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 128 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sun Elegant Mineral Sunscreen Tinted	TITANIUM DIOXIDE, ZINC OXIDE	SKIN BY NESRIN	3580ae10-1867-cb68-e063-6394a90a72df	2025-12-12		Exact identifier application number: M020
Simply Zinc Mineral Sunscreen Tinted	ZINC OXIDE	SKIN BY NESRIN	3580da4f-116d-8108-e063-6294a90a7bf4	2025-12-12		Exact identifier application number: M020
PROTECTOR SOLAR NON-TINTED SPF SUNSCREEN	TITANIUM DIOXIDE, ZINC OXIDE	The Beez Kneez Skin Care & Acne Clinic LLC	358195c0-6d28-1ffe-e063-6394a90a6027	2025-12-12		Exact identifier application number: M020
PROTECTOR SOLAR TINTED SPF SUNSCREEN	ZINC OXIDE	The Beez Kneez Skin Care & Acne Clinic LLC	3581d973-ac0b-7d2e-e063-6294a90ae2b3	2025-12-12		Exact identifier application number: M020
Matte Velvet Tint	TITANIUM DIOXIDE, ZINC OXIDE	Brent Loftis, D.O., Inc., A California Medical Corporation	3583f860-664b-2658-e063-6394a90a3857	2025-12-12		Exact identifier application number: M020
Satin Tint	ZINC OXIDE	Brent Loftis, D.O., Inc., A California Medical Corporation	35920108-7f8a-27d4-e063-6294a90a0ef6	2025-12-12		Exact identifier application number: M020
SPF Lip	TITANIUM DIOXIDE, ZINC OXIDE	Brent Loftis, D.O., Inc., A California Medical Corporation	359297cd-10e2-6ddd-e063-6394a90a4aa0	2025-12-12		Exact identifier application number: M020
Matte Velvet Tint	TITANIUM DIOXIDE, ZINC OXIDE	Brent Loftis, D.O., Inc., A California Medical Corporation	359641c5-0e19-f243-e063-6394a90aeebc	2025-12-12		Exact identifier application number: M020
Satin Tint	ZINC OXIDE	Brent Loftis, D.O., Inc., A California Medical Corporation	359684cf-ca11-f9af-e063-6394a90ac4c1	2025-12-12		Exact identifier application number: M020
TINTED MINERAL SUNSCREEN SPF 40	TITANIUM DIOXIDE, ZINC OXIDE	DERMATOLOGY ARTS	35814d5d-fd34-05b3-e063-6294a90aadd1	2025-12-12		Exact identifier application number: M020
JAYSUING Rice Probiotics Sunscreen	TITANIUM DIOXIDE	Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.	45cdc741-9ce0-fd6c-e063-6294a90adc0b	2025-12-12	Warnings	Exact identifier application number: M020
Tinted Lip Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	LA HAIR DESIGN	36eb4cd3-778c-362f-e063-6294a90a059c	2025-12-11		Exact identifier application number: M020
Matte Finish	TITANIUM DIOXIDE, ZINC OXIDE	CLEAN BEAUTY BY ANAK LLC	37630c6c-f768-7b3e-e063-6394a90af565	2025-12-11		Exact identifier application number: M020
Signature Tint SPF 40	ZINC OXIDE	ADVANCED AESTHETICS SKIN CARE STUDIO, INC	348f1bd3-1245-2d9a-e063-6394a90a4787	2025-12-11		Exact identifier application number: M020
Mineral Lip Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	ADVANCED AESTHETICS SKIN CARE STUDIO, INC	348fcc63-d8e3-90a1-e063-6294a90ade11	2025-12-11		Exact identifier application number: M020
Tinted Sunscreen	ZINC OXIDE	Scottsdale Skin Boutique and Dermatology Pllc	34a54441-c741-0c46-e063-6294a90a9be8	2025-12-11		Exact identifier application number: M020
Instant Glow	ZINC OXIDE	CLEAN BEAUTY BY ANAK LLC	37620171-140d-e096-e063-6294a90af93b	2025-12-11		Exact identifier application number: M020
Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Scottsdale Skin Boutique Aesthetics Pllc	34a49563-c74b-2fd1-e063-6394a90a6c56	2025-12-11		Exact identifier application number: M020
Tinted Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Scottsdale Skin Boutique and Dermatology Pllc	34a52011-b781-75cf-e063-6394a90ae0f4	2025-12-11		Exact identifier application number: M020
Tinted Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Scottsdale Skin Boutique and Dermatology Pllc	34a632f5-4458-e335-e063-6394a90a9bcb	2025-12-11		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