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 111 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Covergirl Clean Fresh Blurring Skintint SPF 30 Mineral Sunscreen Liquid Foundation- All shadesZINC OXIDENoxell3fa58ac5-f45c-369a-e063-6294a90a46e42025-12-17WarningsExact identifier
application number: M020
Ray Defense Broad Spectrum SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEBioelements807db1ff-a64a-44e4-a786-f88cd45184332025-12-17WarningsExact identifier
application number: M020
SPF 50 Face Sunscreen BioelementsAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEBioelements, Inc981c7b3c-d7d6-483d-bf32-10d526be5b3f2025-12-17WarningsExact identifier
application number: M020
Glow Oil SPF 50 Beach FlowerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLC2a46d7d2-293f-5024-e063-6294a90a31aa2025-12-17WarningsExact identifier
application number: M020
Coppertone Tanning Sunscreen SPF 15AVOBENZONE 2%, HOMOSALATE 5%, OCTISALATE 4.5%, OCTOCRYLENE 3%Beiersdorf Inc0f114022-daaa-1834-e063-6394a90afd1d2025-12-17WarningsExact identifier
application number: M020
Coppertone Tanning Sunscreen SPF 8AVOBENZONE 2%, HOMOSALATE 5%, OCTISALATE 4.5%, OCTOCRYLENE 3%Beiersdorf Inc0f113048-adfb-7d2a-e063-6294a90a20122025-12-17WarningsExact identifier
application number: M020
Coppertone Oil Free and Shine Control Face Sunscreen SPF 45AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Incf3d163b4-6774-4c2e-e053-2a95a90afd592025-12-17WarningsExact identifier
application number: M020
Coppertone EveryTone Face Sunscreen SPF 55AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc04b12f39-778c-ecee-e063-6394a90afa242025-12-17WarningsExact identifier
application number: M020
Skin On Skin BC Foundation SPF 40 - Fair CoolOCTISALATE, HOMOSALATE, ZINC OXIDEYENSA Beauty, LLC462e9a4a-ef28-0e0e-e063-6394a90ab4f82025-12-17WarningsExact identifier
application number: M020
Mattifying Primer SPF 20TITANIUM DIOXIDE AND ZINC OXIDEColorescienceb27d7df0-3c84-4cc5-9ef3-07105311fed92025-12-17WarningsExact identifier
application number: M020
Cetaphil Redness Relieving Daily Facial Moisturizer with sunscreen SPF 40TITANIUM DIOXIDE, ZINC OXIDEGalderma Laboratories, L.P.45d101be-2b88-4759-9ccc-556f5ec0553d2025-12-17WarningsExact identifier
application number: M020
Brightening Primer SPF 20TITANIUM DIOXIDE AND ZINC OXIDEColoresciencea42d6761-47cd-4c9b-9656-64e37e0656392025-12-17WarningsExact identifier
application number: M020
Avail Body with SunscreenHOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONEEmeis Cosmetics Pty Ltd4bb39ea1-f948-4357-b425-0cafd454ce302025-12-17WarningsExact identifier
application number: M020
Bronzing Primer SPF 20TITANIUM DIOXIDE AND ZINC OXIDEColoresciencef749af07-0fcd-4376-be62-7c078b3e7eb62025-12-17WarningsExact identifier
application number: M020
Miffy Tone Perfecting SPF CushionHOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDERBGROUP Co., Ltd98a2906d-61e2-4627-a695-a20f10872f9a2025-12-16WarningsExact identifier
application number: M020
Dear Sun Tone Perfecting SPF CushionHOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDERBGROUP Co., Ltd80748647-e0ea-46dc-8ee2-a0ad77c4b19d2025-12-16WarningsExact identifier
application number: M020
SUNSCREEN StickZINC OXIDE 15%, TITANIUM DIOXIDE 8%, HOMOSALATE 6%Foshan Sugar Max Cosmetics CO.,Ltd460e1038-30f0-a6e4-e063-6394a90ad5342025-12-16WarningsExact identifier
application number: M020
SUNSCREEN SPRAY150mlZINC OXIDE 15%, TITANIUM DIOXIDE 6%, HOMOSALATE 5%, OCTISALATE 4%Foshan Sugar Max Cosmetics CO.,Ltd460ead6c-dd44-e320-e063-6294a90a2b642025-12-16WarningsExact identifier
application number: M020
Sunscreen CreamZINC OXIDE 12%,TITANIUM DIOXIDE 8%, HOMOSALATE 12%, OCTISALATE4.5%,PHENYLBENZIMIDAZOLE SULFONIC ACID 3.5%Foshan Sugar Max Cosmetics CO.,Ltd460f0ca0-9440-9a6e-e063-6394a90a33b32025-12-16WarningsExact identifier
application number: M020
Unseen Sunscreen Lip Protector SPF 30OCTOCRYLENE, AVOBENZONE, HOMOSALATE, OCTISALATESupergoop LLCdb12a89f-5fef-1b2a-e053-2a95a90a56f92025-12-16WarningsExact 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