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 243 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
REVLON AGE DEFYING FIRMING LIFTING MAKEUP SPF 15	OCTINOXATE, TITANIUM DIOXIDE MAKE-UP	Revlon Consumer Products Corp	d9209277-469d-48f4-bf64-f39a70c19596	2024-12-31	Warnings	Exact identifier application number: M020
Almay Smart Shade Skintone Matching Makeup Light	TITANIUM DIOXIDE ZINC OXIDE	Almay, Inc.	2a987b85-efdb-eb95-e063-6394a90aef81	2024-12-31	Warnings	Exact identifier application number: M020
ALMAY SMART SHADE ANTI-AGING SKINTONE MATCHING MAKEUP SPF 20 Light	TITANIUM DIOXIDE, ZINC OXIDE	Almay, Inc.	2a984dd9-7293-77f0-e063-6294a90a8f1e	2024-12-31	Warnings	Exact identifier application number: M020
Vichy Laboratoires Capital Soleil 50 Daily AntiAging Face Sunscreen Broad Spectrum SPF 50 Water Resistant 80 Minutes	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	LOreal USA Products Inc	097fc15e-ea17-47b2-9581-19c5e11592f6	2024-12-30	Warnings	Exact identifier application number: M020
HERBAL UV DEFENSE SPF40	HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE	COSMAX USA, CORPORATION	2a76fd94-2f1f-e6d8-e063-6294a90a287c	2024-12-30	Warnings	Exact identifier application number: M020
Almay Healthy Biome Makeup	HOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Almay	ab20969a-8640-307d-e053-2a95a90a004d	2024-12-30	Warnings	Exact identifier application number: M020
EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WALNUT BROWN COLOR BROAD SPECTRUM SPF 60 PLUS	OCTOCRYLENE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ENSULIZOLE	Exelencia importers Corp.	2a845e4c-86e7-1799-e063-6294a90a9b2b	2024-12-30	Warnings	Exact identifier application number: M020
American Crew All In One Face Balm Broad Spectrum SPF 15	OCTISALATE,HOMOSALATE,AVOBENZONE,OCTOCRYLENE	Revlon Consumer Products Corp	012be422-1b4c-443c-9484-02efc744296d	2024-12-30	Warnings	Exact identifier application number: M020
Advanced Ceramide Lift and Firm Day Cream Broad Spectrum Sunscreen SPF 15	OCTISALATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATE	REVLON	2a857553-5ad0-a0e2-e063-6294a90af435	2024-12-30	Warnings	Exact identifier application number: M020
SkinCeuticals Sheer Physical UV Defense Broad Spectrum SPF 50 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	L'Oreal USA Products Inc	2035ab03-80b4-49f4-b379-eb8bc42c9cee	2024-12-30	Warnings	Exact identifier application number: M020
PRISMA PROTECT SPF30	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Dermalogica, LLC.	713bad2e-bf32-4cd5-9630-b8d88d437686	2024-12-30	Warnings	Exact identifier application number: M020
Protection 50 Sport	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Dermalogica, LLC.	e9ace96a-7717-4f5a-8e1b-1f56f7498599	2024-12-30	Warnings	Exact identifier application number: M020
SkinCeuticals Physical Matte UV Defense Broad Spectrum SPF 50 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	L'Oreal USA Products Inc	b137b3d0-212b-440a-b158-62ace4b4eff3	2024-12-30	Warnings	Exact identifier application number: M020
SkinCeuticals Physical UV Defense Broad Spectrum SPF 30 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	L'Oreal USA Products Inc	3a6db7d3-6c59-4633-a97e-1c03127246d3	2024-12-30	Warnings	Exact identifier application number: M020
Dermablend Professional Leg and Body Makeup Broad Spectrum SPF 25 Sunscreen	OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	df62e1c2-ce72-4ded-8985-156dce9ff41d	2024-12-28	Warnings	Exact identifier application number: M020
LOreal Paris Revitalift Derm Intensives Invisible UV Fluid Broad Spectrum SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	L'Oreal USA Products Inc	02dddfc5-61e6-433b-8d6d-a17bf3fc8ed6	2024-12-28	Warnings	Exact identifier application number: M020
Vichy Laboratoires Aqualia Thermal UV Defense Broad Spectrum SPF 30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	Cosmetique Active Production	229eef79-39ae-4395-8100-64d1ece960d2	2024-12-28	Warnings	Exact identifier application number: M020
COOLA Mineral Sun Silk Creme Sunscreen SPF 30	ZINC OXIDE	COOLA LLC	bb9dd9a9-ec01-4e94-9172-3a72e68a417a	2024-12-27	Warnings	Exact identifier application number: M020
Bare Republic Mineral SPF 50	ZINC OXIDE	COOLA LLC	6a0db9da-ee45-4ab7-80de-4bf189efe75f	2024-12-27	Warnings	Exact identifier application number: M020
COOLA CLASSIC BODY SUNSCREEN Guava Mango Broad Spectrum SPF 50	AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE	COOLA LLC	9a397a2c-4734-4dae-93dd-15c68e6c297d	2024-12-27	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