SPF 15

Product NDC
76224-101
11-digit product format
762240101
Labeler code
76224
Product ID
76224-101_08b50aa0-79e9-4d93-a3bc-bf61410f21d4
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE,OXYBENZONE
Dosage form
LOTION
Route
TOPICAL
Labeler
Whish Body Holdings Inc
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2011-05-25
Marketing end
0000-00-00
Substance
OCTINOXATE; OXYBENZONE
Active strength
8 mL/100mL; mL/100mL
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct76224-101IInactivated by FDA2026-10-15
excluded packagepackage76224-10176224-101-02IInactivated by FDA2026-10-15

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage76224-101-02d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage76224-101-02f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage76224-101-022ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage76224-101-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage76224-101-02cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage76224-101-02cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage76224-101-02302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage76224-101-02ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage76224-101-020efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage76224-101-02ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage76224-101-02367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage76224-101-02557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage76224-101-028af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage76224-101-02834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage76224-101-021332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage76224-101-02fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage76224-101-0286f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage76224-101-02bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage76224-101-028dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage76224-101-02e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage76224-101-029bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage76224-101-02110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76224-101-022019-10-29C16284748780-1960f7f55-d5e6-8e05-e053-dbdaa90a074acoconut milk SPF 15 Self Tanner

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76224-101-01SPF 15Self Tanner150 mL in 1 BOTTLELOTION1502
76224-101-02SPF 15Self Tanner1 in 1 BOXLOTION12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51SPF 15 SELF TANNER (OCTINOXATE,OXYBENZONE) LOTION [WHISH BODY HOLDINGS INC]2
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YSPF 15 SELF TANNER (OCTINOXATE,OXYBENZONE) LOTION [WHISH BODY HOLDINGS INC]2
OCTINOXATEACTIVE MOIETY4Y5P7MUD51SPF 15 SELF TANNER (OCTINOXATE,OXYBENZONE) LOTION [WHISH BODY HOLDINGS INC]2
OXYBENZONEACTIVE MOIETY95OOS7VE0YSPF 15 SELF TANNER (OCTINOXATE,OXYBENZONE) LOTION [WHISH BODY HOLDINGS INC]2
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQSPF 15 SELF TANNER (OCTINOXATE,OXYBENZONE) LOTION [WHISH BODY HOLDINGS INC]2
ALLANTOININACTIVE INGREDIENT344S277G0ZSPF 15 SELF TANNER (OCTINOXATE,OXYBENZONE) LOTION [WHISH BODY HOLDINGS INC]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XSPF 15 SELF TANNER (OCTINOXATE,OXYBENZONE) LOTION [WHISH BODY HOLDINGS INC]2
ARABICA COFFEE BEANINACTIVE INGREDIENT3SW678MX72SPF 15 SELF TANNER (OCTINOXATE,OXYBENZONE) LOTION [WHISH BODY HOLDINGS INC]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHSPF 15 SELF TANNER (OCTINOXATE,OXYBENZONE) LOTION [WHISH BODY HOLDINGS INC]2
CITRALINACTIVE INGREDIENTT7EU0O9VPPSPF 15 SELF TANNER (OCTINOXATE,OXYBENZONE) LOTION [WHISH BODY HOLDINGS INC]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSPF 15 SELF TANNER (OCTINOXATE,OXYBENZONE) LOTION [WHISH BODY HOLDINGS INC]2
COCONUT OILINACTIVE INGREDIENTQ9L0O73W7LSPF 15 SELF TANNER (OCTINOXATE,OXYBENZONE) LOTION [WHISH BODY HOLDINGS INC]2
DIHYDROXYACETONEINACTIVE INGREDIENTO10DDW6JOOSPF 15 SELF TANNER (OCTINOXATE,OXYBENZONE) LOTION [WHISH BODY HOLDINGS INC]2
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PSPF 15 SELF TANNER (OCTINOXATE,OXYBENZONE) LOTION [WHISH BODY HOLDINGS INC]2
GERANIOLINACTIVE INGREDIENTL837108USYSPF 15 SELF TANNER (OCTINOXATE,OXYBENZONE) LOTION [WHISH BODY HOLDINGS INC]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSPF 15 SELF TANNER (OCTINOXATE,OXYBENZONE) LOTION [WHISH BODY HOLDINGS INC]2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4SPF 15 SELF TANNER (OCTINOXATE,OXYBENZONE) LOTION [WHISH BODY HOLDINGS INC]2
LIMONENE, (+)-INACTIVE INGREDIENTGFD7C86Q1WSPF 15 SELF TANNER (OCTINOXATE,OXYBENZONE) LOTION [WHISH BODY HOLDINGS INC]2
LINALOOL, (+)-INACTIVE INGREDIENTF4VNO44C09SPF 15 SELF TANNER (OCTINOXATE,OXYBENZONE) LOTION [WHISH BODY HOLDINGS INC]2
LYCIUM BARBARUM FRUITINACTIVE INGREDIENT930626MWDLSPF 15 SELF TANNER (OCTINOXATE,OXYBENZONE) LOTION [WHISH BODY HOLDINGS INC]2
MANGIFERA INDICA SEED BUTTERINACTIVE INGREDIENT4OXD9M35X2SPF 15 SELF TANNER (OCTINOXATE,OXYBENZONE) LOTION [WHISH BODY HOLDINGS INC]2
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7USPF 15 SELF TANNER (OCTINOXATE,OXYBENZONE) LOTION [WHISH BODY HOLDINGS INC]2
PANTHENOLINACTIVE INGREDIENTWV9CM0O67ZSPF 15 SELF TANNER (OCTINOXATE,OXYBENZONE) LOTION [WHISH BODY HOLDINGS INC]2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TSPF 15 SELF TANNER (OCTINOXATE,OXYBENZONE) LOTION [WHISH BODY HOLDINGS INC]2
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MSPF 15 SELF TANNER (OCTINOXATE,OXYBENZONE) LOTION [WHISH BODY HOLDINGS INC]2
POMEGRANATEINACTIVE INGREDIENT56687D1Z4DSPF 15 SELF TANNER (OCTINOXATE,OXYBENZONE) LOTION [WHISH BODY HOLDINGS INC]2
ROSEMARYINACTIVE INGREDIENTIJ67X351P9SPF 15 SELF TANNER (OCTINOXATE,OXYBENZONE) LOTION [WHISH BODY HOLDINGS INC]2
SHEA BUTTERINACTIVE INGREDIENTK49155WL9YSPF 15 SELF TANNER (OCTINOXATE,OXYBENZONE) LOTION [WHISH BODY HOLDINGS INC]2
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVCSPF 15 SELF TANNER (OCTINOXATE,OXYBENZONE) LOTION [WHISH BODY HOLDINGS INC]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEESPF 15 SELF TANNER (OCTINOXATE,OXYBENZONE) LOTION [WHISH BODY HOLDINGS INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76224-101SPF 15 SELF TANNER (OCTINOXATE,OXYBENZONE) LOTION [WHISH BODY HOLDINGS INC]2Legacy NDC, 2 package rows20110602_b598d34a-3b86-4b58-9b19-025fcf3a82dd.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
76224-101-0176224010101150 mL in 1 BOTTLE150 mlHistorical
76224-101-02762240101021 in 1 BOXHistorical