Algenist

Product NDC
53407-138
11-digit product format
534070138
Labeler code
53407
Product ID
53407-138_682009a5-901e-4b7a-b9e9-8f644a1fcf43
Type
HUMAN OTC DRUG
Nonproprietary name
Octinoxate, Titanium Dioxide, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Solazyme, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-08-01
Substance
OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE
Active strength
75; 20; 171 mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 26 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53407-138-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53407-138-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53407-138-30557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage53407-138-308af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage53407-138-30834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage53407-138-301332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage53407-138-30fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage53407-138-3086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage53407-138-30bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage53407-138-308dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage53407-138-30e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage53407-138-309bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage53407-138-30110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Algenist
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE75 mg/mL
TITANIUM DIOXIDE20 mg/mL
ZINC OXIDE171 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4Y5P7MUD51Internal UNII lookup
15FIX9V2JPInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4ece1847-1c94-4bf7-b936-109556a460a7Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53407-138-302025-01-09C16284748780-19855d018-d637-cd31-e053-dbdaa90ab51aDrug Facts
53407-138-302019-11-27C16284748780-19855d018-d637-cd31-e053-dbdaa90ab51aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53407-138-30Algenist1 in 1 BOXCREAM14
53407-138-30Algenist1 in 1 CARTONCREAM14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OctinoxateACTIVE INGREDIENT4Y5P7MUD51ALGENIST (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SOLAZYME, INC.]2
Titanium DioxideACTIVE INGREDIENT15FIX9V2JPALGENIST (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SOLAZYME, INC.]2
Zinc OxideACTIVE INGREDIENTSOI2LOH54ZALGENIST (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SOLAZYME, INC.]2
OctinoxateACTIVE MOIETY4Y5P7MUD51ALGENIST (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SOLAZYME, INC.]2
Titanium DioxideACTIVE MOIETY15FIX9V2JPALGENIST (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SOLAZYME, INC.]2
Zinc OxideACTIVE MOIETYSOI2LOH54ZALGENIST (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SOLAZYME, INC.]2
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0ALGENIST (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SOLAZYME, INC.]2
alcoholINACTIVE INGREDIENT3K9958V90MALGENIST (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SOLAZYME, INC.]2
aluminum hydroxideINACTIVE INGREDIENT5QB0T2IUN0ALGENIST (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SOLAZYME, INC.]2
ARCTOSTAPHYLOS UVA-URSI LEAFINACTIVE INGREDIENT3M5V3D1X36ALGENIST (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SOLAZYME, INC.]2
camellia oleifera seedINACTIVE INGREDIENT59ED29FM2JALGENIST (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SOLAZYME, INC.]2
caprylyl glycolINACTIVE INGREDIENT00YIU5438UALGENIST (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SOLAZYME, INC.]2
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0RALGENIST (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SOLAZYME, INC.]2
echinacea purpureaINACTIVE INGREDIENTQI7G114Y98ALGENIST (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SOLAZYME, INC.]2
ethylhexylglycerinINACTIVE INGREDIENT147D247K3PALGENIST (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SOLAZYME, INC.]2
glycerinINACTIVE INGREDIENTPDC6A3C0OXALGENIST (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SOLAZYME, INC.]2
GLYCYRRHIZA GLABRAINACTIVE INGREDIENT2788Z9758HALGENIST (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SOLAZYME, INC.]2
hexylene glycolINACTIVE INGREDIENTKEH0A3F75JALGENIST (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SOLAZYME, INC.]2
METHYL METHACRYLATEINACTIVE INGREDIENT196OC77688ALGENIST (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SOLAZYME, INC.]2
peg/ppg-18/18 dimethiconeINACTIVE INGREDIENT9H0AO7T794ALGENIST (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SOLAZYME, INC.]2
phenoxyethanolINACTIVE INGREDIENTHIE492ZZ3TALGENIST (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SOLAZYME, INC.]2
stearic acidINACTIVE INGREDIENT4ELV7Z65APALGENIST (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SOLAZYME, INC.]2
waterINACTIVE INGREDIENT059QF0KO0RALGENIST (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SOLAZYME, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53407-138ALGENIST (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SOLAZYME, INC.]4Current NDC, Legacy NDC, 2 package rows20250424_4ece1847-1c94-4bf7-b936-109556a460a7.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 89 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC228fab45-e0d2-f219-e063-6294a90a1ef62026-01-05WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC228055ec-ff59-4412-e063-6394a90abe142026-01-05WarningsExact identifier
application number: M020
SHISEIDO UV PROTECTIVE FOUNDATION FAIR IVORYOCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION236bdb53-d7a5-43a2-8a0c-bce4a5522e262026-01-05WarningsExact identifier
application number: M020
SHISEIDO BENEFIANCE WRINKLE SMOOTHING DAYAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONESHISEIDO AMERICAS CORPORATION4bd99626-690b-49e8-8c42-a2e2dbca09bf2026-01-05WarningsExact identifier
application number: M020
cle de peau BEAUTE LONG-LASTING HYDRATING VEILAVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATIONf04ece6c-66b6-48e9-8f6b-e898a538ba002026-01-05WarningsExact identifier
application number: M020
cle de peau BEAUTE RADIANT FOUNDATION N I10OCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION05ffb157-5e28-4e94-866d-9e3371480d842026-01-05WarningsExact identifier
application number: M020
cle de peau BEAUTE CONCEALER N 1TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONeedf8065-8897-4773-9cbb-bab57d2dd04f2026-01-05WarningsExact identifier
application number: M020
cle de peau BEAUTE BRIGHTENING ENHANCER VEILOCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONbb00d6d7-cc51-4fee-a0df-68bbd5bc50d62026-01-05WarningsExact identifier
application number: M020
cle de peau BEAUTE THE FOUNDATION N I10 VERY LIGHT IVORYOCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONbeefe840-6f32-483b-8a37-2696adb8eea12026-01-05WarningsExact identifier
application number: M020
cle de peau BEAUTE PROTECTIVE LIP TREATMENT SPF 25AVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATIONaddd9885-362c-4ce0-9a6e-759e71d8756c2026-01-05WarningsExact identifier
application number: M020
cle de peau BEAUTE PROTECTIVE FORTIFYING nAVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONESHISEIDO AMERICAS CORPORATION65ca1240-6ee8-40c0-b62f-3597e0872c6e2026-01-05WarningsExact identifier
application number: M020
cle de peau BEAUTE CORRECTING VEIL n MENSULIZOLE, OCTINOXATE, AND ZINC OXIDESHISEIDO AMERICAS CORPORATION15a258a0-61c3-4419-bcdb-a8197d5ae46f2026-01-05WarningsExact identifier
application number: M020
Dominas Dark Spot UV Defense Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG H&H Co.,Ltd.098c0a9b-2b96-6be3-e063-6294a90a959a2026-01-05WarningsExact identifier
application number: M020
Poolside Butter Screen SPF 30 Sunscreen ButterHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLCae838725-79ab-4c17-905b-d4138ad6af1f2026-01-05WarningsExact identifier
application number: M020
Poolside Bronze Service Instant Bronzing Sunscreen SPF 30HOMOSALATE, OCTOCRYLENE, OCTISALATE, OCTINOXATE, AVOBENZONEI World LLCb98a9cec-3c48-4614-b091-4e59fa7d196e2026-01-05WarningsExact identifier
application number: M020
Poolside Orange Creme SPF 30 Sunscreen Oil MistHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLC5a9f8888-529d-40d7-9489-baa5ff657cb42026-01-05WarningsExact identifier
application number: M020
Yon-Ka 50 Mineral FluidZINC OXIDELaboratoire MULTALER Yon-Ka47a8c8b2-30ff-0d40-e063-6294a90ac4612026-01-05WarningsExact identifier
application number: M020
SHISEIDO FUTURE solution LX UNIVERSAL DEFENSE EOCTISALATE, OCTOCRYLENE, AND ZINC OXIDESHISEIDO AMERICAS CORPORATION6d2f82d5-b3af-44af-b6b0-de96a4cd95fc2026-01-05WarningsExact identifier
application number: M020
SHISEIDO SPORTS BB LIGHTOCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION260a3eab-8fe6-4259-8dcc-3706ca1f68812026-01-05WarningsExact identifier
application number: M020
SHISEIDO VITAL PERFECTION UPLIFTING AND FIRMING DAYAVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND HOMOSALATESHISEIDO AMERICAS CORPORATION4a16dbb7-e860-4aae-8e8b-67abbe8295bd2026-01-05WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53407-138-30534070138301 CARTON in 1 BOX (53407-138-30) / 1 JAR in 1 CARTON / 30 mL in 1 JAR1 carton2012-08-01NoNoCurrent