Sunscreen Broad Spectrum SPF 50

Product NDC: 68828-165
11-digit product format: 688280165
Labeler code: 68828
Product ID: 68828-165_a8b44f5e-bd67-80d3-e053-2995a90aa542
Type: HUMAN OTC DRUG
Nonproprietary name: Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone
Dosage form: CREAM
Route: TOPICAL
Labeler: JAFRA COSMETICS INTERNATIONAL
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2013-02-19
Marketing end: 0000-00-00
Substance: AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Active strength: 3 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag: No
Listing certified through: 2021-12-31
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	68828-165		I	Inactivated by FDA	2026-10-15
excluded package	package	68828-165	68828-165-02	I	Inactivated by FDA	2026-10-15
excluded package	package	68828-165	68828-165-04	I	Inactivated by FDA	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 · 57 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	68828-165-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68828-165-02	`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	68828-165-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68828-165-02	`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	68828-165-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68828-165-02	`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	68828-165-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68828-165-02	`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	68828-165-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68828-165-02	`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	68828-165-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68828-165-02	`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	68828-165-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68828-165-02	`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	68828-165-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68828-165-02	`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	68828-165-04	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68828-165-02	`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	68828-165-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68828-165-02	`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	68828-165-04	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68828-165-02	`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	68828-165-04	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68828-165-02	`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	68828-165-04	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68828-165-02	`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	68828-165-04	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68828-165-02	`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	68828-165-04	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68828-165-02	`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	68828-165-04	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	68828-165-02	`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	68828-165-04	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	68828-165-02	`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	68828-165-04	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	68828-165-02	`bd6a592717d7…`	`303034d00443…`
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	68828-165-02	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	68828-165-04	`9bebd1f3094a…`	`5416666fcb17…`

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
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
1681bc73-b05f-12c3-1075-382ae39f449c	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
68828-165-02	2022-01-28	Sunscreen SPF 50
68828-165-04	2022-01-28	Sunscreen SPF 50
68828-165-02	2020-06-22	Sunscreen SPF 50
68828-165-04	2020-06-22	Sunscreen SPF 50
68828-165-02	2020-01-31	Sunscreen SPF 50
68828-165-04	2020-01-31	Sunscreen SPF 50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68828-165-01	Sunscreen Broad Spectrum SPF 50Jafra	125 mL in 1 TUBE	CREAM	125	4
68828-165-02	Sunscreen Broad Spectrum SPF 50Jafra	1 in 1 CARTON	CREAM	1	4
68828-165-03	Sunscreen Broad Spectrum SPF 50Jafra	200 mL in 1 TUBE	CREAM	200	4
68828-165-04	Sunscreen Broad Spectrum SPF 50Jafra	1 in 1 CARTON	CREAM	1	4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AVOBENZONE	ACTIVE INGREDIENT	G63QQF2NOX	SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]	1
HOMOSALATE	ACTIVE INGREDIENT	V06SV4M95S	SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]	1
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]	1
OCTOCRYLENE	ACTIVE INGREDIENT	5A68WGF6WM	SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]	1
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]	1
AVOBENZONE	ACTIVE MOIETY	G63QQF2NOX	SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]	1
HOMOSALATE	ACTIVE MOIETY	V06SV4M95S	SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]	1
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]	1
OCTOCRYLENE	ACTIVE MOIETY	5A68WGF6WM	SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]	1
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]	1
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]	1
ALLANTOIN	INACTIVE INGREDIENT	344S277G0Z	SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]	1
ALUMINUM STARCH OCTENYLSUCCINATE	INACTIVE INGREDIENT	I9PJ0O6294	SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]	1
ARACHIDYL ALCOHOL	INACTIVE INGREDIENT	1QR1QRA9BU	SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]	1
ARACHIDYL GLUCOSIDE	INACTIVE INGREDIENT	6JVW35JOOJ	SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]	1
ARGININE	INACTIVE INGREDIENT	94ZLA3W45F	SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]	1
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)	INACTIVE INGREDIENT	59TL3WG5CO	SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]	1
CHLORPHENESIN	INACTIVE INGREDIENT	I670DAL4SZ	SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]	1
CYCLOMETHICONE 5	INACTIVE INGREDIENT	0THT5PCI0R	SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]	1
DOCOSANOL	INACTIVE INGREDIENT	9G1OE216XY	SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]	1
ETHYLHEXYLGLYCERIN	INACTIVE INGREDIENT	147D247K3P	SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]	1
LAUROYL LYSINE	INACTIVE INGREDIENT	113171Q70B	SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]	1
LEVOMENOL	INACTIVE INGREDIENT	24WE03BX2T	SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]	1
METHYLISOTHIAZOLINONE	INACTIVE INGREDIENT	229D0E1QFA	SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]	1
MICA	INACTIVE INGREDIENT	V8A1AW0880	SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]	1
PANTHENOL	INACTIVE INGREDIENT	WV9CM0O67Z	SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]	1
PEG-100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68828-165	SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]	4	Legacy NDC, 4 package rows	20200623_9bf66460-1835-4135-b4be-016ffdabe9a8.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	Marketing start	Marketing end	Sample	Exclude flag	Status
68828-165-01	68828016501	125 mL in 1 TUBE	125 ml					Historical
68828-165-02	68828016502	1 TUBE in 1 CARTON (68828-165-02) > 125 mL in 1 TUBE (68828-165-01)	1 tube	2013-02-19	0000-00-00	No	No	Current
68828-165-03	68828016503	200 mL in 1 TUBE	200 ml					Historical
68828-165-04	68828016504	1 TUBE in 1 CARTON (68828-165-04) > 200 mL in 1 TUBE (68828-165-03)	1 tube	2013-02-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sunscreen SPF 50	JAFRA COSMETICS INTERNATIONAL \| Jafra Manufacturing, S.A. de C.V.	2020-06-22	HUMAN OTC DRUG LABEL	4