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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4ece1847-1c94-4bf7-b936-109556a460a7	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53407-138-30	2025-01-09	C162847	48780-1	9855d018-d637-cd31-e053-dbdaa90ab51a	Drug Facts
53407-138-30	2019-11-27	C162847	48780-1	9855d018-d637-cd31-e053-dbdaa90ab51a	Drug Facts

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
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 6 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Stay Ageless Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	CORBY, JR., TERRY L.	594443fd-8e27-4ec6-e063-6294a90a3ff0	2026-08-17	Warnings	Exact identifier application number: M020
Meraki Protective Mist Sunscreen	BROAD SPECTRUM SPF 30	MERAKI MEDICAL SPA LLC	59446224-0e97-ae2c-e063-6394a90a2a65	2026-08-17	Warnings	Exact identifier application number: M020
Sun Zapper - Acne Pure Zinc Sunscreen SPF50	ZINC OXIDE	Veganic SKN Limited	3ee435a5-70fb-0c8a-e063-6394a90a650a	2026-08-16	Warnings	Exact identifier application number: M020
Sun Zapper - Anti-ageing pure zinc sunscreen SPF30	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	3f1dc3b2-c289-5996-e063-6394a90ac622	2026-08-16	Warnings	Exact identifier application number: M020
ISNTREE HYALURONIC ACID SENSITIVE SUNSCREEN	ZINC OXIDE	ISNTREE Inc.	58e38665-0bca-fb02-e063-6394a90ad62a	2026-08-13	Warnings	Exact identifier application number: M020
Neutrogena Ultra Sheer Daily Face Sunscreen Broad Spectrum SPF 70	AVOBENZONE, BEMOTRIZINOL, HOMOSALATE, OCTISALATE	Kenvue Brands LLC	58d3d390-8b88-a6fe-e063-6394a90a9bf8	2026-08-12	Warnings	Exact identifier application number: M020
Neutrogena Clear Face Sunscreen Acne Prone Skin Broad Spectrum SPF 60	AVOBENZONE, BEMOTRIZINOL, HOMOSALATE, OCTISALATE	Kenvue Brands LLC	58d7a3e3-b7df-43ce-e063-6294a90a729c	2026-08-12	Warnings	Exact identifier application number: M020
HEB 50 Marigold Scent Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B.	58dafa24-24d5-aeb4-e063-6394a90a3c25	2026-08-12	Warnings	Exact identifier application number: M020
TESALOVA Coconut SPF 30 Lip Balm SPF 30	AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE	Tesalova Viktoriia PMU LLC	58dbb9f1-cfb3-62ac-e063-6394a90a6106	2026-08-12	Warnings	Exact identifier application number: M020
Elta MD Skincare UV Stick Broad Spectrum SPF50	ZINC OXIDE	CP Skin Health Group, Inc	58dd81db-46d4-d763-e063-6394a90abb0b	2026-08-12	Warnings	Exact identifier application number: M020
Basin Coconut SPF 30 Lip Balm SPF 30	AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE	Retail Concepts of Minnesota, Inc.	4a8e93a6-dcf9-3687-e063-6394a90a73ac	2026-08-12	Warnings	Exact identifier application number: M020
UV Skin Recovery SPF 50 Red Correcting	ZINC OXIDE	CP Skin Health Group, Inc.	26e63890-d1af-d171-e063-6394a90af828	2026-08-12	Warnings	Exact identifier application number: M020
UV Skin Recovery SPF 50	ZINC OXIDE	CP Skin Health Group, Inc.	26d2683f-cfd5-50fd-e063-6394a90a7576	2026-08-12	Warnings	Exact identifier application number: M020
doTERRA Sun Body	MINERAL SUNSCREEN	doTERRA International, LLC	58dcc56f-f093-469c-e063-6394a90a6088	2026-08-12	Warnings	Exact identifier application number: M020
Sonage Protec Plus SPF 30 Mineral Sunscreen	ZINC OXIDE	ASA Universal Inc. dba: Sonage	d92fc1df-bbeb-592a-e053-2a95a90a6951	2026-08-12	Warnings	Exact identifier application number: M020
Colorescience Total Protection Body Shield Glow	ZINC OXIDE	Colorescience	52e1d987-a4f8-195e-e063-6294a90a5629	2026-08-11	Warnings	Exact identifier application number: M020
Stay Ageless Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	DR. SAMRAO'S OFFICE	58b2ca35-11ed-d848-e063-6294a90a5b37	2026-08-11	Warnings	Exact identifier application number: M020
Ciele Tint and Protect	ZINC OXIDE	Ciele	0162d9c9-07fa-9210-e063-6294a90aa687	2026-08-11	Warnings	Exact identifier application number: M020
NeoStrata Skin Active Matrix Support SPF 30	AVOBENZONE, OCTINOXATE, AND OCTISALATE	NeoStrata Company Inc.	8e4b9c08-b906-4c5f-a243-55838ae28b90	2026-08-10	Warnings	Exact identifier application number: M020
Sunscreen for Kids SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE	The Kroger Co.	1c7cd904-ffff-48aa-91bd-cc978946b36a	2026-08-10	Warnings, Adverse reactions	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

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