MKRS

Product NDC: 13630-0091
11-digit product format: 136300091
Labeler code: 13630
Product ID: 13630-0091_e1f7b435-c0f8-2220-e053-2a95a90a9d47
Type: HUMAN OTC DRUG
Nonproprietary name: Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone
Dosage form: AEROSOL, SPRAY
Route: TOPICAL
Labeler: Prime Packaging, Inc.
Application: M020
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2015-08-01
Marketing end: 2022-06-30
Substance: AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Active strength: 29 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag: No
Listing certified through: 0000-00-00
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	13630-0091		D	Discontinued by firm		2026-10-27
excluded package	package	13630-0091	13630-0091-4	D	Discontinued by firm		2026-10-27

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 · 24 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	13630-0091-4	`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	13630-0091-4	`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	13630-0091-4	`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	13630-0091-4	`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	13630-0091-4	`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	13630-0091-4	`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	13630-0091-4	`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	13630-0091-4	`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	13630-0091-4	`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	13630-0091-4	`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	13630-0091-4	`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	13630-0091-4	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AVOBENZONE	ACTIVE INGREDIENT	G63QQF2NOX	MKRS BROAD SPECTRUM SPF50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) AEROSOL, SPRAY [PRIME PACKAGING, INC.]	1
HOMOSALATE	ACTIVE INGREDIENT	V06SV4M95S	MKRS BROAD SPECTRUM SPF50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) AEROSOL, SPRAY [PRIME PACKAGING, INC.]	1
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	MKRS BROAD SPECTRUM SPF50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) AEROSOL, SPRAY [PRIME PACKAGING, INC.]	1
OCTOCRYLENE	ACTIVE INGREDIENT	5A68WGF6WM	MKRS BROAD SPECTRUM SPF50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) AEROSOL, SPRAY [PRIME PACKAGING, INC.]	1
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	MKRS BROAD SPECTRUM SPF50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) AEROSOL, SPRAY [PRIME PACKAGING, INC.]	1
AVOBENZONE	ACTIVE MOIETY	G63QQF2NOX	MKRS BROAD SPECTRUM SPF50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) AEROSOL, SPRAY [PRIME PACKAGING, INC.]	1
HOMOSALATE	ACTIVE MOIETY	V06SV4M95S	MKRS BROAD SPECTRUM SPF50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) AEROSOL, SPRAY [PRIME PACKAGING, INC.]	1
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	MKRS BROAD SPECTRUM SPF50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) AEROSOL, SPRAY [PRIME PACKAGING, INC.]	1
OCTOCRYLENE	ACTIVE MOIETY	5A68WGF6WM	MKRS BROAD SPECTRUM SPF50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) AEROSOL, SPRAY [PRIME PACKAGING, INC.]	1
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	MKRS BROAD SPECTRUM SPF50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) AEROSOL, SPRAY [PRIME PACKAGING, INC.]	1
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	MKRS BROAD SPECTRUM SPF50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) AEROSOL, SPRAY [PRIME PACKAGING, INC.]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	MKRS BROAD SPECTRUM SPF50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) AEROSOL, SPRAY [PRIME PACKAGING, INC.]	1
BUTYL MALEURATE	INACTIVE INGREDIENT	6FUA0H660I	MKRS BROAD SPECTRUM SPF50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) AEROSOL, SPRAY [PRIME PACKAGING, INC.]	1
ISOBORNYL ACRYLATE	INACTIVE INGREDIENT	IX0PRH184P	MKRS BROAD SPECTRUM SPF50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) AEROSOL, SPRAY [PRIME PACKAGING, INC.]	1
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	MKRS BROAD SPECTRUM SPF50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) AEROSOL, SPRAY [PRIME PACKAGING, INC.]	1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 98 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Eucerin Face immersive Hydration	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Beiersdorf Inc	fe0b3717-f472-3a61-e053-6394a90a44fb	2025-12-31	Warnings	Exact identifier application number: M020
NIVEA MEN Age Defense Face Moisturizer	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Beiersdorf Inc	27cbec3e-e811-6498-e063-6394a90ada49	2025-12-31	Warnings	Exact identifier application number: M020
Nivea Men Maximum Hydration Face	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Beiersdorf Inc	f1276b11-6683-e982-e053-2a95a90a7803	2025-12-31	Warnings	Exact identifier application number: M020
Nivea Men Sensitive Protective	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Beiersdorf Inc	f6cff3d1-cca5-4b3e-a481-0c4def90684c	2025-12-31	Warnings	Exact identifier application number: M020
Nivea Smoothness Lip Care	AVOBENZONE,OCTOCRYLENE	Beiersdorf Inc	c28e327d-ad39-9bd6-e053-2a95a90a04eb	2025-12-31	Warnings	Exact identifier application number: M020
BOTANICAL SOOTHING SPF-30	OCTINOXATE, OCTISALATE, ZINC OXIDE	CONTROL CORRECTIVE SKINCARE INC	00a923fe-e6da-420e-a705-4773ecc2176b	2025-12-31	Warnings	Exact identifier application number: M020
AROMA MATTE DAY SUNSCREEN SPF-30	OCTINOXATE, OCTISALATE, ZINC OXIDE	CONTROL CORRECTIVE SKINCARE INC	f822f3ec-3c57-100a-e053-6294a90ab0ec	2025-12-31	Warnings	Exact identifier application number: M020
CONTROL CORRECTIVE TINTED MOISTURIZER SPF-30 SUNSCREEN	TITANIUM DIOXIDE, ZINC OXIDE	CONTROL CORRECTIVE SKINCARE INC	8ac09149-f7e7-40a8-b306-98964d0cd6e3	2025-12-31	Warnings	Exact identifier application number: M020
CONTROL CORRECTIVE SUNSCREEN SPF-30	OCTINOXATE, OCTISALATE, ZINC OXIDE	CONTROL CORRECTIVE SKINCARE INC	e389b2bc-bb1c-443a-9bf6-c6d96380f378	2025-12-31	Warnings	Exact identifier application number: M020
CONTROL CORRECTIVE INTENSIVE SKIN BRIGHTENING SPF-30 SUNSCREEN	OCTINOXATE, OCTISALATE, ZINC OXIDE	CONTROL CORRECTIVE SKINCARE INC	61b6dab9-3378-4206-bf1f-6f385a9c882c	2025-12-31	Warnings	Exact identifier application number: M020
Blue Lizard Sensitive SPF 50 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	Crown Laboratories	32d78048-d281-1d80-e063-6394a90aec19	2025-12-31	Warnings	Exact identifier application number: M020
DAYWEAR ANTI OXIDANT 72H-HYDRATION SORBET CREME BROAD SPECTRUM SPF 15	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	ESTEE LAUDER INC	df535004-c94c-4a28-ad20-78bd1741e39f	2025-12-31	Warnings	Exact identifier application number: M020
FUTURIST SKIN TINT SERUM	OCTINOXATE,OCTISALATE,ZINC OXIDE	ESTEE LAUDER INC	ea21e5a5-69d6-2de4-e053-2995a90a93b4	2025-12-31	Warnings	Exact identifier application number: M020
Dr.Jart Cicapair Tiger Grass Color Correcting Treatment	ZINC OXIDE, TITANIUM DIOXIDE	Have & Be Co., Ltd.	40f96baf-0359-4d68-801f-68562c909446	2025-12-31	Warnings	Exact identifier application number: M020
Dr.Jart Premium Beauty Balm Fair-Light	ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	Have & Be Co., Ltd.	b38b1b64-b433-4e11-9cf6-2108a552d139	2025-12-31	Warnings	Exact identifier application number: M020
Dr.Jart Premium Beauty Balm Light Medium-Medium	ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	Have & Be Co., Ltd.	45b1c2c6-a45b-4a45-bec9-e5341079c0a1	2025-12-31	Warnings	Exact identifier application number: M020
Dr.Jart Premium Beauty Balm Medium-Tan	ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	Have & Be Co., Ltd.	28a2ba45-1eff-488c-aae4-362b9f78b8df	2025-12-31	Warnings	Exact identifier application number: M020
Dr.Jart Premium Beauty Balm Deep Tan-Deep	ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	Have & Be Co., Ltd.	3c346960-b76b-4241-a188-8ee694853078	2025-12-31	Warnings	Exact identifier application number: M020
DR.JART CICAPAIR TIGER GRASS CAMO DROPS	ZINC OXIDE, TITANIUM DIOXIDE	Have & Be Co., Ltd.	f06348f5-4ebc-325b-e053-2a95a90ada52	2025-12-31	Warnings	Exact identifier application number: M020
DR.JART EVERY SUN DAY MINERAL SUN SCREEN	TITANIUM DIOXIDE, ZINC OXIDE	Have & Be Co., Ltd.	f06c31b4-da5f-6495-e053-2995a90ae67c	2025-12-31	Warnings	Exact identifier application number: M020

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
13630-0091-4	13630009104	177 mL in 1 CAN (13630-0091-4)	177 ml	2015-08-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MKRS Broad Spectrum SPF50 - Prime Packaging, Inc. \| Prime Enterprises, Inc.	Prime Packaging, Inc. \| Prime Enterprises, Inc.	2022-06-21	HUMAN OTC DRUG LABEL	4