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 130 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Satin Tint	ZINC OXIDE	Brent Loftis, D.O., Inc., A California Medical Corporation	359684cf-ca11-f9af-e063-6394a90ac4c1	2025-12-12		Exact identifier application number: M020
TINTED MINERAL SUNSCREEN SPF 40	TITANIUM DIOXIDE, ZINC OXIDE	DERMATOLOGY ARTS	35814d5d-fd34-05b3-e063-6294a90aadd1	2025-12-12		Exact identifier application number: M020
JAYSUING Rice Probiotics Sunscreen	TITANIUM DIOXIDE	Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.	45cdc741-9ce0-fd6c-e063-6294a90adc0b	2025-12-12	Warnings	Exact identifier application number: M020
Tinted Lip Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	LA HAIR DESIGN	36eb4cd3-778c-362f-e063-6294a90a059c	2025-12-11		Exact identifier application number: M020
Matte Finish	TITANIUM DIOXIDE, ZINC OXIDE	CLEAN BEAUTY BY ANAK LLC	37630c6c-f768-7b3e-e063-6394a90af565	2025-12-11		Exact identifier application number: M020
Signature Tint SPF 40	ZINC OXIDE	ADVANCED AESTHETICS SKIN CARE STUDIO, INC	348f1bd3-1245-2d9a-e063-6394a90a4787	2025-12-11		Exact identifier application number: M020
Mineral Lip Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	ADVANCED AESTHETICS SKIN CARE STUDIO, INC	348fcc63-d8e3-90a1-e063-6294a90ade11	2025-12-11		Exact identifier application number: M020
Tinted Sunscreen	ZINC OXIDE	Scottsdale Skin Boutique and Dermatology Pllc	34a54441-c741-0c46-e063-6294a90a9be8	2025-12-11		Exact identifier application number: M020
Instant Glow	ZINC OXIDE	CLEAN BEAUTY BY ANAK LLC	37620171-140d-e096-e063-6294a90af93b	2025-12-11		Exact identifier application number: M020
Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Scottsdale Skin Boutique Aesthetics Pllc	34a49563-c74b-2fd1-e063-6394a90a6c56	2025-12-11		Exact identifier application number: M020
Tinted Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Scottsdale Skin Boutique and Dermatology Pllc	34a52011-b781-75cf-e063-6394a90ae0f4	2025-12-11		Exact identifier application number: M020
Tinted Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Scottsdale Skin Boutique and Dermatology Pllc	34a632f5-4458-e335-e063-6394a90a9bcb	2025-12-11		Exact identifier application number: M020
D FEND DAILY	ZINC OXIDE	CLEAN BEAUTY BY ANAK LLC	3762dc16-055e-43fd-e063-6394a90ad3c8	2025-12-11		Exact identifier application number: M020
Tinted Sunscreen	ZINC OXIDE	Scottsdale Skin Boutique and Dermatology Pllc	34a66140-0d36-005a-e063-6394a90a2a0b	2025-12-11		Exact identifier application number: M020
Instant Glow	ZINC OXIDE	CLEAN BEAUTY BY ANAK LLC	37634726-fb70-f209-e063-6294a90a5d3b	2025-12-11		Exact identifier application number: M020
Matte Finish	TITANIUM DIOXIDE, ZINC OXIDE	CLEAN BEAUTY BY ANAK LLC	3761d74c-0137-0c75-e063-6394a90a3c7d	2025-12-11		Exact identifier application number: M020
Sun Plus Sun Lip Shield	TITANIUM DIOXIDE, ZINC OXIDE	CLEAN BEAUTY BY ANAK LLC	3763a79a-e881-cade-e063-6394a90a49de	2025-12-11		Exact identifier application number: M020
Tinted Minerals 1point8 oz	TITANIUM DIOXIDE, ZINC OXIDE	SPECKTRA6 LLC	374e53c6-307f-f8e5-e063-6394a90a07ef	2025-12-11		Exact identifier application number: M020
Tinted Minerals 1point8 oz	TITANIUM DIOXIDE, ZINC OXIDE	SPECKTRA6 LLC	373e29f1-d665-a3c4-e063-6294a90a403e	2025-12-11		Exact identifier application number: M020
Non Tinted Mineral Sunscreen	ZINC OXIDE	SPECKTRA6 LLC	374e1c8e-5c5c-9198-e063-6294a90a3b88	2025-12-11		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