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 35 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
THANKYOU FARMER Sun Project Soothing Sun	OCTISALATE, OCTINOXATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATE	THANK YOU FARMER CO., LTD	300ab1bc-9c11-c2f0-e063-6394a90aa853	2026-05-06	Warnings	Exact identifier application number: M020
Sheer Defense Tinted Broad Spectrum Sunscreen SPF 50	ZINC OXIDE, OCTINOXATE	Private Label Skin Care	9eb7f287-cb61-4f9d-968e-16b195dbbc9a	2026-05-06	Warnings	Exact identifier application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 1W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	53a79ee7-312b-49a2-8a9b-c50794fcd171	2026-05-05	Warnings	Exact identifier application number: M020
SPF 50 Dry Tropix with fragrance	HOMOSALATE 10.00% OCTISALATE 5.00% AVOBENZONE 3.00%	Surface Products Corp	2c95f5c0-7ff6-4eac-b2d6-49e7da7e7bec	2026-05-05	Warnings	Exact identifier application number: M020
SURFACE SUN SPF30 DRY TOUCH Fragrance Free	HOMOSALATE 10.00% OCTOCRYLENE 6.00% AVOBENZONE 3.00%	Surface Products Corp	9592835a-7c07-487e-a955-04fdea070809	2026-05-05	Warnings	Exact identifier application number: M020
SURFACE SUN SPF 50 DRY TOUCH Fragrance Free	HOMOSALATE 10.00% OCTOCRYLENE 6.00% AVOBENZONE 3.00%	Surface Products Corp	65f52fc8-8ddb-4282-9bc0-92a7d0e0c0f2	2026-05-05	Warnings	Exact identifier application number: M020
Knesko Skin The Sunscreen	ZINC OXIDE	Knesko, LLC	5114dc75-a865-326e-e063-6294a90a8911	2026-05-05	Warnings	Exact identifier application number: M020
SURFACE SUN SPF 50 DRY TOUCH Fragrance Free	HOMOSALATE 10.00% OCTOCRYLENE 6.00% AVOBENZONE 3.00%	Surface Products Corp	683cb489-e4e1-44ab-9543-614d42b08edd	2026-05-05	Warnings	Exact identifier application number: M020
Neutrogena MINERAL UV TINT FACE DEEP SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Port Jervis Laboratories, Inc	51169bed-2091-ad2b-e063-6294a90a84b6	2026-05-05	Warnings	Exact identifier application number: M020
Surface Sun SPF 50 Mineral Sunscreen	ZINC OXIDE 24%	Surface Products Corp	6f95de43-cb71-4ddd-b438-a35ee2e14fae	2026-05-05	Warnings	Exact identifier application number: M020
Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Port Jervis Laboratories, Inc	5118a0a4-728b-6884-e063-6394a90a02b3	2026-05-05	Warnings	Exact identifier application number: M020
Carmex Daily Care Moisturizing Lip Balm Strawberry SPF 15	OCTINOXATE, OXYBENZONE	Carma Laboratories, Inc.	baed7205-2e0d-c6aa-e053-2995a90a8e29	2026-05-05	Warnings	Exact identifier application number: M020
Carmex Daily Care Moisturizing Lip Balm Strawberry SPF 15	OCTINOXATE, OXYBENZONE	Carma Laboratories, Inc.	baee366f-c1a0-5e21-e053-2a95a90a6687	2026-05-05	Warnings	Exact identifier application number: M020
Carmex Sun and Soothe Moisturizing Lip Balm SPF 30	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Carma Laboratories, Inc.	fc4d2387-ce6a-4105-bab4-7d371b61f770	2026-05-05	Warnings	Exact identifier application number: M020
THANKYOU FARMER Sun Project Soothing Sun	HOMOSALATE, OCTISALATE. AVOBENZONE	THANK YOU FARMER CO., LTD	3009df84-4ca7-e170-e063-6294a90a1578	2026-05-05	Warnings	Exact identifier application number: M020
THANKYOU FARMER Sun Project Moisture Sun	HOMOSALATE, OCTOCRYLENE, OCTISALATE, OCTINOXATE, AVOBENZONE	THANK YOU FARMER CO., LTD	300d8526-0daf-2255-e063-6394a90a21b1	2026-05-05	Warnings	Exact identifier application number: M020
LUMINOUS EYE CORRECTOR SPF 41 - FAIR	TITANIUM DIOXIDE, ZINC OXIDE	Drmtlgy, LLC	8cfb1f8c-1bd7-4983-ab82-1c9bd8925afa	2026-05-04	Warnings	Exact identifier application number: M020
LUMINOUS EYE CORRECTOR SPF 41 - DEEP	TITANIUM DIOXIDE, ZINC OXIDE	Drmtlgy, LLC	930bd1de-5a0e-4607-8d3c-b1ca918f890b	2026-05-04	Warnings	Exact identifier application number: M020
THANKYOU FARMER Sun Project Rice Tinted Mineral Sunscreen	ZINC OXIDE	THANK YOU FARMER CO., LTD	30086b1e-d876-2528-e063-6294a90a4e9f	2026-05-04	Warnings	Exact identifier application number: M020
Blue Berry SPF 15 Broad Spectrum Lip Balm	BLUE BERRY SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	50ff6ecb-c8b3-02fc-e063-6394a90a68de	2026-05-04	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