ultra violette supreme screen broad spectrum spf 50

Generic: avobenzone,homosalate,octisalate,octocrylene

Labeler: grace and fire usa inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name ultra violette supreme screen broad spectrum spf 50
Generic Name avobenzone,homosalate,octisalate,octocrylene
Labeler grace and fire usa inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

avobenzone 30 mg/mL, homosalate 70 mg/mL, octisalate 50 mg/mL, octocrylene 80 mg/mL

Manufacturer
Grace and Fire USA Inc.

Identifiers & Regulatory

Product NDC 84803-100
Product ID 84803-100_48c3f84b-f739-78b6-e063-6394a90abf6a
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M020
Listing Expiration 2027-12-31
Marketing Start 2024-12-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 84803100
Hyphenated Format 84803-100

Supplemental Identifiers

UPC
9355909005917
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 ultra violette supreme screen broad spectrum spf 50 (source: ndc)
Generic Name avobenzone,homosalate,octisalate,octocrylene (source: ndc)
Application Number M020 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/mL
  • 70 mg/mL
  • 50 mg/mL
  • 80 mg/mL
source: ndc
Packaging
  • 5 mL in 1 TUBE (84803-100-05)
  • 15 mL in 1 TUBE (84803-100-15)
  • 20 mL in 1 BOTTLE, PLASTIC (84803-100-20)
  • 20 mL in 1 BOTTLE, PUMP (84803-100-21)
  • 50 mL in 1 TUBE (84803-100-50)
source: ndc

Packages (5)

84803-100-05 5 mL in 1 TUBE (84803-100-05) 84803-100-15 15 mL in 1 TUBE (84803-100-15) 84803-100-20 20 mL in 1 BOTTLE, PLASTIC (84803-100-20) 84803-100-21 20 mL in 1 BOTTLE, PUMP (84803-100-21) 84803-100-50 50 mL in 1 TUBE (84803-100-50)

Ingredients (4)

avobenzone (30 mg/mL) homosalate (70 mg/mL) octisalate (50 mg/mL) octocrylene (80 mg/mL)

Linked Drug Pages (1)

Ultra Violette Supreme Screen Broad Spectrum SPF 50 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "48c3f84b-f739-78b6-e063-6394a90abf6a", "openfda": {"upc": ["9355909005917"], "unii": ["G63QQF2NOX", "V06SV4M95S", "4X49Y0596W", "5A68WGF6WM"], "spl_set_id": ["24389324-19db-7eb5-e063-6394a90ad7fb"], "manufacturer_name": ["Grace and Fire USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 mL in 1 TUBE (84803-100-05)", "package_ndc": "84803-100-05", "marketing_start_date": "20241201"}, {"sample": false, "description": "15 mL in 1 TUBE (84803-100-15)", "package_ndc": "84803-100-15", "marketing_start_date": "20241201"}, {"sample": false, "description": "20 mL in 1 BOTTLE, PLASTIC (84803-100-20)", "package_ndc": "84803-100-20", "marketing_start_date": "20251210"}, {"sample": false, "description": "20 mL in 1 BOTTLE, PUMP (84803-100-21)", "package_ndc": "84803-100-21", "marketing_start_date": "20260119"}, {"sample": false, "description": "50 mL in 1 TUBE (84803-100-50)", "package_ndc": "84803-100-50", "marketing_start_date": "20241201"}], "brand_name": "Ultra Violette Supreme Screen Broad Spectrum SPF 50", "product_id": "84803-100_48c3f84b-f739-78b6-e063-6394a90abf6a", "dosage_form": "CREAM", "product_ndc": "84803-100", "generic_name": "AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE", "labeler_name": "Grace and Fire USA Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Ultra Violette Supreme Screen Broad Spectrum SPF 50", "active_ingredients": [{"name": "AVOBENZONE", "strength": "30 mg/mL"}, {"name": "HOMOSALATE", "strength": "70 mg/mL"}, {"name": "OCTISALATE", "strength": "50 mg/mL"}, {"name": "OCTOCRYLENE", "strength": "80 mg/mL"}], "application_number": "M020", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20241201", "listing_expiration_date": "20271231"}