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 11 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MEDICUBE PDRN SILKY SUNSCREEN	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	APR US INC	57154bec-6714-0314-e063-6294a90a4bd0	2026-07-20	Warnings	Exact identifier application number: M020
TOCOBO Double UV Defense Set	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	PICTON Co., Ltd.	56aff65a-aa08-dc3f-e063-6294a90acac3	2026-07-19	Warnings	Exact identifier application number: M020
THE SPORTO Invisible Sport for Body	AVOBENZONE, OCTISALATE, AND OCTOCRYLENE	Dune Suncare, Inc.	46564a09-909d-bcc7-e063-6294a90a627b	2026-07-17	Warnings	Exact identifier application number: M020
RR Sun Creme	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Undefined Inc	dc60b685-a7fc-47bb-ade9-44a8e3b54812	2026-07-17	Warnings	Exact identifier application number: M020
Cetaphil Tinted Daily Facial Moisturizer SPF 50	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	Galderma Laboratories, L.P.	0ef2ebae-7198-47f4-8891-d1ca3cf54d4b	2026-07-16	Warnings	Exact identifier application number: M020
Mederma Scar Cream	AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE	PMI Branded Pharmaceuticals, Inc.	f9be5adb-dce3-4b17-939f-d80d486f2cb0	2026-07-16	Warnings	Exact identifier application number: M020
BaseLife Pure Mineral Shield Sunscreen	ZINC OXIDE	Wintech America, Inc.	7f741a91-6ed8-4d08-9196-d15527d044d5	2026-07-15	Warnings	Exact identifier application number: M020
BaseLife Clear UV Defense Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Wintech America, Inc.	128db446-93ba-4347-bd39-66177572c659	2026-07-15	Warnings	Exact identifier application number: M020
Biore Aqua Rich Facial Mist SPF 50	OCTOCRYLENE, OCTISALATE, AVOBENZENE, HOMOSALATE	Kao USA Inc.	56a80a0d-b0b5-1098-e063-6294a90a5270	2026-07-15	Warnings	Exact identifier application number: M020
Anti Aging Lip Balm Pot SPF 15	LIP BALM	Epicuren Disocovery	4097e28a-ed11-e16a-e063-6294a90a5e9b	2026-07-14	Warnings	Exact identifier application number: M020
HolyCow Mineral Tallow Sunscreen Face and Body SPF 50	ZINC OXIDE	CALM ENTERPRISE LLC	722462d8-d2ab-44ce-9065-673ab2076269	2026-07-14	Warnings	Exact identifier application number: M020
X-Treme Cream Propolis Sunscreen SPF 45	X-TREME CREAM	Epicuren Discovery	3b29976e-eee0-b978-e063-6294a90accd6	2026-07-14	Warnings	Exact identifier application number: M020
Anti-Aging Lip Balm SPF 15	LIP BALM	Epicuren Discovery	3cbd0550-b6e5-3e86-e063-6394a90ac07f	2026-07-14	Warnings	Exact identifier application number: M020
Zinc Oxide Perfecting Sunscreen	ZINC OXIDE	Epicuren Discovery	1a0228f9-bf3f-a1fe-e063-6294a90a3fb5	2026-07-14	Warnings	Exact identifier application number: M020
Vacation Face	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Vacation INC.	14b8a3cf-031c-4c52-ba81-e683e69d0f37	2026-07-14	Warnings	Exact identifier application number: M020
Mederma Scar Cream	AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE	L. Perrigo Company	bd5c9df7-8dfb-4d20-9966-e148c5667b22	2026-07-14	Warnings	Exact identifier application number: M020
Sun Juice Body Mist Sunscreen SPF30 - Watermelon Sugar PARADISO	AVOBENZONE, HOMOSALATE, OCTISALATE	Koco Life LLC	4081a4ad-b738-5fb6-e063-6394a90a9171	2026-07-13	Warnings	Exact identifier application number: M020
Sun Juice Body Mist Sunscreen SPF30 - Coconut Cream PARADISO	AVOBENZONE, HOMOSALATE, OCTISALATE	Koco Life LLC	3cc5c1d8-91f8-8ad2-e063-6294a90a9229	2026-07-13	Warnings	Exact identifier application number: M020
Olay Super Serum Body Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	The Procter & Gamble Manufacturing Company	5513c5e2-3baf-2f09-e063-6394a90a495a	2026-07-13	Warnings	Exact identifier application number: M020
Sun Juice Body Mist Sunscreen SPF30 - Peach Sky PARADISO	AVOBENZONE, HOMOSALATE, OCTISALATE	Koco Life LLC	3cc48592-f70d-664e-e063-6294a90ac6e8	2026-07-13	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