orange gel

Generic: avobenzone octisalate octocrylene homosalate

Labeler: vacation inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name orange gel
Generic Name avobenzone octisalate octocrylene homosalate
Labeler vacation inc.
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

avobenzone 2.9 g/100g, homosalate 6.9 g/100g, octisalate 4.9 g/100g, octocrylene 9.5 g/100g

Manufacturer
Vacation Inc.

Identifiers & Regulatory

Product NDC 80641-016
Product ID 80641-016_b99c06a3-7b97-4257-bd0c-8a9f3f6297de
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M020
Listing Expiration 2027-12-31
Marketing Start 2024-03-08

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 80641016
Hyphenated Format 80641-016

Supplemental Identifiers

UNII
G63QQF2NOX V06SV4M95S 4X49Y0596W 5A68WGF6WM

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name orange gel (source: ndc)
Generic Name avobenzone octisalate octocrylene homosalate (source: ndc)
Application Number M020 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 2.9 g/100g
  • 6.9 g/100g
  • 4.9 g/100g
  • 9.5 g/100g
source: ndc
Packaging
  • 2 TUBE in 1 CARTON (80641-016-02) / 88 g in 1 TUBE (80641-016-30)
  • 88 g in 1 TUBE (80641-016-30)
source: ndc

Packages (2)

80641-016-02 2 TUBE in 1 CARTON (80641-016-02) / 88 g in 1 TUBE (80641-016-30) 80641-016-30 88 g in 1 TUBE (80641-016-30)

Ingredients (4)

avobenzone (2.9 g/100g) homosalate (6.9 g/100g) octisalate (4.9 g/100g) octocrylene (9.5 g/100g)

Linked Drug Pages (1)

Orange Gel ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "b99c06a3-7b97-4257-bd0c-8a9f3f6297de", "openfda": {"unii": ["G63QQF2NOX", "V06SV4M95S", "4X49Y0596W", "5A68WGF6WM"], "spl_set_id": ["132896ef-d6c6-4ec7-e063-6294a90a103b"], "manufacturer_name": ["Vacation Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 TUBE in 1 CARTON (80641-016-02)  / 88 g in 1 TUBE (80641-016-30)", "package_ndc": "80641-016-02", "marketing_start_date": "20250418"}, {"sample": false, "description": "88 g in 1 TUBE (80641-016-30)", "package_ndc": "80641-016-30", "marketing_start_date": "20240308"}], "brand_name": "Orange Gel", "product_id": "80641-016_b99c06a3-7b97-4257-bd0c-8a9f3f6297de", "dosage_form": "GEL", "product_ndc": "80641-016", "generic_name": "Avobenzone Octisalate Octocrylene Homosalate", "labeler_name": "Vacation Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Orange Gel", "active_ingredients": [{"name": "AVOBENZONE", "strength": "2.9 g/100g"}, {"name": "HOMOSALATE", "strength": "6.9 g/100g"}, {"name": "OCTISALATE", "strength": "4.9 g/100g"}, {"name": "OCTOCRYLENE", "strength": "9.5 g/100g"}], "application_number": "M020", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240308", "listing_expiration_date": "20271231"}