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 181 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Petroleum-Free Lip Balm	OCTINOXATE AND OXYBENZONE	Medline Industries, LP	6125d98a-6fc7-4f50-924e-3b1f7ee951f4	2025-10-09	Warnings	Exact identifier application number: M020
Daybird Tinted Skincare (SHADE 1)	ZINC OXIDE	Resette, Inc	dc89429a-022c-dd10-e053-2a95a90ac26a	2025-10-09	Warnings	Exact identifier application number: M020
Daybird Tinted Skincare (SHADE 2)	ZINC OXIDE	Resette, Inc	dc89ab76-da2f-4f6f-e053-2995a90a8bcb	2025-10-09	Warnings	Exact identifier application number: M020
Dr Lift SPF 50 Clear Stick	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Spa de Soleil	40c11b19-fc91-2033-e063-6394a90a5a5f	2025-10-09	Warnings	Exact identifier application number: M020
Black Girl Sunscreen Make It Mineral Baby	ZINC OXIDE	Black Girl Sunscreen	302bccc6-7bf3-cc69-e063-6294a90a625c	2025-10-09	Warnings	Exact identifier application number: M020
Babo Botanicals Sheer Zinc Mineral Sunscreen SPF30	ZINC OXIDE	Babo Botanicals, Inc.	08f0436b-85b6-5099-e063-6294a90a4c2e	2025-10-09	Warnings	Exact identifier application number: M020
CoreTex Professional Outdoor Skin Protection Wallet	CORETEX PROFESSIONAL OUTDOOR SKIN PROTECTION WALLET	CoreTex Products Inc	f57bc089-405b-cdcd-e053-2995a90a9d12	2025-10-09	Warnings	Exact identifier application number: M020
Mist Me SPF-40	ZINC OXIDE	Cove Suncare LLC	b7f09089-54a4-4f60-b632-e3f4321313ec	2025-10-09	Warnings	Exact identifier application number: M020
Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	Allergan, Inc.	29817fdc-f14c-4013-a8ed-4367f3b2867c	2025-10-09	Warnings	Exact identifier application number: M020
Skinny Dip SPF-50	ZINC OXIDE	Cove Suncare LLC	7bef2966-9351-4ea6-aeed-0d568376d86b	2025-10-08	Warnings	Exact identifier application number: M020
Neutrogena Invisible Daily Defense Broad Spectrum SPF 60 Plus	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	0f0ba2e9-126f-13c0-e063-6394a90aa6a4	2025-10-08	Warnings	Exact identifier application number: M020
Neutrogena Invisible Daily Defense Face Serum Sunscreen Broad Spectrum SPF 60	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	08997bd4-d6b9-fffc-e063-6294a90a77ae	2025-10-08	Warnings	Exact identifier application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF70	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE	Kenvue Brands LLC	75f81b2d-cabc-443f-b4b5-76bd2321826b	2025-10-08	Warnings	Exact identifier application number: M020
Neutrogena Invisible Daily Defense Sunscreen Broad Spectrum SPF 60 Plus	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	1390f863-709e-412b-9a25-b65217844e44	2025-10-08	Warnings	Exact identifier application number: M020
Neutrogena Invisible Daily Defense Sunscreen Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	ccc2e40b-5301-4055-8a89-47366687cfb7	2025-10-08	Warnings	Exact identifier application number: M020
Neutrogena Invisible Daily Defense Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	0f0dd2e4-3dda-c872-e063-6294a90a20a3	2025-10-08	Warnings	Exact identifier application number: M020
ScalpHair MistSunscreen SPF30	COOLA SCALPHAIR MIST ORGANIC SUNSCREEN SPF30	COOLA LLC	c7d2098f-6fdf-68e5-e053-2a95a90a1898	2025-10-08	Warnings	Exact identifier application number: M020
Block Party SPF-50	ZINC OXIDE	Cove Suncare LLC	24ffb6ec-d922-40c0-b325-c15f8433027a	2025-10-08	Warnings	Exact identifier application number: M020
Sun Kids mineral BLUEBERRY SUNSCREEN BROAD SPECTRUM SPF 50	ZINC OXIDE	The Natural SKN Company	40945805-6f2e-74a1-e063-6394a90a04a3	2025-10-07	Warnings	Exact identifier application number: M020
ProtecTINT 10N	HOMOSALATE, OCTISALATE, ZINC OXIDE	Supergoop, LLC	0801287f-0df5-4303-e063-6394a90a503b	2025-10-07	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