Lip Protector Sunscreen SPF15

Product NDC
51531-9480
11-digit product format
515319480
Labeler code
51531
Product ID
51531-9480_49358ccd-fda4-403e-8ce9-009257ad6ba9
Type
HUMAN OTC DRUG
Nonproprietary name
Octinoxate,Zinc Oxide,Oxybenzone
Dosage form
LIPSTICK
Route
TOPICAL
Labeler
Mary Kay INC.
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2007-03-01
Marketing end
0000-00-00
Substance
OCTINOXATE; OXYBENZONE; ZINC OXIDE
Active strength
0 g/4.5g; g/4.5g; g/4.5g
NDC exclude flag
E
Listing certified through
2018-12-31
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 productproduct51531-9480IInactivated by FDA2026-10-05
excluded packagepackage51531-948051531-9480-0IInactivated by FDA2026-10-05

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 NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51531-9480-0IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51531-9480-0IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51531-9480-0IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51531-9480-0IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51531-9480-0IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51531-9480-0IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51531-9480-0IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51531-9480-0IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51531-9480-0IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51531-9480-0IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage51531-9480-0IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage51531-9480-0IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage51531-9480-0IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage51531-9480-0IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage51531-9480-0IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage51531-9480-0IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage51531-9480-0IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage51531-9480-0IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage51531-9480-0IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage51531-9480-0IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage51531-9480-0IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage51531-9480-0EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51531-9480-02020-01-31C16284748780-19d75b9cf-d523-f424-e053-dadaa90a57ce376f984e-0ecb-489b-9b76-c77b4416f04a

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51531-9480-0Lip Protector Sunscreen SPF154.5 g in 1 CONTAINERLIPSTICK4.52

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OctinoxateACTIVE INGREDIENT4Y5P7MUD51LIP PROTECTOR SUNSCREEN SPF15 (OCTINOXATE,ZINC OXIDE,OXYBENZONE) LIPSTICK [MARY KAY INC.]2
OxybenzoneACTIVE INGREDIENT95OOS7VE0YLIP PROTECTOR SUNSCREEN SPF15 (OCTINOXATE,ZINC OXIDE,OXYBENZONE) LIPSTICK [MARY KAY INC.]2
Zinc OxideACTIVE INGREDIENTSOI2LOH54ZLIP PROTECTOR SUNSCREEN SPF15 (OCTINOXATE,ZINC OXIDE,OXYBENZONE) LIPSTICK [MARY KAY INC.]2
OctinoxateACTIVE MOIETY4Y5P7MUD51LIP PROTECTOR SUNSCREEN SPF15 (OCTINOXATE,ZINC OXIDE,OXYBENZONE) LIPSTICK [MARY KAY INC.]2
OxybenzoneACTIVE MOIETY95OOS7VE0YLIP PROTECTOR SUNSCREEN SPF15 (OCTINOXATE,ZINC OXIDE,OXYBENZONE) LIPSTICK [MARY KAY INC.]2
Zinc OxideACTIVE MOIETYSOI2LOH54ZLIP PROTECTOR SUNSCREEN SPF15 (OCTINOXATE,ZINC OXIDE,OXYBENZONE) LIPSTICK [MARY KAY INC.]2
ACETATE IONINACTIVE INGREDIENT569DQM74SCLIP PROTECTOR SUNSCREEN SPF15 (OCTINOXATE,ZINC OXIDE,OXYBENZONE) LIPSTICK [MARY KAY INC.]2
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQLIP PROTECTOR SUNSCREEN SPF15 (OCTINOXATE,ZINC OXIDE,OXYBENZONE) LIPSTICK [MARY KAY INC.]2
ALPHA-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1LIP PROTECTOR SUNSCREEN SPF15 (OCTINOXATE,ZINC OXIDE,OXYBENZONE) LIPSTICK [MARY KAY INC.]2
CERESININACTIVE INGREDIENTQ1LS2UJO3ALIP PROTECTOR SUNSCREEN SPF15 (OCTINOXATE,ZINC OXIDE,OXYBENZONE) LIPSTICK [MARY KAY INC.]2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNLIP PROTECTOR SUNSCREEN SPF15 (OCTINOXATE,ZINC OXIDE,OXYBENZONE) LIPSTICK [MARY KAY INC.]2
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MLIP PROTECTOR SUNSCREEN SPF15 (OCTINOXATE,ZINC OXIDE,OXYBENZONE) LIPSTICK [MARY KAY INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LIP PROTECTOR SUNSCREEN SPF15 (OCTINOXATE,ZINC OXIDE,OXYBENZONE) LIPSTICK [MARY KAY INC.]2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9ULIP PROTECTOR SUNSCREEN SPF15 (OCTINOXATE,ZINC OXIDE,OXYBENZONE) LIPSTICK [MARY KAY INC.]2
POLYHYDROXYSTEARIC ACID (2300 MW)INACTIVE INGREDIENTYXH47AOU0FLIP PROTECTOR SUNSCREEN SPF15 (OCTINOXATE,ZINC OXIDE,OXYBENZONE) LIPSTICK [MARY KAY INC.]2
SOYBEAN OILINACTIVE INGREDIENT241ATL177ALIP PROTECTOR SUNSCREEN SPF15 (OCTINOXATE,ZINC OXIDE,OXYBENZONE) LIPSTICK [MARY KAY INC.]2
TRIETHOXYCAPRYLYLSILANEINACTIVE INGREDIENTLDC331P08ELIP PROTECTOR SUNSCREEN SPF15 (OCTINOXATE,ZINC OXIDE,OXYBENZONE) LIPSTICK [MARY KAY INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51531-9480LIP PROTECTOR SUNSCREEN SPF15 (OCTINOXATE,ZINC OXIDE,OXYBENZONE) LIPSTICK [MARY KAY INC.]2Legacy NDC, 1 package rows20120103_376f984e-0ecb-489b-9b76-c77b4416f04a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
51531-9480-0515319480004.5 g in 1 CONTAINER4.5 gHistorical