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 164 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TuroSkin Daily Moisturizing Sunscreen broadspectrum spf15	AVOBENZONE,HOMOSALATE,OCTISALATE	Renuskin LLC	e36efd74-11c2-4850-9529-1c88b7364a33	2025-11-12	Warnings	Exact identifier application number: M020
TuroSkin Sport Sunscreen Broad Spectrum SPF 30 WR SR 80min	AVOBENZONE,HOMOSALATE,OCTISALATE	Renuskin LLC	22a40d93-ca67-4b7d-a95c-22f52cd6d297	2025-11-12	Warnings	Exact identifier application number: M020
Practical Alchemy Hydrating SPF 30	ZINC OXIDE	Over Here, LLC	2f07df5b-dbd4-494c-a7cf-55843fb4d7c2	2025-11-12	Warnings	Exact identifier application number: M020
Dr Lift SPF 50 Mineral Sunscreen Stick	ZINC OXIDE	Spa de Soleil	436fdf4f-11db-7c5b-e063-6294a90a8731	2025-11-12	Warnings	Exact identifier application number: M020
CeraVe Developed with Dermatologists Skin Renewing Brightening with Sunscreen Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	L'Oreal USA Products Inc	3676aa91-c90d-4a7a-b02e-d5b35304a04d	2025-11-12	Warnings	Exact identifier application number: M020
HYDRATING GLOW MIST SPF 50	AVOBENZONE, OCTISALATE, OCTOCRYLENE	NAKED SUNDAYS PTY LTD	df3bd18d-63b4-460f-bf1c-115ad35edd96	2025-11-11	Warnings	Exact identifier application number: M020
Zinka Clear Zinc Oxide Sunscreen	OCTINOXATE, ZINC OXIDE, OCTISALATE, OXYBENZONE	Zinka, Inc.	7b097f5e-8127-49e6-8a77-4ee1fded5ff1	2025-11-11	Warnings	Exact identifier application number: M020
Total Sun Protection	OCTINOXATE, OCTISALATE, OXYBENZONE, ZINC OXIDE	Cosmed Dermaceuticals, Inc.	dbb16ef1-ab8c-4e71-a2a2-a507d104ff0f	2025-11-11	Warnings	Exact identifier application number: M020
Sunsorb Reef Safe SPF15	HOMOSALATE, OCTOCRYLENE, AVOBENZONE	QS Key West Aloe, LLC	1a1c17c4-4912-4573-9f59-cbd14a014cb4	2025-11-11	Warnings	Exact identifier application number: M020
Sunsorb Reef Safe SPF30	HOMOSALATE, OCTOCRYLENE, AVOBENZONE	QS Key West Aloe, LLC	14f65b3d-90bf-4689-aa6e-879e06153db9	2025-11-11	Warnings	Exact identifier application number: M020
Sunsorb Reef Safe SPF50	HOMOSALATE, ZINC OXIDE, OCTOCRYLENE	QS Key West Aloe, LLC	b4fc7a51-a163-4057-8790-f2111668ec67	2025-11-11	Warnings	Exact identifier application number: M020
Dr. Idriss Major Fade Disco Block Whipped Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE	PILLOWTALKDERM LLC	30e10a62-8430-649b-e063-6394a90a97eb	2025-11-11	Warnings	Exact identifier application number: M020
Essential Defense Mineral Shield Broad Spectrum SPF 32 Sunscreen TINTED	TITANIUM DIOXIDE AND ZINC OXIDE	Allergan, Inc.	279a5214-79b2-44e9-b003-378d0b992395	2025-11-11	Warnings	Exact identifier application number: M020
Tinted Moisturizer SPF 46 Universal Tint	ZINC OXIDE, OCTINOXATE	Drmtlgy, LLC	5304b568-f891-4094-9182-363ae7bcfbe4	2025-11-11	Warnings	Exact identifier application number: M020
C Lip Serum Mineral Broad Spectrum SPF 30	SUNSCREEN	Simply Active Cosmetics	323661a6-3602-1ce2-e063-6394a90a8e91	2025-11-10	Warnings	Exact identifier application number: M020
buttah Tinted Mineral Sunscreen SPF-30	TITANIUM DIOXIDE, ZINC OXIDE	Buttah Enterprises, LLC.	43458152-0775-dd9c-e063-6394a90a6140	2025-11-10	Warnings	Exact identifier application number: M020
Aspen Glow 100% Mineral Broad Spectrum SPF 30 Powder Sunscreen 0.16 oz / 4.6 g	ZINC OXIDE	Aspen Glow Cosmetics, LLC	142eda44-76e1-7960-e063-6394a90a9ad6	2025-11-10	Warnings	Exact identifier application number: M020
TriLipiderm Broad Spectrum SPF 30	BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL METHOXYCINNAMATE, HOMOSALATE, OCTOCRYLENE	TriLipid Research Institute, LLC	617fc696-c2a1-4855-bafb-0454e6497101	2025-11-10	Warnings	Exact identifier application number: M020
TriLipiderm Protective Day	HOMOSALATE, ETHYLHEXYL METHOXYCINNAMATE,BUTYL METHOXYDIBENZOYLMETHANE, OCTOCRYLENE	TriLipid Research Institute, LLC	66726c2b-27e9-5dd1-e053-2991aa0a1ba7	2025-11-10	Warnings	Exact identifier application number: M020
Eucerin Sensitive Mineral SPF 50 Sunscreen	ZINC OXIDE	Beiersdorf Inc	cdb25154-e4e3-efc7-e053-2a95a90a2df6	2025-11-10	Warnings	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