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		2026-11-13
excluded package	package	13630-0091	13630-0091-4	D	Discontinued by firm		2026-11-13

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 155 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HANCHOBIT Sunscreen	TITANIUM DIOXIDE	HANCHOYEANBIOTEC Co.,Ltd.	375b60f1-ad33-578a-e063-6294a90a1fc6	2025-11-27	Warnings	Exact identifier application number: M020
EcoZinc x DSO Welders 98 percent UVC Protection Sunscreen for Welding	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	386e35de-cd13-f430-e063-6394a90acc84	2025-11-27	Warnings	Exact identifier application number: M020
HANCHOBIT Matte Sun Stick	TITANIUM DIOXIDE	HANCHOYEANBIOTEC Co.,Ltd.	375bacf7-9372-bff7-e063-6294a90ae67c	2025-11-27	Warnings	Exact identifier application number: M020
EcoZinc Natural Mineral Sunscreen SPF50	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	386e23ec-7618-f42c-e063-6394a90a595d	2025-11-27	Warnings	Exact identifier application number: M020
KOVR Military grade sunscreen for Men	ZINC OXIDE	ACTIVE LIFE INC	c9fbbc6e-6284-4308-89a3-98300c3a0320	2025-11-26	Warnings	Exact identifier application number: M020
Alba Botanica Sensitive Mineral SPF 50	ZINC OXIDE	The Hain Celestial Group, Inc.	4484b16f-f29a-60cc-e063-6294a90a2b9d	2025-11-26	Warnings	Exact identifier application number: M020
Alba Botanica Sheer Mineral SPF50	ZINC OXIDE	The Hain Celestial Group, Inc.	0cf9c4b9-8e85-980c-e063-6394a90a9e7e	2025-11-26	Warnings	Exact identifier application number: M020
Alba Botanica Sensitive Mineral SPF 30	ZINC OXIDE	The Hain Celestial Group, Inc.	44867882-d9c1-7389-e063-6294a90a7f77	2025-11-26	Warnings	Exact identifier application number: M020
Alba Botanica Sheer Mineral SPF30	ZINC OXIDE	The Hain Celestial Group, Inc.	0cf9361f-f292-6429-e063-6294a90add0e	2025-11-26	Warnings	Exact identifier application number: M020
ZO Skin Health Gel Sunscreen Broad-Spectrum SPF 50	AVOBENZONE, OCTISALATE, OCTOCRYLENE	ZO Skin Health, Inc.	ec8386f2-9cb7-40f4-e053-2995a90ac2d8	2025-11-26	Warnings	Exact identifier application number: M020
WOODSLEEP Tallow Sunscreen	TITANIUM DIOXIDE	Shantou Woodsleep Biotechnology Co., Ltd.	330a9f2e-7ce1-f83f-e063-6394a90a184a	2025-11-26	Warnings	Exact identifier application number: M020
WOODSLEEP Tallow Sunscreen	TITANIUM DIOXIDE	Shantou Woodsleep Biotechnology Co., Ltd.	33cdde09-e7ee-e003-e063-6394a90a8762	2025-11-26	Warnings	Exact identifier application number: M020
Native Mineral Suncare Zinc Oxide Sunscreen Tropical Breeze Broad Spectrum SPF 30	ZINC OXIDE	The Procter & Gamble Manufacturing Company	44718c3c-b081-bcfb-e063-6394a90a3786	2025-11-25	Warnings	Exact identifier application number: M020
Native Mineral Suncare Zinc Oxide Sunscreen Unscented Broad Spectrum SPF 30	ZINC OXIDE	The Procter & Gamble Manufacturing Company	4472cc1e-6b34-388b-e063-6394a90ac7b6	2025-11-25	Warnings	Exact identifier application number: M020
Native Mineral Suncare Zinc Oxide Sunscreen Pear and Coconut Water Broad Spectrum SPF 30	ZINC OXIDE	The Procter & Gamble Manufacturing Company	4472ef69-8992-fcab-e063-6294a90a6b90	2025-11-25	Warnings	Exact identifier application number: M020
Native Mineral Suncare Zinc Oxide Sunscreen Vanilla Milk and Shea Broad Spectrum SPF 30	ZINC OXIDE	The Procter & Gamble Manufacturing Company	44732f89-8ac3-8c5d-e063-6394a90aba73	2025-11-25	Warnings	Exact identifier application number: M020
Native Mineral Suncare Zinc Oxide Sunscreen Unscented Broad Spectrum SPF 30	ZINC OXIDE	The Procter & Gamble Manufacturing Company	447347d6-b8a3-7338-e063-6294a90abbf9	2025-11-25	Warnings	Exact identifier application number: M020
Native Mineral Suncare Zinc Oxide Sunscreen Pear and Coconut Water Broad Spectrum SPF 30	ZINC OXIDE	The Procter & Gamble Manufacturing Company	4473c4cc-f8b5-4a92-e063-6394a90ae690	2025-11-25	Warnings	Exact identifier application number: M020
salmon colored sunscreen	SALMON COLORED SUNSCREEN	Guangzhou Fantesy Biotechnology Co.,Ltd	4477964b-28f3-a371-e063-6294a90a4230	2025-11-25	Warnings	Exact identifier application number: M020
Safe Sea SPF 50 Mineral	ZINC OXIDE	Nidaria Technology Ltd.	f6cf9454-552b-486e-a38b-ab3c183b24a1	2025-11-24	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