OP Protective Spray Gel 8

Product NDC
62802-038
11-digit product format
628020038
Labeler code
62802
Product ID
62802-038_2a9663ac-477e-4516-bda6-9016ced432ab
Type
HUMAN OTC DRUG
Nonproprietary name
octinoxate, octisalate
Dosage form
SPRAY
Route
TOPICAL
Labeler
Sun & Skin Care Research, Inc
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-01-01
Marketing end
0000-00-00
Substance
OCTINOXATE; OCTISALATE
Active strength
5 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 productproduct62802-038IInactivated by FDA2026-10-05
excluded packagepackage62802-03862802-038-85IInactivated 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 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 packagepackage62802-038-85d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage62802-038-85f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage62802-038-852ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage62802-038-85a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage62802-038-85cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage62802-038-85cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage62802-038-85302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage62802-038-85ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage62802-038-850efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage62802-038-85ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage62802-038-85367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage62802-038-85557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage62802-038-858af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage62802-038-85834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage62802-038-851332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage62802-038-85fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage62802-038-8586f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage62802-038-85bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage62802-038-858dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage62802-038-85e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage62802-038-859bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage62802-038-85110d247fa046…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
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62802-038-852019-11-13C16284748780-197449f38-b684-f6ea-e053-dbdaa90aa703DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62802-038-85OP Protective Spray Gel 8251 mL in 1 BOTTLESPRAY2511

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51OP PROTECTIVE SPRAY GEL 8 (OCTINOXATE, OCTISALATE) SPRAY [SUN & SKIN CARE RESEARCH, INC]1
OCTISALATEACTIVE INGREDIENT4X49Y0596WOP PROTECTIVE SPRAY GEL 8 (OCTINOXATE, OCTISALATE) SPRAY [SUN & SKIN CARE RESEARCH, INC]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51OP PROTECTIVE SPRAY GEL 8 (OCTINOXATE, OCTISALATE) SPRAY [SUN & SKIN CARE RESEARCH, INC]1
OCTISALATEACTIVE MOIETY4X49Y0596WOP PROTECTIVE SPRAY GEL 8 (OCTINOXATE, OCTISALATE) SPRAY [SUN & SKIN CARE RESEARCH, INC]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XOP PROTECTIVE SPRAY GEL 8 (OCTINOXATE, OCTISALATE) SPRAY [SUN & SKIN CARE RESEARCH, INC]1
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0OP PROTECTIVE SPRAY GEL 8 (OCTINOXATE, OCTISALATE) SPRAY [SUN & SKIN CARE RESEARCH, INC]1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8OP PROTECTIVE SPRAY GEL 8 (OCTINOXATE, OCTISALATE) SPRAY [SUN & SKIN CARE RESEARCH, INC]1
CARAMELINACTIVE INGREDIENTT9D99G2B1ROP PROTECTIVE SPRAY GEL 8 (OCTINOXATE, OCTISALATE) SPRAY [SUN & SKIN CARE RESEARCH, INC]1
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT1G56KV7BUJOP PROTECTIVE SPRAY GEL 8 (OCTINOXATE, OCTISALATE) SPRAY [SUN & SKIN CARE RESEARCH, INC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KOP PROTECTIVE SPRAY GEL 8 (OCTINOXATE, OCTISALATE) SPRAY [SUN & SKIN CARE RESEARCH, INC]1
ETHYLPARABENINACTIVE INGREDIENT14255EXE39OP PROTECTIVE SPRAY GEL 8 (OCTINOXATE, OCTISALATE) SPRAY [SUN & SKIN CARE RESEARCH, INC]1
ISOBUTYLPARABENINACTIVE INGREDIENT0QQJ25X58GOP PROTECTIVE SPRAY GEL 8 (OCTINOXATE, OCTISALATE) SPRAY [SUN & SKIN CARE RESEARCH, INC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TOP PROTECTIVE SPRAY GEL 8 (OCTINOXATE, OCTISALATE) SPRAY [SUN & SKIN CARE RESEARCH, INC]1
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1EOP PROTECTIVE SPRAY GEL 8 (OCTINOXATE, OCTISALATE) SPRAY [SUN & SKIN CARE RESEARCH, INC]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TOP PROTECTIVE SPRAY GEL 8 (OCTINOXATE, OCTISALATE) SPRAY [SUN & SKIN CARE RESEARCH, INC]1
POLYISOBUTYLENE (2300 MW)INACTIVE INGREDIENTDSQ2V1DD1KOP PROTECTIVE SPRAY GEL 8 (OCTINOXATE, OCTISALATE) SPRAY [SUN & SKIN CARE RESEARCH, INC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3OP PROTECTIVE SPRAY GEL 8 (OCTINOXATE, OCTISALATE) SPRAY [SUN & SKIN CARE RESEARCH, INC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHOP PROTECTIVE SPRAY GEL 8 (OCTINOXATE, OCTISALATE) SPRAY [SUN & SKIN CARE RESEARCH, INC]1
SORBITAN MONOOLEATEINACTIVE INGREDIENT06XEA2VD56OP PROTECTIVE SPRAY GEL 8 (OCTINOXATE, OCTISALATE) SPRAY [SUN & SKIN CARE RESEARCH, INC]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKOP PROTECTIVE SPRAY GEL 8 (OCTINOXATE, OCTISALATE) SPRAY [SUN & SKIN CARE RESEARCH, INC]1
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVCOP PROTECTIVE SPRAY GEL 8 (OCTINOXATE, OCTISALATE) SPRAY [SUN & SKIN CARE RESEARCH, INC]1
WATERINACTIVE INGREDIENT059QF0KO0ROP PROTECTIVE SPRAY GEL 8 (OCTINOXATE, OCTISALATE) SPRAY [SUN & SKIN CARE RESEARCH, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62802-038OP PROTECTIVE SPRAY GEL 8 (OCTINOXATE, OCTISALATE) SPRAY [SUN & SKIN CARE RESEARCH, INC]1Legacy NDC, 1 package rows20120327_354680b3-7357-4ff2-8386-697f809f5a36.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
62802-038-8562802003885251 mL in 1 BOTTLE251 mlHistorical