Orange Gel

Product NDC: 80641-016
11-digit product format: 806410016
Labeler code: 80641
Product ID: 80641-016_b99c06a3-7b97-4257-bd0c-8a9f3f6297de
Type: HUMAN OTC DRUG
Nonproprietary name: Avobenzone Octisalate Octocrylene Homosalate
Dosage form: GEL
Route: TOPICAL
Labeler: Vacation Inc.
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-03-08
Substance: AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength: 2.9; 6.9; 4.9; 9.5 g/100g; g/100g; g/100g; g/100g
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Orange Gel
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AVOBENZONE	2.9 g/100g
HOMOSALATE	6.9 g/100g
OCTISALATE	4.9 g/100g
OCTOCRYLENE	9.5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
G63QQF2NOX	Internal UNII lookup
V06SV4M95S	Internal UNII lookup
4X49Y0596W	Internal UNII lookup
5A68WGF6WM	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
132896ef-d6c6-4ec7-e063-6294a90a103b	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
80641-016-02	Orange Gel	2 in 1 CARTON	GEL	2		4
80641-016-30	Orange Gel	88 g in 1 TUBE	GEL	88		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80641-016	ORANGE GEL (AVOBENZONE OCTISALATE OCTOCRYLENE HOMOSALATE) GEL [VACATION INC.]	3	Current NDC, 2 package rows	20250420_132896ef-d6c6-4ec7-e063-6294a90a103b.zip

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 20 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Kiss My Face Purely Mineral Face Factor 50 Sunscreen SPF 50	ZINC OXIDE	Windmill Health Products, LLC	9771aa6d-a797-42d5-919b-3bf67ef5e040	2026-06-15	Warnings	Exact identifier application number: M020
Cellular Swiss UV Protection Veil SPF30	OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE	La Prairie, Inc.	dd946a3b-74b9-4ebd-b82f-0350f8f72834	2026-06-15	Warnings	Exact identifier application number: M020
365 WHOLE FOODS MARKET SPORT MINERAL SPF 30	ZINC OXIDE	Whole Foods Market, Inc.	6caf656c-246f-469e-84f8-98f80b84c65e	2026-06-15	Warnings	Exact identifier application number: M020
EVIL GOODS TALLOW SUNSCREEN SPF50	ZINC OXIDE	Moes Group LLC	543058d4-f375-d702-e063-6394a90a2640	2026-06-14	Warnings	Exact identifier application number: M020
LASSO TALLOW SUNSCREEN SPF 50	ZINC OXIDE	Moes Group LLC	54312883-1d40-121e-e063-6294a90a247d	2026-06-14	Warnings	Exact identifier application number: M020
SFL SUNSCREEN - SOL DEFENSE SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Lifeline Medical, Inc	5438c185-31c9-c51e-e063-6394a90ae9ef	2026-06-14	Warnings	Exact identifier application number: M020
Sunbetter Daily Mineral Protection Broad Spectrum SPF 75 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	SKINBETTER SCIENCE LLC	54106748-9810-d3ff-e063-6394a90a5b7a	2026-06-12	Warnings	Exact identifier application number: M020
Sunbetter Daily Mineral Protection Broad Spectrum SPF 70 Sheer Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	SKINBETTER SCIENCE LLC	5410e0ed-aed5-3279-e063-6294a90a0c3e	2026-06-12	Warnings	Exact identifier application number: M020
Target Up and Up Ultra Light Dry-Touch SPF 70 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	TARGET CORPORATION	5411f284-f4ed-4e0e-e063-6294a90af1f6	2026-06-12	Warnings	Exact identifier application number: M020
Target Up and Up Oil Control SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	TARGET CORPORATION	54141120-7682-9c05-e063-6394a90a877e	2026-06-12	Warnings	Exact identifier application number: M020
Rejuvaskin Mineral Facial Sunscreen SPF 32 Sheer	REJUVASKIN MINERAL FACIAL SUNSCREEN SPF 32 SHEER	Atlantic Medical Products , LLC	1a2ab632-6443-1aa9-e063-6394a90a0c05	2026-06-11	Warnings	Exact identifier application number: M020
it cosmetics Your Skin But Better CC Plus Natural Matte Color Correcting Pore Refining Full Coverage Skin Balancing Serum Broad Spectrum SPF 40 Sunscreen	ENSULIZOLE, OCTISALATE AND TITANIUM DIOXIDE	IT COSMETICS, LLC	f2990320-b61d-40b8-ba79-18d6b37e7f52	2026-06-11	Warnings	Exact identifier application number: M020
Lancome Paris UV Expert Supra Screen Invisible Sunscreen Serum Broad Spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	6c1c9ae3-650f-4cf6-bf21-d3d5229ec2fa	2026-06-11	Warnings	Exact identifier application number: M020
Lancome Paris UV Expert Supra Screen Invisible Sunscreen Serum Broad Spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	SICOS ET CIE	3c196ac0-dc07-40ad-865c-8177c75c935a	2026-06-11	Warnings	Exact identifier application number: M020
BelleJoss BROAD SPECTRUM SPF 50	BROAD SPECTRUM SPF 50	Guangzhou Liyan Cosmetics Technology Co., Ltd.	53e1b5ba-45fc-e811-e063-6394a90a65ac	2026-06-10	Warnings	Exact identifier application number: M020
MilaMiAmor SPF50 Sunscreen Lotion50mL	OCTINOXATE 7.5%, ZINC OXIDE 5%	Foshan Sugar Max Cosmetics CO.,Ltd	5379c00f-8222-6d12-e063-6294a90a8fad	2026-06-10	Warnings	Exact identifier application number: M020
HEY HOTTIE Shimmer dry oil mist sunscreen spf30	OCTOCRYLENE,OCTINOXATE	Guangdong Aimu Biological Technology Co., Ltd	53f19c01-0011-bc70-e063-6294a90ab879	2026-06-10	Warnings	Exact identifier application number: M020
SUNPLUS Solar Sheer SPF 50	OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE	SUNPLUS SKIN CARE LLC	86bffd22-dded-404e-8d8e-4c54082ce50f	2026-06-09	Warnings	Exact identifier application number: M020
Acewink Sunscreen	SUNSCREEN SPRAY	Shenzhen Qiming Biotechnology Co., Ltd.	53d19fa8-6f0e-2c11-e063-6294a90abb03	2026-06-09	Warnings	Exact identifier application number: M020
RE-NUTRIV AGE REVERSAL VITAL RADIANCE SERUM FOUNDATION SPF 20	OCTINOXATE AND TITANIUM DIOXIDE	ESTEE LAUDER INC	53d76b02-442e-7a5d-e063-6394a90ae1b3	2026-06-09	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
80641-016-02	80641001602	2 TUBE in 1 CARTON (80641-016-02) / 88 g in 1 TUBE (80641-016-30)	2 tube	2025-04-18	No	No	Current
80641-016-30	80641001630	88 g in 1 TUBE (80641-016-30)	88 g	2024-03-08	No	No	Current