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 172 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
e l f Camo Semi Matte CC SPF 30 Light 210 N	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	2f151e6c-ab2d-40cb-a67c-e067147ed702	2025-10-31	Warnings	Exact identifier application number: M020
e l f Camo Semi Matte CC SPF 30 Light 280 N	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	6b0b9204-f205-415b-bd16-1970958b8be7	2025-10-31	Warnings	Exact identifier application number: M020
e l f Camo Semi Matte CC SPF 30 Light 240 W	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	8c12a34c-f648-4b55-8265-d430c72ae205	2025-10-31	Warnings	Exact identifier application number: M020
e l f Camo Semi Matte CC SPF 30 Light 250 W	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	0b1c20e6-9d98-4b69-8fe0-ac5e9f2b9b2c	2025-10-31	Warnings	Exact identifier application number: M020
e l f Camo Semi Matte CC SPF 30 Medium 370 N	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	b8d4862e-2671-4b85-8338-f935e0d0194f	2025-10-31	Warnings	Exact identifier application number: M020
e l f Camo Semi Matte CC SPF 30 Medium 310 C	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	8d53abee-73bc-4268-b08d-0c196ff4d852	2025-10-31	Warnings	Exact identifier application number: M020
e l f Camo Semi Matte CC SPF 30 Medium 375 N	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	1de296f5-276b-4e8f-8db2-78ea01965c4a	2025-10-31	Warnings	Exact identifier application number: M020
e l f Camo Semi Matte CC SPF 30 Rich 610 N	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	75543b93-8ed9-4c7b-9fcf-99745df5a194	2025-10-31	Warnings	Exact identifier application number: M020
e l f Camo Semi Matte CC SPF 30 Rich 620 W	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	798eecb3-ff6e-46d1-9053-b40e9cd02e5c	2025-10-31	Warnings	Exact identifier application number: M020
e l f Camo Semi Matte CC SPF 30 Rich 640 W	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	cbf949b3-e640-48eb-acf6-fccd6f258865	2025-10-31	Warnings	Exact identifier application number: M020
e l f Camo Semi Matte CC SPF 30 Rich 650 C	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	b8bfad36-54b7-42f3-bb5b-5eda1a10f021	2025-10-31	Warnings	Exact identifier application number: M020
e l f Camo Semi Matte CC SPF 30 Rich 660 N	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	853100ea-a9dc-43eb-9715-125b543d2be0	2025-10-31	Warnings	Exact identifier application number: M020
e l f Camo Semi Matte CC SPF 30 Tan 400 W	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	e4f2b579-4886-4e20-a527-c033e9d60bf5	2025-10-31	Warnings	Exact identifier application number: M020
e l f Camo Semi Matte CC SPF 30 Tan 460 W	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	49255019-fa24-4667-b527-ef7189a51f12	2025-10-31	Warnings	Exact identifier application number: M020
SEKKISEI HERBAL UV DEFENSE gel	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	KOS America, Inc.	cb0faa3a-68f8-49c5-8c28-3338b1b27cd8	2025-10-31	Warnings	Exact identifier application number: M020
Perricone MD Hypoallergenic Clean Correction Ultra-Lightweight Calming SPF 35 Veil	ZINC OXIDE	THG Beauty USA LLC	2c749a52-adaa-2609-e063-6294a90a8fc2	2025-10-30	Warnings	Exact identifier application number: M020
ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF45 BROAD SPECTRUM	AVOBENZONE, HOMOSALATE, OCTISALATE	SEORIN COMPANY Co., Ltd.	4260e410-d2d5-71b4-e063-6294a90a05b8	2025-10-30	Warnings	Exact identifier application number: M020
Clove Hill Tinted Mineral Sunscreen SPF 40	TITANIUM DIOXIDE, ZINC OXIDE	Clove Hill LLC	eb2ff5a7-384f-4379-b149-47c1c8c2291d	2025-10-30	Warnings	Exact identifier application number: M020
Tinted Mineral Lip Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Clove Hill LLC	a37db64d-8b79-40f4-843f-f38949c5b9d2	2025-10-30	Warnings	Exact identifier application number: M020
WEIGHTLESS PROTECTION SPF 30	OCTINOXATE, ZINC OXIDE, OCTISALATE	Botanical Science Technologies	de9a97b8-6633-4d71-e053-2995a90a5e8f	2025-10-30	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