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		2026-10-23
excluded package	package	13630-0091	13630-0091-4	D	Discontinued by firm		2026-10-23

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 48 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Avebonzone, Homosalate, Octisalate	AVEBONZONE, HOMOSALATE, OCTISALATE	Amazon.com Services LLC	4ab6773f-00e1-897a-e063-6294a90ab0b8	2026-04-06	Warnings, Adverse reactions	Exact identifier application number: M020
Principal Secret Revolutionary Anti-Aging Broad Spectrum SPF 15	AVOBENZONE, OCTINOXATE, OCTISALATE, AND OCTOCRYLENE	Guthy-Renker LLC	eb1a9b67-b9e2-41f8-bc6d-df94b6a33ab8	2026-04-06	Warnings	Exact identifier application number: M020
TIRTIR HYDRO UV SHIELD SUNSCREEN SPF50 BROAD SPECTRUM	HOMOSALATE, AVOBENZONE, OCTISALATE, OCTOCRYLENE	TIRTIR USA Inc.	4ec04105-e54f-a82e-e063-6394a90a6c5a	2026-04-05	Warnings	Exact identifier application number: M020
PRVWORA Ultra Defense Sunscreen	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Cellarkbio Inc.	50cf1d88-3e7e-47b7-816a-3d579bde0a6a	2026-04-04	Warnings	Exact identifier application number: M020
EltaMD UV Shield SPF45	ZINC OXIDE AND OCTINOXATE SUNSCREEN	CP Skin Health Group, Inc.	7c49f971-d425-4be9-a665-5cd218b7f945	2026-04-03	Warnings	Exact identifier application number: M020
Jack Black	AVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUM	Jack Black L.L.C.	4baade5c-e759-d98f-e063-6394a90aa056	2026-04-03	Warnings	Exact identifier application number: M020
Vacation SPF 30 ClassicSpray	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Vacation Inc.	da43d71d-733b-5700-e053-2a95a90a5dca	2026-04-03	Warnings	Exact identifier application number: M020
Warriors Crown Sentinel Zinc Defense Sunscreen SPF 30	ZINC OXIDE	Allure Labs	4e93e64a-97ab-e0a5-e063-6294a90ad950	2026-04-03	Warnings	Exact identifier application number: M020
Pro-Collagen Marine Broad Spectrum SPF 30	AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE	ELEMIS Limited	3321281e-612b-4305-bf6d-bfab02c65ffb	2026-04-03	Warnings	Exact identifier application number: M020
EltaMD Skincare UV AOX Elements SPF50 Tinted	TITANIUM DIOXIDE, ZINC OXIDE SUNSCREEN	CP Skin Health Group, Inc	2c74209d-9b88-4c32-ad42-cd6de16c1fef	2026-04-03	Warnings	Exact identifier application number: M020
EltaMD UV Restore Tinted	TITANIUM DIOXIDE AND ZINC OXIDE SUNSCREEN	CP Skin Health Group, Inc	4fc18856-01b3-43ed-9e1b-b4394e31aa3c	2026-04-03	Warnings	Exact identifier application number: M020
Sunscreen for baby SPF50plus	OCTOCRYLENE,ETHYLHEXYL METHOXYCINNAMATE,TITANIUM DIOXIDE,ETHYLHEXYL SALICYLATE	Guangzhou Senmai Biotechnology Co., Ltd.	1cb7fbca-0874-ae53-e063-6294a90ab42a	2026-04-02	Warnings	Exact identifier application number: M020
TiZO3	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, LTD	4e7bdec2-abcc-0267-e063-6394a90ae47a	2026-04-02	Warnings	Exact identifier application number: M020
TIZO PHOTOCEUTICAL AM REPLENISH - TINTED	ZINC OXIDE	Fallien Cosmeceuticals, LTD	4e7c4702-5707-6c3e-e063-6394a90a05fd	2026-04-02	Warnings	Exact identifier application number: M020
Ilia Sun Serum Mineral Sunscreen SPF 50 Light Medium	ZINC OXIDE	Ilia, Inc.	4e7cc73c-d6c9-ecb0-e063-6394a90a922c	2026-04-02	Warnings	Exact identifier application number: M020
EltaMD UV Restore	TITANIUM DIOXIDE, ZINC OXIDE SUNSCREEN	CP Skin Health Group, Inc	17b47994-82d6-4f9d-8249-bdb55106c9b3	2026-04-02	Warnings	Exact identifier application number: M020
Hand Sunscreen Cream	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Jiangsu Senwo Medical Technology Co., Ltd.	4e615757-76b1-8f34-e063-6394a90a280a	2026-04-01	Warnings	Exact identifier application number: M020
All Good Mineral Sport Sunscreen Sunstick SPF 30	ZINC OXIDE	Elemental Herbs, Inc.	4e67b76e-b791-4e26-e063-6294a90aa991	2026-04-01	Warnings	Exact identifier application number: M020
All Good Coconut Mineral Sunscreen Sunstick SPF 30	ZINC OXIDE	Elemental Herbs, Inc.	4e67e89b-a7be-a540-e063-6294a90a6d8f	2026-04-01	Warnings	Exact identifier application number: M020
SHISEIDO BENEFIANCE WRINKLE SMOOTHING DAY	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Shiseido Americas Corporation	cad3a446-36a8-4146-81b5-1cc8d65abf14	2026-04-01	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