Home NDC 53407-138 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 date Dataset Scope Package NDC Snapshot Source SHA-256 2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 53407-138-30 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 53407-138-30 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 53407-138-30 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 53407-138-30 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 53407-138-30 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 53407-138-30 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 53407-138-30 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 53407-138-30 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 53407-138-30 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 53407-138-30 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 53407-138-30 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 53407-138-30 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 53407-138-30 110d247fa046…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 Ingredient Strength OCTINOXATE 75 mg/mL TITANIUM DIOXIDE 20 mg/mL ZINC OXIDE 171 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4Y5P7MUD51 Internal UNII lookup 15FIX9V2JP Internal UNII lookup SOI2LOH54Z Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53407-138-30 Algenist 1 in 1 BOX CREAM 1 4 53407-138-30 Algenist 1 in 1 CARTON CREAM 1 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Octinoxate ACTIVE INGREDIENT 4Y5P7MUD51 ALGENIST (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SOLAZYME, INC.] 2 Titanium Dioxide ACTIVE INGREDIENT 15FIX9V2JP ALGENIST (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SOLAZYME, INC.] 2 Zinc Oxide ACTIVE INGREDIENT SOI2LOH54Z ALGENIST (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SOLAZYME, INC.] 2 Octinoxate ACTIVE MOIETY 4Y5P7MUD51 ALGENIST (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SOLAZYME, INC.] 2 Titanium Dioxide ACTIVE MOIETY 15FIX9V2JP ALGENIST (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SOLAZYME, INC.] 2 Zinc Oxide ACTIVE MOIETY SOI2LOH54Z ALGENIST (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SOLAZYME, INC.] 2 .ALPHA.-TOCOPHEROL ACETATE INACTIVE INGREDIENT 9E8X80D2L0 ALGENIST (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SOLAZYME, INC.] 2 alcohol INACTIVE INGREDIENT 3K9958V90M ALGENIST (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SOLAZYME, INC.] 2 aluminum hydroxide INACTIVE INGREDIENT 5QB0T2IUN0 ALGENIST (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SOLAZYME, INC.] 2 ARCTOSTAPHYLOS UVA-URSI LEAF INACTIVE INGREDIENT 3M5V3D1X36 ALGENIST (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SOLAZYME, INC.] 2 camellia oleifera seed INACTIVE INGREDIENT 59ED29FM2J ALGENIST (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SOLAZYME, INC.] 2 caprylyl glycol INACTIVE INGREDIENT 00YIU5438U ALGENIST (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SOLAZYME, INC.] 2 CYCLOMETHICONE 5 INACTIVE INGREDIENT 0THT5PCI0R ALGENIST (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SOLAZYME, INC.] 2 echinacea purpurea INACTIVE INGREDIENT QI7G114Y98 ALGENIST (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SOLAZYME, INC.] 2 ethylhexylglycerin INACTIVE INGREDIENT 147D247K3P ALGENIST (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SOLAZYME, INC.] 2 glycerin INACTIVE INGREDIENT PDC6A3C0OX ALGENIST (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SOLAZYME, INC.] 2 GLYCYRRHIZA GLABRA INACTIVE INGREDIENT 2788Z9758H ALGENIST (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SOLAZYME, INC.] 2 hexylene glycol INACTIVE INGREDIENT KEH0A3F75J ALGENIST (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SOLAZYME, INC.] 2 METHYL METHACRYLATE INACTIVE INGREDIENT 196OC77688 ALGENIST (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SOLAZYME, INC.] 2 peg/ppg-18/18 dimethicone INACTIVE INGREDIENT 9H0AO7T794 ALGENIST (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SOLAZYME, INC.] 2 phenoxyethanol INACTIVE INGREDIENT HIE492ZZ3T ALGENIST (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SOLAZYME, INC.] 2 stearic acid INACTIVE INGREDIENT 4ELV7Z65AP ALGENIST (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SOLAZYME, INC.] 2 water INACTIVE INGREDIENT 059QF0KO0R ALGENIST (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SOLAZYME, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53407-138 ALGENIST (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SOLAZYME, INC.] 4 Current NDC, Legacy NDC, 2 package rows 20250424_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 180 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Premium Moisturizing Sunscreen Broad Spectrum SPF 15 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Wasatch Product Development, LLC f4346f7a-3642-05d8-e053-2a95a90a013d 2025-10-09 Warnings Exact identifier application number: M020 Premium Moisturizing Sunscreen Broad Spectrum SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Wasatch Product Development, LLC f4206dad-6a17-2f56-e053-2a95a90a69dc 2025-10-09 Warnings Exact identifier application number: M020 Premium Moisturizing Sunscreen Broad Spectrum SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Wasatch Product Development, LLC f434089c-126f-441c-e053-2995a90ab0c7 2025-10-09 Warnings Exact identifier application number: M020 BEAUTY SHIELD BROAD SPECTRUM SUNSCREEN (Napoleon Perdis) ZINC OXIDE Napoleon PerdisCosmetic Pty Ltd be64bb40-b1a9-2308-e053-2a95a90a69c8 2025-10-09 Warnings Exact identifier application number: M020 Organys Open Formula Sheer ZINC OXIDE Organys Beauty 0b3ab551-cb66-cf86-e063-6394a90a7ab4 2025-10-09 Warnings Exact identifier application number: M020 Dr Lift Mineral SPF 50 TITANIUM DIOXIDE, ZINC OXIDE Spa de Soleil 40c03d65-8d09-371a-e063-6294a90a7ac6 2025-10-09 Warnings Exact identifier application number: M020 Organys Derma Made Sheer ZINC OXIDE Organys Beauty 0b39f550-bd34-509d-e063-6294a90a51d0 2025-10-09 Warnings Exact identifier application number: M020 Organys Derma Made ZINC OXIDE Organys Beauty 0b37a73b-73ca-501f-e063-6294a90a6291 2025-10-09 Warnings Exact identifier application number: M020 Organys Derma Made ZINC OXIDE Organys Beauty 09b8b8c0-4066-9cbe-e063-6394a90aca24 2025-10-09 Warnings Exact identifier application number: M020 Dr Lift Mineral SPF 30 TITANIUM DIOXIDE Spa de Soleil 40c0e0d2-2c1d-e629-e063-6394a90a5aaf 2025-10-09 Warnings Exact identifier application number: M020 Daybird Tinted Skincare (SHADE 3) ZINC OXIDE Resette, Inc dc89ab76-da32-4f6f-e053-2995a90a8bcb 2025-10-09 Warnings Exact identifier application number: M020 Daybird Tinted Skincare (SHADE 4) ZINC OXIDE Resette, Inc dc89ab0b-d53e-983f-e053-2a95a90a127f 2025-10-09 Warnings Exact identifier application number: M020 Petroleum-Free Lip Balm OCTINOXATE AND OXYBENZONE Medline Industries, LP 6125d98a-6fc7-4f50-924e-3b1f7ee951f4 2025-10-09 Warnings Exact identifier application number: M020 Daybird Tinted Skincare (SHADE 1) ZINC OXIDE Resette, Inc dc89429a-022c-dd10-e053-2a95a90ac26a 2025-10-09 Warnings Exact identifier application number: M020 Daybird Tinted Skincare (SHADE 2) ZINC OXIDE Resette, Inc dc89ab76-da2f-4f6f-e053-2995a90a8bcb 2025-10-09 Warnings Exact identifier application number: M020 Dr Lift SPF 50 Clear Stick AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Spa de Soleil 40c11b19-fc91-2033-e063-6394a90a5a5f 2025-10-09 Warnings Exact identifier application number: M020 Black Girl Sunscreen Make It Mineral Baby ZINC OXIDE Black Girl Sunscreen 302bccc6-7bf3-cc69-e063-6294a90a625c 2025-10-09 Warnings Exact identifier application number: M020 Babo Botanicals Sheer Zinc Mineral Sunscreen SPF30 ZINC OXIDE Babo Botanicals, Inc. 08f0436b-85b6-5099-e063-6294a90a4c2e 2025-10-09 Warnings Exact identifier application number: M020 CoreTex Professional Outdoor Skin Protection Wallet CORETEX PROFESSIONAL OUTDOOR SKIN PROTECTION WALLET CoreTex Products Inc f57bc089-405b-cdcd-e053-2995a90a9d12 2025-10-09 Warnings Exact identifier application number: M020 Mist Me SPF-40 ZINC OXIDE Cove Suncare LLC b7f09089-54a4-4f60-b632-e3f4321313ec 2025-10-09 Warnings Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 53407-138-30 53407013830 1 CARTON in 1 BOX (53407-138-30) / 1 JAR in 1 CARTON / 30 mL in 1 JAR 1 carton 2012-08-01 No No Current