Safe Sea SPF 40

Product NDC
66134-040
11-digit product format
661340040
Labeler code
66134
Product ID
66134-040_8ff104fb-0095-dbc7-e053-2a95a90a3b35
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE, OCTISALATE, OCTOCRYLENE. AVOBENZONE, TITANIUM DIOXIDE
Dosage form
LOTION
Route
TOPICAL
Labeler
SASA Cosmetics
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2015-01-07
Marketing end
2022-04-30
Substance
OCTINOXATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE; TITANIUM DIOXIDE
Active strength
75 mg/g; mg/g; mg/g; mg/g; mg/g
NDC exclude flag
No
Listing certified through
0000-00-00
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 productproduct66134-040DDiscontinued by firm2026-10-12
excluded packagepackage66134-04066134-040-40DDiscontinued by firm2026-10-12

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 · 24 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 packagepackage66134-040-40d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66134-040-40f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66134-040-402ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66134-040-40a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66134-040-40cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66134-040-40cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage66134-040-40302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage66134-040-40ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage66134-040-400efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage66134-040-40ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage66134-040-40367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage66134-040-40557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXSAFE SEA SPF 40 (OCTINOXATE, OCTISALATE, OCTOCRYLENE. AVOBENZONE, TITANIUM DIOXIDE) LOTION [SASA COSMETICS]1
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51SAFE SEA SPF 40 (OCTINOXATE, OCTISALATE, OCTOCRYLENE. AVOBENZONE, TITANIUM DIOXIDE) LOTION [SASA COSMETICS]1
OCTISALATEACTIVE INGREDIENT4X49Y0596WSAFE SEA SPF 40 (OCTINOXATE, OCTISALATE, OCTOCRYLENE. AVOBENZONE, TITANIUM DIOXIDE) LOTION [SASA COSMETICS]1
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WMSAFE SEA SPF 40 (OCTINOXATE, OCTISALATE, OCTOCRYLENE. AVOBENZONE, TITANIUM DIOXIDE) LOTION [SASA COSMETICS]1
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPSAFE SEA SPF 40 (OCTINOXATE, OCTISALATE, OCTOCRYLENE. AVOBENZONE, TITANIUM DIOXIDE) LOTION [SASA COSMETICS]1
AVOBENZONEACTIVE MOIETYG63QQF2NOXSAFE SEA SPF 40 (OCTINOXATE, OCTISALATE, OCTOCRYLENE. AVOBENZONE, TITANIUM DIOXIDE) LOTION [SASA COSMETICS]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51SAFE SEA SPF 40 (OCTINOXATE, OCTISALATE, OCTOCRYLENE. AVOBENZONE, TITANIUM DIOXIDE) LOTION [SASA COSMETICS]1
OCTISALATEACTIVE MOIETY4X49Y0596WSAFE SEA SPF 40 (OCTINOXATE, OCTISALATE, OCTOCRYLENE. AVOBENZONE, TITANIUM DIOXIDE) LOTION [SASA COSMETICS]1
OCTOCRYLENEACTIVE MOIETY5A68WGF6WMSAFE SEA SPF 40 (OCTINOXATE, OCTISALATE, OCTOCRYLENE. AVOBENZONE, TITANIUM DIOXIDE) LOTION [SASA COSMETICS]1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPSAFE SEA SPF 40 (OCTINOXATE, OCTISALATE, OCTOCRYLENE. AVOBENZONE, TITANIUM DIOXIDE) LOTION [SASA COSMETICS]1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMSAFE SEA SPF 40 (OCTINOXATE, OCTISALATE, OCTOCRYLENE. AVOBENZONE, TITANIUM DIOXIDE) LOTION [SASA COSMETICS]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHSAFE SEA SPF 40 (OCTINOXATE, OCTISALATE, OCTOCRYLENE. AVOBENZONE, TITANIUM DIOXIDE) LOTION [SASA COSMETICS]1
CALCIUM CHLORIDEINACTIVE INGREDIENTM4I0D6VV5MSAFE SEA SPF 40 (OCTINOXATE, OCTISALATE, OCTOCRYLENE. AVOBENZONE, TITANIUM DIOXIDE) LOTION [SASA COSMETICS]1
CETYL DIMETHICONE 25INACTIVE INGREDIENTU4AS1BW4ZBSAFE SEA SPF 40 (OCTINOXATE, OCTISALATE, OCTOCRYLENE. AVOBENZONE, TITANIUM DIOXIDE) LOTION [SASA COSMETICS]1
CHLORPHENESININACTIVE INGREDIENTI670DAL4SZSAFE SEA SPF 40 (OCTINOXATE, OCTISALATE, OCTOCRYLENE. AVOBENZONE, TITANIUM DIOXIDE) LOTION [SASA COSMETICS]1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0RSAFE SEA SPF 40 (OCTINOXATE, OCTISALATE, OCTOCRYLENE. AVOBENZONE, TITANIUM DIOXIDE) LOTION [SASA COSMETICS]1
DEHYDROACETIC ACIDINACTIVE INGREDIENT2KAG279R6RSAFE SEA SPF 40 (OCTINOXATE, OCTISALATE, OCTOCRYLENE. AVOBENZONE, TITANIUM DIOXIDE) LOTION [SASA COSMETICS]1
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUSAFE SEA SPF 40 (OCTINOXATE, OCTISALATE, OCTOCRYLENE. AVOBENZONE, TITANIUM DIOXIDE) LOTION [SASA COSMETICS]1
LANTHANUM CHLORIDEINACTIVE INGREDIENT04M8624OXVSAFE SEA SPF 40 (OCTINOXATE, OCTISALATE, OCTOCRYLENE. AVOBENZONE, TITANIUM DIOXIDE) LOTION [SASA COSMETICS]1
MAGNESIUM CHLORIDEINACTIVE INGREDIENT02F3473H9OSAFE SEA SPF 40 (OCTINOXATE, OCTISALATE, OCTOCRYLENE. AVOBENZONE, TITANIUM DIOXIDE) LOTION [SASA COSMETICS]1
PHAEODACTYLUM TRICORNUTUMINACTIVE INGREDIENTY5W63E7HLVSAFE SEA SPF 40 (OCTINOXATE, OCTISALATE, OCTOCRYLENE. AVOBENZONE, TITANIUM DIOXIDE) LOTION [SASA COSMETICS]1
POLYGLYCERYL-4 ISOSTEARATEINACTIVE INGREDIENT820DPX33S7SAFE SEA SPF 40 (OCTINOXATE, OCTISALATE, OCTOCRYLENE. AVOBENZONE, TITANIUM DIOXIDE) LOTION [SASA COSMETICS]1
POLYSULFATED GLYCOSAMINOGLYCANINACTIVE INGREDIENT268AW7000TSAFE SEA SPF 40 (OCTINOXATE, OCTISALATE, OCTOCRYLENE. AVOBENZONE, TITANIUM DIOXIDE) LOTION [SASA COSMETICS]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SAFE SEA SPF 40 (OCTINOXATE, OCTISALATE, OCTOCRYLENE. AVOBENZONE, TITANIUM DIOXIDE) LOTION [SASA COSMETICS]1
SACCHAROMYCES CEREVISIAEINACTIVE INGREDIENT978D8U419HSAFE SEA SPF 40 (OCTINOXATE, OCTISALATE, OCTOCRYLENE. AVOBENZONE, TITANIUM DIOXIDE) LOTION [SASA COSMETICS]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRSAFE SEA SPF 40 (OCTINOXATE, OCTISALATE, OCTOCRYLENE. AVOBENZONE, TITANIUM DIOXIDE) LOTION [SASA COSMETICS]1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BSAFE SEA SPF 40 (OCTINOXATE, OCTISALATE, OCTOCRYLENE. AVOBENZONE, TITANIUM DIOXIDE) LOTION [SASA COSMETICS]1
STEARYL DIMETHICONE (400 MPA.S AT 50C)INACTIVE INGREDIENTR327X197HYSAFE SEA SPF 40 (OCTINOXATE, OCTISALATE, OCTOCRYLENE. AVOBENZONE, TITANIUM DIOXIDE) LOTION [SASA COSMETICS]1
TRIMETHOXYCAPRYLYLSILANEINACTIVE INGREDIENTFZ07E4LW2MSAFE SEA SPF 40 (OCTINOXATE, OCTISALATE, OCTOCRYLENE. AVOBENZONE, TITANIUM DIOXIDE) LOTION [SASA COSMETICS]1
WATERINACTIVE INGREDIENT059QF0KO0RSAFE SEA SPF 40 (OCTINOXATE, OCTISALATE, OCTOCRYLENE. AVOBENZONE, TITANIUM DIOXIDE) LOTION [SASA COSMETICS]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66134-040-4066134004040118 g in 1 TUBE (66134-040-40) 118 g2015-01-072022-04-30NoNoCurrent