Western Family Broad Spectrum SunscreenSPF 50

Product NDC: 55312-006
11-digit product format: 553120006
Labeler code: 55312
Product ID: 55312-006_1f1f76f1-ff31-416b-9b27-86ea2ab8a56b
Type: HUMAN OTC DRUG
Nonproprietary name: AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE
Dosage form: LOTION
Route: TOPICAL
Labeler: WESTERN FAMILY FOODS, INC.
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2014-07-02
Marketing end: 0000-00-00
Substance: AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Active strength: 3 g/100g; g/100g; g/100g; g/100g; g/100g
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	55312-006		I	Inactivated by FDA	2026-10-05
excluded package	package	55312-006	55312-006-22	I	Inactivated by FDA	2026-10-05
excluded package	package	55312-006	55312-006-57	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 2 · 66 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	55312-006-22	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55312-006-57	`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	55312-006-22	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55312-006-57	`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	55312-006-22	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55312-006-57	`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	55312-006-22	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55312-006-57	`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	55312-006-22	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55312-006-57	`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	55312-006-22	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55312-006-57	`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	55312-006-22	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55312-006-57	`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	55312-006-22	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55312-006-57	`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	55312-006-22	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55312-006-57	`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	55312-006-22	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55312-006-57	`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	55312-006-22	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55312-006-57	`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	55312-006-22	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55312-006-57	`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	55312-006-22	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	55312-006-57	`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	55312-006-22	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	55312-006-57	`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	55312-006-22	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	55312-006-57	`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	55312-006-22	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	55312-006-57	`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	55312-006-22	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	55312-006-57	`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	55312-006-22	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	55312-006-57	`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	55312-006-22	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	55312-006-57	`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	55312-006-22	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	55312-006-57	`e2bbac7714bc…`	`27bdfed8d636…`

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
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55312-006-22	2020-01-31	C162847	48780-1	9d75b9d0-7360-f424-e053-dadaa90a57ce	Drug Facts
55312-006-57	2020-01-31	C162847	48780-1	9d75b9d0-7360-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55312-006-22	Western Family Broad Spectrum SunscreenSPF 50 SPF 50	85 g in 1 BOTTLE, PLASTIC	LOTION	85		2
55312-006-57	Western Family Broad Spectrum SunscreenSPF 50 SPF 50	295 g in 1 BOTTLE, PLASTIC	LOTION	295		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AVOBENZONE	ACTIVE INGREDIENT	G63QQF2NOX	WESTERN FAMILY BROAD SPECTRUM SUNSCREENSPF 50 SPF 50 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]	2
HOMOSALATE	ACTIVE INGREDIENT	V06SV4M95S	WESTERN FAMILY BROAD SPECTRUM SUNSCREENSPF 50 SPF 50 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]	2
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	WESTERN FAMILY BROAD SPECTRUM SUNSCREENSPF 50 SPF 50 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]	2
OCTOCRYLENE	ACTIVE INGREDIENT	5A68WGF6WM	WESTERN FAMILY BROAD SPECTRUM SUNSCREENSPF 50 SPF 50 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]	2
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	WESTERN FAMILY BROAD SPECTRUM SUNSCREENSPF 50 SPF 50 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]	2
AVOBENZONE	ACTIVE MOIETY	G63QQF2NOX	WESTERN FAMILY BROAD SPECTRUM SUNSCREENSPF 50 SPF 50 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]	2
HOMOSALATE	ACTIVE MOIETY	V06SV4M95S	WESTERN FAMILY BROAD SPECTRUM SUNSCREENSPF 50 SPF 50 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]	2
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	WESTERN FAMILY BROAD SPECTRUM SUNSCREENSPF 50 SPF 50 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]	2
OCTOCRYLENE	ACTIVE MOIETY	5A68WGF6WM	WESTERN FAMILY BROAD SPECTRUM SUNSCREENSPF 50 SPF 50 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]	2
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	WESTERN FAMILY BROAD SPECTRUM SUNSCREENSPF 50 SPF 50 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]	2
ALUMINUM STARCH OCTENYLSUCCINATE	INACTIVE INGREDIENT	I9PJ0O6294	WESTERN FAMILY BROAD SPECTRUM SUNSCREENSPF 50 SPF 50 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]	2
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	WESTERN FAMILY BROAD SPECTRUM SUNSCREENSPF 50 SPF 50 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]	2
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	WESTERN FAMILY BROAD SPECTRUM SUNSCREENSPF 50 SPF 50 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	WESTERN FAMILY BROAD SPECTRUM SUNSCREENSPF 50 SPF 50 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	WESTERN FAMILY BROAD SPECTRUM SUNSCREENSPF 50 SPF 50 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]	2
POLYGLYCERYL-3 DISTEARATE	INACTIVE INGREDIENT	ZI1LK470XV	WESTERN FAMILY BROAD SPECTRUM SUNSCREENSPF 50 SPF 50 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	WESTERN FAMILY BROAD SPECTRUM SUNSCREENSPF 50 SPF 50 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]	2
SORBITAN ISOSTEARATE	INACTIVE INGREDIENT	01S2G2C1E4	WESTERN FAMILY BROAD SPECTRUM SUNSCREENSPF 50 SPF 50 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	WESTERN FAMILY BROAD SPECTRUM SUNSCREENSPF 50 SPF 50 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	WESTERN FAMILY BROAD SPECTRUM SUNSCREENSPF 50 SPF 50 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]	2
TOCOPHEROL	INACTIVE INGREDIENT	R0ZB2556P8	WESTERN FAMILY BROAD SPECTRUM SUNSCREENSPF 50 SPF 50 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]	2
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	WESTERN FAMILY BROAD SPECTRUM SUNSCREENSPF 50 SPF 50 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	WESTERN FAMILY BROAD SPECTRUM SUNSCREENSPF 50 SPF 50 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55312-006	WESTERN FAMILY BROAD SPECTRUM SUNSCREENSPF 50 SPF 50 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]	2	Legacy NDC, 2 package rows	20140703_41fbb0bf-65ce-409f-9291-3095d28a28b1.zip

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
5A68WGF6WM	OCTOCRYLENE	6197-30-4	OCTOCRYLENE
95OOS7VE0Y	OXYBENZONE	131-57-7	OXYBENZONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
55312-006-22	55312000622	85 g in 1 BOTTLE, PLASTIC	85 g	Historical
55312-006-57	55312000657	295 g in 1 BOTTLE, PLASTIC	295 g	Historical