PHOTO DYNAMIC THERAPY SPF 30

Product NDC: 65113-2432
11-digit product format: 651132432
Labeler code: 65113
Product ID: 65113-2432_2daef8de-6967-4615-ac7a-200ed03e61e4
Type: HUMAN OTC DRUG
Nonproprietary name: AVOBENZONE, OCTINOXATE, OCTISALATE, and OXYBENZONE
Dosage form: LOTION
Route: TOPICAL
Labeler: G.S. COSMECEUTICAL USA, INC.
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2010-10-01
Marketing end: 0000-00-00
Substance: AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE
Active strength: 3 g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag: E
Listing certified through: 2018-12-31
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	65113-2432		I	Inactivated by FDA		2026-10-05
excluded package	package	65113-2432	65113-2432-1	I	Inactivated by FDA		2026-10-05

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		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65113-2432-1	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65113-2432-1	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65113-2432-1	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65113-2432-1	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65113-2432-1	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65113-2432-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65113-2432-1	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	65113-2432-1	I	Inactivated by FDA	`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	65113-2432-1	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	65113-2432-1	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	65113-2432-1	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	65113-2432-1	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	65113-2432-1	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	65113-2432-1	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	65113-2432-1	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	65113-2432-1	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	65113-2432-1	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	65113-2432-1	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	65113-2432-1	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	65113-2432-1	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	65113-2432-1	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	65113-2432-1	E	Excluded after deficient or non-compliant submission was not corrected	`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
65113-2432-1	2020-01-31	C162847	48780-1	9d75b9cf-d946-f424-e053-dadaa90a57ce	PHOTO DYNAMIC therapy™

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65113-2432-1	PHOTO DYNAMIC THERAPY SPF 30	30 mL in 1 BOTTLE, PUMP	LOTION	30		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AVOBENZONE	ACTIVE INGREDIENT	G63QQF2NOX	PHOTO DYNAMIC THERAPY SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [G.S. COSMECEUTICAL USA, INC.]	1
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	PHOTO DYNAMIC THERAPY SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [G.S. COSMECEUTICAL USA, INC.]	1
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	PHOTO DYNAMIC THERAPY SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [G.S. COSMECEUTICAL USA, INC.]	1
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	PHOTO DYNAMIC THERAPY SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [G.S. COSMECEUTICAL USA, INC.]	1
AVOBENZONE	ACTIVE MOIETY	G63QQF2NOX	PHOTO DYNAMIC THERAPY SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [G.S. COSMECEUTICAL USA, INC.]	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	PHOTO DYNAMIC THERAPY SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [G.S. COSMECEUTICAL USA, INC.]	1
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	PHOTO DYNAMIC THERAPY SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [G.S. COSMECEUTICAL USA, INC.]	1
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	PHOTO DYNAMIC THERAPY SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [G.S. COSMECEUTICAL USA, INC.]	1
ALPHA-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	PHOTO DYNAMIC THERAPY SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [G.S. COSMECEUTICAL USA, INC.]	1
AMINO ACIDS	INACTIVE INGREDIENT	0O72R8RF8A	PHOTO DYNAMIC THERAPY SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [G.S. COSMECEUTICAL USA, INC.]	1
ANACYCLUS PYRETHRUM ROOT	INACTIVE INGREDIENT	X820IRW34J	PHOTO DYNAMIC THERAPY SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [G.S. COSMECEUTICAL USA, INC.]	1
ARNICA MONTANA FLOWER	INACTIVE INGREDIENT	OZ0E5Y15PZ	PHOTO DYNAMIC THERAPY SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [G.S. COSMECEUTICAL USA, INC.]	1
BUTYLOCTYL SALICYLATE	INACTIVE INGREDIENT	2EH13UN8D3	PHOTO DYNAMIC THERAPY SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [G.S. COSMECEUTICAL USA, INC.]	1
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	PHOTO DYNAMIC THERAPY SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [G.S. COSMECEUTICAL USA, INC.]	1
C12-15 ALKYL BENZOATE	INACTIVE INGREDIENT	A9EJ3J61HQ	PHOTO DYNAMIC THERAPY SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [G.S. COSMECEUTICAL USA, INC.]	1
CAMELLIA OLEIFERA LEAF	INACTIVE INGREDIENT	5077EL0C60	PHOTO DYNAMIC THERAPY SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [G.S. COSMECEUTICAL USA, INC.]	1
CUCUMBER	INACTIVE INGREDIENT	YY7C30VXJT	PHOTO DYNAMIC THERAPY SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [G.S. COSMECEUTICAL USA, INC.]	1
CYCLOMETHICONE 5	INACTIVE INGREDIENT	0THT5PCI0R	PHOTO DYNAMIC THERAPY SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [G.S. COSMECEUTICAL USA, INC.]	1
CYCLOMETHICONE 6	INACTIVE INGREDIENT	XHK3U310BA	PHOTO DYNAMIC THERAPY SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [G.S. COSMECEUTICAL USA, INC.]	1
DIAZOLIDINYL UREA	INACTIVE INGREDIENT	H5RIZ3MPW4	PHOTO DYNAMIC THERAPY SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [G.S. COSMECEUTICAL USA, INC.]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	PHOTO DYNAMIC THERAPY SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [G.S. COSMECEUTICAL USA, INC.]	1
ETHYLPARABEN	INACTIVE INGREDIENT	14255EXE39	PHOTO DYNAMIC THERAPY SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [G.S. COSMECEUTICAL USA, INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	PHOTO DYNAMIC THERAPY SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [G.S. COSMECEUTICAL USA, INC.]	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	PHOTO DYNAMIC THERAPY SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [G.S. COSMECEUTICAL USA, INC.]	1
GREEN TEA LEAF	INACTIVE INGREDIENT	W2ZU1RY8B0	PHOTO DYNAMIC THERAPY SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [G.S. COSMECEUTICAL USA, INC.]	1
HYALURONATE SODIUM	INACTIVE INGREDIENT	YSE9PPT4TH	PHOTO DYNAMIC THERAPY SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [G.S. COSMECEUTICAL USA, INC.]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	PHOTO DYNAMIC THERAPY SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [G.S. COSMECEUTICAL USA, INC.]	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	PHOTO DYNAMIC THERAPY SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [G.S. COSMECEUTICAL USA, INC.]	1
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	PHOTO DYNAMIC THERAPY SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [G.S. COSMECEUTICAL USA, INC.]	1
POMEGRANATE	INACTIVE INGREDIENT	56687D1Z4D	PHOTO DYNAMIC THERAPY SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [G.S. COSMECEUTICAL USA, INC.]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	PHOTO DYNAMIC THERAPY SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [G.S. COSMECEUTICAL USA, INC.]	1
SHIITAKE MUSHROOM	INACTIVE INGREDIENT	1A64QN2D2F	PHOTO DYNAMIC THERAPY SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [G.S. COSMECEUTICAL USA, INC.]	1
SODIUM ASCORBYL PHOSPHATE	INACTIVE INGREDIENT	836SJG51DR	PHOTO DYNAMIC THERAPY SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [G.S. COSMECEUTICAL USA, INC.]	1
SORBITAN MONOOLEATE	INACTIVE INGREDIENT	06XEA2VD56	PHOTO DYNAMIC THERAPY SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [G.S. COSMECEUTICAL USA, INC.]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	PHOTO DYNAMIC THERAPY SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [G.S. COSMECEUTICAL USA, INC.]	1
TRICALCIUM PHOSPHATE	INACTIVE INGREDIENT	K4C08XP666	PHOTO DYNAMIC THERAPY SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [G.S. COSMECEUTICAL USA, INC.]	1
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	PHOTO DYNAMIC THERAPY SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [G.S. COSMECEUTICAL USA, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	PHOTO DYNAMIC THERAPY SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [G.S. COSMECEUTICAL USA, INC.]	1
YEAST	INACTIVE INGREDIENT	3NY3SM6B8U	PHOTO DYNAMIC THERAPY SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [G.S. COSMECEUTICAL USA, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65113-2432	PHOTO DYNAMIC THERAPY SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [G.S. COSMECEUTICAL USA, INC.]	1	Legacy NDC, 1 package rows	20101207_84ee9356-bc6b-4f45-9e46-8cd262e55a3c.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
95OOS7VE0Y	OXYBENZONE	131-57-7	OXYBENZONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
65113-2432-1	65113243201	30 mL in 1 BOTTLE, PUMP	30 ml	Historical