mineral sunscreen spf-30

Generic: titanium dioxide, zinc oxide

Labeler: newco llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name mineral sunscreen spf-30
Generic Name titanium dioxide, zinc oxide
Labeler newco llc
Dosage Form LIQUID
Routes
TOPICAL
Active Ingredients

titanium dioxide 60 mg/mL, zinc oxide 60 mg/mL

Manufacturer
NEWCO LLC

Identifiers & Regulatory

Product NDC 83387-399
Product ID 83387-399_09769ae3-d1b1-e2dd-e063-6294a90a1f64
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M020
Listing Expiration 2026-12-31
Marketing Start 2023-04-17

Pharmacologic Class

Classes
copper absorption inhibitor [epc] decreased copper ion absorption [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83387399
Hyphenated Format 83387-399

Supplemental Identifiers

UPC
0615870636022
UNII
15FIX9V2JP SOI2LOH54Z

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 mineral sunscreen spf-30 (source: ndc)
Generic Name titanium dioxide, zinc oxide (source: ndc)
Application Number M020 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/mL
source: ndc
Packaging
  • 177 mL in 1 BOTTLE, SPRAY (83387-399-00)
source: ndc

Packages (1)

83387-399-00 177 mL in 1 BOTTLE, SPRAY (83387-399-00)

Ingredients (2)

titanium dioxide (60 mg/mL) zinc oxide (60 mg/mL)

Linked Drug Pages (1)

Mineral Sunscreen SPF-30 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "09769ae3-d1b1-e2dd-e063-6294a90a1f64", "openfda": {"upc": ["0615870636022"], "unii": ["15FIX9V2JP", "SOI2LOH54Z"], "spl_set_id": ["fa3c73a3-0dfb-4673-822a-45d946dee260"], "manufacturer_name": ["NEWCO LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "177 mL in 1 BOTTLE, SPRAY (83387-399-00)", "package_ndc": "83387-399-00", "marketing_start_date": "20230417"}], "brand_name": "Mineral Sunscreen SPF-30", "product_id": "83387-399_09769ae3-d1b1-e2dd-e063-6294a90a1f64", "dosage_form": "LIQUID", "pharm_class": ["Copper Absorption Inhibitor [EPC]", "Decreased Copper Ion Absorption [PE]"], "product_ndc": "83387-399", "generic_name": "TITANIUM DIOXIDE, ZINC OXIDE", "labeler_name": "NEWCO LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Mineral Sunscreen SPF-30", "active_ingredients": [{"name": "TITANIUM DIOXIDE", "strength": "60 mg/mL"}, {"name": "ZINC OXIDE", "strength": "60 mg/mL"}], "application_number": "M020", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20230417", "listing_expiration_date": "20261231"}