTC DRUG
Nonproprietary name
octocrylene, octisalate, oxybenzone, and avobenzone
Dosage form
LOTION
Route
TOPICAL
Labeler
Tropical Seas, Inc.
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-07-01
Marketing end
0000-00-00
Substance
OCTOCRYLENE; OCTISALATE; OXYBENZONE; AVOBENZONE
Active strength
5 g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage52854-25052854-250-01DDiscontinued by firm2026-09-14

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 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2022-08-30 03:57 UTC · source 2022-08-29IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01IInactivated by FDAbd6a592717d7…303034d00443…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52854-250-012022-11-29C16284748780-1d6a99b39-d502-a426-e053-dadaa90af4c2d487b686-b286-47f5-8827-6b3456987751
52854-250-012022-01-28C16284748780-1d6a99b39-d502-a426-e053-dadaa90af4c2d487b686-b286-47f5-8827-6b3456987751

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
avobenzoneACTIVE INGREDIENTG63QQF2NOXNATIVE TAN SPF 50 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.]1
octisalateACTIVE INGREDIENT4X49Y0596WNATIVE TAN SPF 50 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.]1
octocryleneACTIVE INGREDIENT5A68WGF6WMNATIVE TAN SPF 50 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.]1
oxybenzoneACTIVE INGREDIENT95OOS7VE0YNATIVE TAN SPF 50 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.]1
avobenzoneACTIVE MOIETYG63QQF2NOXNATIVE TAN SPF 50 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.]1
octisalateACTIVE MOIETY4X49Y0596WNATIVE TAN SPF 50 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.]1
octocryleneACTIVE MOIETY5A68WGF6WMNATIVE TAN SPF 50 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.]1
oxybenzoneACTIVE MOIETY95OOS7VE0YNATIVE TAN SPF 50 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.]1
aloe vera leafINACTIVE INGREDIENTZY81Z83H0XNATIVE TAN SPF 50 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.]1
carbomer copolymer type b (allyl pentaerythritol crosslinked)INACTIVE INGREDIENT809Y72KV36NATIVE TAN SPF 50 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.]1
cetostearyl alcoholINACTIVE INGREDIENT2DMT128M1SNATIVE TAN SPF 50 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.]1
cetyl alcoholINACTIVE INGREDIENT936JST6JCNNATIVE TAN SPF 50 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.]1
cetyl dimethicone 150INACTIVE INGREDIENT5L694Y0T22NATIVE TAN SPF 50 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.]1
diazolidinyl ureaINACTIVE INGREDIENTH5RIZ3MPW4NATIVE TAN SPF 50 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXNATIVE TAN SPF 50 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.]1
glyceryl stearate seINACTIVE INGREDIENTFCZ5MH785INATIVE TAN SPF 50 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.]1
high density polyethyleneINACTIVE INGREDIENTUG00KM4WR7NATIVE TAN SPF 50 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TNATIVE TAN SPF 50 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.]1
phenethyl benzoateINACTIVE INGREDIENT0C143929GKNATIVE TAN SPF 50 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.]1
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MNATIVE TAN SPF 50 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHNATIVE TAN SPF 50 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.]1
sodium hydroxideINACTIVE INGREDIENT55X04QC32INATIVE TAN SPF 50 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.]1
stearic acidINACTIVE INGREDIENT4ELV7Z65APNATIVE TAN SPF 50 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.]1
tricontanyl povidone (4 tricontanyl branches/repeat)INACTIVE INGREDIENTN0SS3Q238DNATIVE TAN SPF 50 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.]1
waterINACTIVE INGREDIENT059QF0KO0RNATIVE TAN SPF 50 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52854-250-0152854025001120 mL in 1 BOTTLE, PLASTIC (52854-250-01) 120 ml2012-07-010000-00-00NoNoCurrent