spf 40 broad spectrum

Generic: titanium dioxide, zinc oxide

Labeler: teton dermatology holdings, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name spf 40 broad spectrum
Generic Name titanium dioxide, zinc oxide
Labeler teton dermatology holdings, inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

titanium dioxide 80 mg/g, zinc oxide 38 mg/g

Manufacturer
Teton Dermatology Holdings, Inc.

Identifiers & Regulatory

Product NDC 85339-203
Product ID 85339-203_45b3a342-878a-6db5-e063-6294a90aa648
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M020
Listing Expiration 2026-12-31
Marketing Start 2023-10-27

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 85339203
Hyphenated Format 85339-203

Supplemental Identifiers

UPC
0385339203507
UNII
15FIX9V2JP SOI2LOH54Z

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 spf 40 broad spectrum (source: ndc)
Generic Name titanium dioxide, zinc oxide (source: ndc)
Application Number M020 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/g
  • 38 mg/g
source: ndc
Packaging
  • 53 g in 1 BOTTLE, PUMP (85339-203-50)
source: ndc

Packages (1)

85339-203-50 53 g in 1 BOTTLE, PUMP (85339-203-50)

Ingredients (2)

titanium dioxide (80 mg/g) zinc oxide (38 mg/g)

Linked Drug Pages (1)

SPF 40 Broad Spectrum ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "45b3a342-878a-6db5-e063-6294a90aa648", "openfda": {"upc": ["0385339203507"], "unii": ["15FIX9V2JP", "SOI2LOH54Z"], "spl_set_id": ["35081ce0-2203-ab86-e063-6294a90aefd5"], "manufacturer_name": ["Teton Dermatology Holdings, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "53 g in 1 BOTTLE, PUMP (85339-203-50)", "package_ndc": "85339-203-50", "marketing_start_date": "20231027"}], "brand_name": "SPF 40 Broad Spectrum", "product_id": "85339-203_45b3a342-878a-6db5-e063-6294a90aa648", "dosage_form": "CREAM", "product_ndc": "85339-203", "generic_name": "Titanium Dioxide, Zinc Oxide", "labeler_name": "Teton Dermatology Holdings, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "SPF 40 Broad Spectrum", "active_ingredients": [{"name": "TITANIUM DIOXIDE", "strength": "80 mg/g"}, {"name": "ZINC OXIDE", "strength": "38 mg/g"}], "application_number": "M020", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20231027", "listing_expiration_date": "20261231"}