Skin Care Prescription

Product NDC: 52347-111
11-digit product format: 523470111
Labeler code: 52347
Product ID: 52347-111_4d08bcae-5846-41a6-8136-651da8e1c582
Type: HUMAN OTC DRUG
Nonproprietary name: Avobenzone,Octocrylene,Oxybenzone,Homosalate,Octisalate
Dosage form: LOTION
Route: TOPICAL
Labeler: Skin Care Physicians, Inc.
Application: part352
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2010-06-23
Marketing end: 0000-00-00
Substance: AVOBENZONE; HOMOSALATE; OXYBENZONE; OCTISALATE; OCTOCRYLENE
Active strength: 3 g/114.4g; g/113.4g; g/113.4g; g/113.4g; g/113.4g
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	52347-111		I	Inactivated by FDA		2026-10-20
excluded package	package	52347-111	52347-111-01	I	Inactivated by FDA		2026-10-20

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	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52347-111-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52347-111-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52347-111-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52347-111-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52347-111-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52347-111-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52347-111-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52347-111-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52347-111-01	`0efc9e666f02…`	`f202fb6c5f17…`
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	52347-111-01	`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	52347-111-01	`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	52347-111-01	`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	52347-111-01	`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	52347-111-01	`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	52347-111-01	`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	52347-111-01	`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	52347-111-01	`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	52347-111-01	`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	52347-111-01	`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	52347-111-01	`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	52347-111-01	`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	52347-111-01	`110d247fa046…`	`a55b01930146…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52347-111-01	2019-10-29	C162847	48780-1	960f7f55-c1ca-8e05-e053-dbdaa90a074a	Drug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Avobenzone	ACTIVE INGREDIENT	G63QQF2NOX	SKIN CARE PRESCRIPTION (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKIN CARE PHYSICIANS, INC.]	2
Homosalate	ACTIVE INGREDIENT	V06SV4M95S	SKIN CARE PRESCRIPTION (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKIN CARE PHYSICIANS, INC.]	2
Octisalate	ACTIVE INGREDIENT	4X49Y0596W	SKIN CARE PRESCRIPTION (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKIN CARE PHYSICIANS, INC.]	2
Octocrylene	ACTIVE INGREDIENT	5A68WGF6WM	SKIN CARE PRESCRIPTION (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKIN CARE PHYSICIANS, INC.]	2
Oxybenzone	ACTIVE INGREDIENT	95OOS7VE0Y	SKIN CARE PRESCRIPTION (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKIN CARE PHYSICIANS, INC.]	2
Avobenzone	ACTIVE MOIETY	G63QQF2NOX	SKIN CARE PRESCRIPTION (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKIN CARE PHYSICIANS, INC.]	2
Homosalate	ACTIVE MOIETY	V06SV4M95S	SKIN CARE PRESCRIPTION (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKIN CARE PHYSICIANS, INC.]	2
Octisalate	ACTIVE MOIETY	4X49Y0596W	SKIN CARE PRESCRIPTION (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKIN CARE PHYSICIANS, INC.]	2
Octocrylene	ACTIVE MOIETY	5A68WGF6WM	SKIN CARE PRESCRIPTION (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKIN CARE PHYSICIANS, INC.]	2
Oxybenzone	ACTIVE MOIETY	95OOS7VE0Y	SKIN CARE PRESCRIPTION (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKIN CARE PHYSICIANS, INC.]	2
ACAI	INACTIVE INGREDIENT	46AM2VJ0AW	SKIN CARE PRESCRIPTION (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKIN CARE PHYSICIANS, INC.]	2
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	SKIN CARE PRESCRIPTION (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKIN CARE PHYSICIANS, INC.]	2
ALPHA-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	SKIN CARE PRESCRIPTION (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKIN CARE PHYSICIANS, INC.]	2
ARNICA MONTANA	INACTIVE INGREDIENT	O80TY208ZW	SKIN CARE PRESCRIPTION (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKIN CARE PHYSICIANS, INC.]	2
Ascorbyl Palmitate	INACTIVE INGREDIENT	QN83US2B0N	SKIN CARE PRESCRIPTION (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKIN CARE PHYSICIANS, INC.]	2
C12-15 ALKYL BENZOATE	INACTIVE INGREDIENT	A9EJ3J61HQ	SKIN CARE PRESCRIPTION (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKIN CARE PHYSICIANS, INC.]	2
CARBOMER COPOLYMER TYPE A	INACTIVE INGREDIENT	71DD5V995L	SKIN CARE PRESCRIPTION (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKIN CARE PHYSICIANS, INC.]	2
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	SKIN CARE PRESCRIPTION (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKIN CARE PHYSICIANS, INC.]	2
CRANBERRY	INACTIVE INGREDIENT	0MVO31Q3QS	SKIN CARE PRESCRIPTION (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKIN CARE PHYSICIANS, INC.]	2
CUCUMBER	INACTIVE INGREDIENT	YY7C30VXJT	SKIN CARE PRESCRIPTION (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKIN CARE PHYSICIANS, INC.]	2
Dimethicone	INACTIVE INGREDIENT	92RU3N3Y1O	SKIN CARE PRESCRIPTION (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKIN CARE PHYSICIANS, INC.]	2
DMDM HYDANTOIN	INACTIVE INGREDIENT	BYR0546TOW	SKIN CARE PRESCRIPTION (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKIN CARE PHYSICIANS, INC.]	2
EDETIC ACID	INACTIVE INGREDIENT	9G34HU7RV0	SKIN CARE PRESCRIPTION (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKIN CARE PHYSICIANS, INC.]	2
ETHYLHEXYLGLYCERIN	INACTIVE INGREDIENT	147D247K3P	SKIN CARE PRESCRIPTION (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKIN CARE PHYSICIANS, INC.]	2
GLYCERYL DISTEARATE	INACTIVE INGREDIENT	73071MW2KM	SKIN CARE PRESCRIPTION (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKIN CARE PHYSICIANS, INC.]	2
Isopropyl Palmitate	INACTIVE INGREDIENT	8CRQ2TH63M	SKIN CARE PRESCRIPTION (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKIN CARE PHYSICIANS, INC.]	2
METHACRYLIC ACID	INACTIVE INGREDIENT	1CS02G8656	SKIN CARE PRESCRIPTION (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKIN CARE PHYSICIANS, INC.]	2
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	SKIN CARE PRESCRIPTION (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKIN CARE PHYSICIANS, INC.]	2
POLYOXYL 100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	SKIN CARE PRESCRIPTION (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKIN CARE PHYSICIANS, INC.]	2
PUNICA GRANATUM ROOT BARK	INACTIVE INGREDIENT	CLV24I3T1D	SKIN CARE PRESCRIPTION (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKIN CARE PHYSICIANS, INC.]	2
SAMBUCUS NIGRA FLOWER	INACTIVE INGREDIENT	07V4DX094T	SKIN CARE PRESCRIPTION (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKIN CARE PHYSICIANS, INC.]	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	SKIN CARE PRESCRIPTION (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKIN CARE PHYSICIANS, INC.]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	SKIN CARE PRESCRIPTION (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKIN CARE PHYSICIANS, INC.]	2
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	SKIN CARE PRESCRIPTION (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKIN CARE PHYSICIANS, INC.]	2
VITAMIN A PALMITATE	INACTIVE INGREDIENT	1D1K0N0VVC	SKIN CARE PRESCRIPTION (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKIN CARE PHYSICIANS, INC.]	2
Water	INACTIVE INGREDIENT	059QF0KO0R	SKIN CARE PRESCRIPTION (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKIN CARE PHYSICIANS, INC.]	2

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
95OOS7VE0Y	OXYBENZONE	131-57-7	OXYBENZONE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
5A68WGF6WM	OCTOCRYLENE	6197-30-4	OCTOCRYLENE