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 125 of 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Daily Restore ZINC OXIDE TYRLIN ENTERPRISES, INC. 35cead50-86a7-2cf2-e063-6294a90a5f99 2025-12-15 Exact identifier application number: M020 Daily Defense Facial Sunscreen Plus Primer TITANIUM DIOXIDE, ZINC OXIDE LAURA CATHERINE, LLC 36e81e8e-0ba7-93e6-e063-6294a90a4e62 2025-12-15 Exact identifier application number: M020 Sacred Aura ZINC OXIDE IRIA SKIN OASIS LLC 36eaaa54-e288-6590-e063-6394a90a403d 2025-12-15 Exact identifier application number: M020 Daily Defense Facial Sunscreen Plus Primer TITANIUM DIOXIDE, ZINC OXIDE LAURA CATHERINE, LLC 36e84147-5dcd-517a-e063-6394a90a54ee 2025-12-15 Exact identifier application number: M020 Sacred Glow ZINC OXIDE IRIA SKIN OASIS LLC 36ead65c-a46c-7395-e063-6394a90a9e04 2025-12-15 Exact identifier application number: M020 Sheer Mineral Face And Body Sunscreen Non Tinted ZINC OXIDE LAURA CATHERINE, LLC 36e91877-c4c4-7fa3-e063-6294a90a1326 2025-12-15 Exact identifier application number: M020 Sheer Mineral Face And Body Sunscreen Tinted ZINC OXIDE LAURA CATHERINE, LLC 36e880af-debc-657f-e063-6394a90ab6ff 2025-12-15 Exact identifier application number: M020 Sheer Mineral Face And Body Sunscreen Tinted ZINC OXIDE LAURA CATHERINE, LLC 36e8b631-03e7-c1de-e063-6294a90aa530 2025-12-15 Exact identifier application number: M020 Sheer Mineral Face And Body Sunscreen Non Tinted ZINC OXIDE LAURA CATHERINE, LLC 36e957cf-cfa5-b122-e063-6294a90a78ce 2025-12-15 Exact identifier application number: M020 Skin Shield Plus ZINC OXIDE LAURA CATHERINE, LLC 36e9c2f3-ea89-0de3-e063-6394a90a9fb6 2025-12-15 Exact identifier application number: M020 Skin Shield Plus ZINC OXIDE LAURA CATHERINE, LLC 36e9958b-cc5c-f7ff-e063-6394a90ac80d 2025-12-15 Exact identifier application number: M020 Tinted Mineral Sunscreen Plus Primer Matte TITANIUM DIOXIDE, ZINC OXIDE Simply Bare Waxing & Skin Care LLC 36d8e8ba-a3dd-257d-e063-6294a90a30d6 2025-12-15 Exact identifier application number: M020 Tinted Lip Sunscreen TITANIUM DIOXIDE, ZINC OXIDE LAURA CATHERINE, LLC 36e9e8d7-3fcf-1e94-e063-6394a90a8dc6 2025-12-15 Exact identifier application number: M020 Tinted Mineral Sunscreen Plus Primer CPlusE Glow ZINC OXIDE Simply Bare Waxing & Skin Care LLC 36d968df-5168-61bf-e063-6294a90a94b7 2025-12-15 Exact identifier application number: M020 Advanced Sun Protection TITANIUM DIOXIDE, ZINC OXIDE HELLO BEAUTIFUL SKIN STUDIO 36d45b48-e08d-ef40-e063-6394a90a635c 2025-12-15 Exact identifier application number: M020 Advanced Sun Protection TITANIUM DIOXIDE, ZINC OXIDE HELLO BEAUTIFUL SKIN STUDIO 36d439fb-b9cf-2774-e063-6294a90ae885 2025-12-15 Exact identifier application number: M020 Tinted Mineral Sunscreen Plus Primer CPlusE Glow ZINC OXIDE Simply Bare Waxing & Skin Care LLC 36d9b48d-e3db-6ae2-e063-6294a90abbf5 2025-12-15 Exact identifier application number: M020 Tinted Mineral Sunscreen Plus Primer Matte TITANIUM DIOXIDE, ZINC OXIDE Simply Bare Waxing & Skin Care LLC 36d9d83b-7da7-a006-e063-6394a90a9d84 2025-12-15 Exact identifier application number: M020 Advanced Sun Protection TITANIUM DIOXIDE, ZINC OXIDE HELLO BEAUTIFUL SKIN & ACNE 36d3ebc0-1de6-1998-e063-6294a90a02e6 2025-12-15 Exact identifier application number: M020 Sun Safe Lip Balm TITANIUM DIOXIDE, ZINC OXIDE REVIVE IN SOLANO 36c4f0c9-5789-ca58-e063-6394a90a2323 2025-12-15 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