Algenist

Product NDC: 53407-104
11-digit product format: 534070104
Labeler code: 53407
Product ID: 53407-104_832dd2f9-b7a0-448d-ae64-74dc01d5fe3e
Type: HUMAN OTC DRUG
Nonproprietary name: Avobenzone, Homosalate, Octisalate
Dosage form: CREAM
Route: TOPICAL
Labeler: Solazyme, Inc.
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2012-08-01
Marketing end: 0000-00-00
Substance: AVOBENZONE; HOMOSALATE; OCTISALATE
Active strength: 30 mg/mL; mg/mL; mg/mL
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	53407-104		D	Discontinued by firm		2026-10-15
excluded package	package	53407-104	53407-104-60	D	Discontinued by firm		2026-10-15

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 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53407-104-60	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53407-104-60	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53407-104-60	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53407-104-60	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53407-104-60	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53407-104-60	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53407-104-60	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53407-104-60	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53407-104-60	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53407-104-60	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53407-104-60	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53407-104-60	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53407-104-60	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53407-104-60	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53407-104-60	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53407-104-60	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	53407-104-60	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	53407-104-60	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	53407-104-60	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53407-104-60	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53407-104-60	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	53407-104-60	I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53407-104-60	2025-01-17	C162847	48780-1	9855d018-e039-cd31-e053-dbdaa90ab51a	1903ca5a-2afb-4ecb-a616-537864c72612
53407-104-60	2019-11-27	C162847	48780-1	9855d018-e039-cd31-e053-dbdaa90ab51a	1903ca5a-2afb-4ecb-a616-537864c72612

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Avobenzone	ACTIVE INGREDIENT	G63QQF2NOX	ALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]	3
Homosalate	ACTIVE INGREDIENT	V06SV4M95S	ALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]	3
Octisalate	ACTIVE INGREDIENT	4X49Y0596W	ALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]	3
Avobenzone	ACTIVE MOIETY	G63QQF2NOX	ALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]	3
Homosalate	ACTIVE MOIETY	V06SV4M95S	ALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]	3
Octisalate	ACTIVE MOIETY	4X49Y0596W	ALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]	3
ALARIA ESCULENTA	INACTIVE INGREDIENT	EJ9JK8J58D	ALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]	3
AMINOMETHYLPROPANOL	INACTIVE INGREDIENT	LU49E6626Q	ALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]	3
ANNICKIA CHLORANTHA BARK	INACTIVE INGREDIENT	H70115MP4A	ALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]	3
APPLE	INACTIVE INGREDIENT	B423VGH5S9	ALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]	3
Biotin	INACTIVE INGREDIENT	6SO6U10H04	ALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]	3
Butylene Glycol	INACTIVE INGREDIENT	3XUS85K0RA	ALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]	3
caprylyl glycol	INACTIVE INGREDIENT	00YIU5438U	ALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]	3
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)	INACTIVE INGREDIENT	Z135WT9208	ALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]	3
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	ALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]	3
Cetyl Phosphate	INACTIVE INGREDIENT	VT07D6X67O	ALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]	3
DI-C12-15 ALKYL FUMARATE	INACTIVE INGREDIENT	A1CB3Z898P	ALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]	3
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	ALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]	3
EGG PHOSPHOLIPIDS	INACTIVE INGREDIENT	1Z74184RGV	ALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]	3
ERGOTHIONEINE	INACTIVE INGREDIENT	BDZ3DQM98W	ALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]	3
ethylhexylglycerin	INACTIVE INGREDIENT	147D247K3P	ALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]	3
EUCALYPTUS OIL	INACTIVE INGREDIENT	2R04ONI662	ALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]	3
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	ALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]	3
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	ALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]	3
hexylene glycol	INACTIVE INGREDIENT	KEH0A3F75J	ALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]	3
mannitol	INACTIVE INGREDIENT	3OWL53L36A	ALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]	3
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	ALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]	3
OLEANOLIC ACID	INACTIVE INGREDIENT	6SMK8R7TGJ	ALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]	3
Peg-100 Stearate	INACTIVE INGREDIENT	YD01N1999R	ALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]	3
Pentylene Glycol	INACTIVE INGREDIENT	50C1307PZG	ALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]	3
phenoxyethanol	INACTIVE INGREDIENT	HIE492ZZ3T	ALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]	3
SHEA BUTTER	INACTIVE INGREDIENT	K49155WL9Y	ALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]	3
SODIUM ASCORBYL PHOSPHATE	INACTIVE INGREDIENT	836SJG51DR	ALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]	3
stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	ALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]	3
Tetrapeptide-21	INACTIVE INGREDIENT	179JUC43HU	ALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]	3
Water	INACTIVE INGREDIENT	059QF0KO0R	ALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]	3
Xanthan Gum	INACTIVE INGREDIENT	TTV12P4NEE	ALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]	3

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE
V06SV4M95S	HOMOSALATE	118-56-9	HOMOSALATE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Algenist - Solazyme, Inc. \| PhytogenX,Inc	Solazyme, Inc. \| PhytogenX,Inc	2012-08-08	HUMAN OTC DRUG LABEL	3

Algenist

NDC auxiliary status#

Observed NDC auxiliary status history#

Reported adverse events (FAERS/openFDA)#

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

Related DailyMed Labels#