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 168 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Aveeno Positively Radiant Daily Moisturizer Sunscreen Broad Spectrum SPF 15 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Kenvue Brands LLC dd9ebc46-0fa4-5d96-e053-2995a90a7918 2025-11-06 Warnings Exact identifier application number: M020 Hawaiian Tropic Mineral Face Skin Nourishing Tinted Milk Coconut Oil SPF30 TITANIUM DIOXIDE, ZINC OXIDE Edgewell Personal Care Brands LLC eeb3c173-b280-76e4-e053-2995a90a0e79 2025-11-06 Warnings Exact identifier application number: M020 SPF 50 Sunscreen Stick ZINC OXIDE ELEEO BRANDS LLC 09cf0f04-961e-4430-91bb-224e7fed13ef 2025-11-06 Warnings Exact identifier application number: M020 Hawaiian Tropic Mineral Skin Nourishing Milk Coconut Oil SPF 50 TITANIUM DIOXIDE, ZINC OXIDE Edgewell Personal Care Brands LLC efcd52c2-4208-46a1-e053-2a95a90a857d 2025-11-06 Warnings Exact identifier application number: M020 Peachy Mineral Facial Sunscreen ZINC OXIDE Peachy Corp 42efead0-0e11-7270-e063-6394a90a4eb9 2025-11-06 Warnings Exact identifier application number: M020 Peachy Tinted Facial Sunscreen ZINC OXIDE Peachy Corp 42f0fb68-c0bf-cf98-e063-6294a90ab703 2025-11-06 Warnings Exact identifier application number: M020 Banana Boat AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Edgewell Personal Care Brands, LLC 764401f3-4219-6e9b-e053-2991aa0a3ed2 2025-11-06 Warnings Exact identifier application number: M020 Banana Boat Sport coolzone Clear Sunscreen Broad Spectrum SPF 30 AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Edgewell Personal Care Brands LLC ab7102ba-1020-3f51-e053-2995a90ae24d 2025-11-06 Warnings Exact identifier application number: M020 Banana Boat Sunscreen Lip Balm UVA/UVB Broad Spectrum SPF 45 AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Edgewell Personal Care Brands LLC c794592c-d24e-4530-e053-2995a90a7e4d 2025-11-06 Warnings Exact identifier application number: M020 Green Envee Radiance Sheer ZINC OXIDE Green Envee 42f1908f-2787-c4e5-e063-6294a90afcd0 2025-11-06 Warnings Exact identifier application number: M020 Indie Lee Daily Primer ZINC OXIDE America Exchange 38e5232b-7daf-7e61-e063-6394a90aa5b0 2025-11-06 Warnings Exact identifier application number: M020 Duette Untinted ZINC OXIDE Skin Theory Studios 3ce24b39-8bb1-1246-e063-6294a90a32d4 2025-11-06 Warnings Exact identifier application number: M020 Duette Tinted ZINC OXIDE Skin Theory Studios 3ce1d7cb-b37d-fb9f-e063-6394a90aaef3 2025-11-06 Warnings Exact identifier application number: M020 Truskin Broad Spectrum Mineral Sunscreen Facial Serum with Vitamin C and Aloe ZINC OXIDE Allure Labs 42f3999f-4163-fadc-e063-6294a90aacf3 2025-11-06 Warnings Exact identifier application number: M020 Melan RX ZINC OXIDE Melan RX f4bdf20c-b6bc-55f1-e053-2995a90ac308 2025-11-06 Warnings Exact identifier application number: M020 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (FUCSIA CAUTIVANTE EXOTIC) - PINK OCTINOXATE AND OXYBENZONE Ventura Corporation LTD e1eb77f1-d65c-4af8-a7d9-90f10570960f 2025-11-06 Warnings Exact identifier application number: M020 Ultraceuticals Ultra UV Protective Daily Moisturising ZINC OXIDE Ultraceuticals fc8a5c02-23b4-b4d8-e053-6294a90a55ea 2025-11-06 Warnings Exact identifier application number: M020 Vaihea Protect Clean SPF Drops ZINC OXIDE Vaihea Skincare LLC fe7e3145-a8e2-d14f-e053-6394a90abb5e 2025-11-06 Warnings Exact identifier application number: M020 Refy Skin Trio ZINC OXIDE Refy 3029a690-dbb0-ff15-e063-6394a90abdbe 2025-11-06 Warnings Exact identifier application number: M020 Stream2Sea Broad Spectrum 20 TITANIUM DIOXIDE Stream2Sea, LLC 1775d07d-6914-6928-e054-00144ff88e88 2025-11-06 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