the tinted serum broad spectrum spf 50

Generic: zinc oxide

Labeler: rationale group pty ltd
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name the tinted serum broad spectrum spf 50
Generic Name zinc oxide
Labeler rationale group pty ltd
Dosage Form EMULSION
Routes
TOPICAL
Active Ingredients

zinc oxide 240 mg/mL

Manufacturer
Rationale Group Pty Ltd

Identifiers & Regulatory

Product NDC 83108-001
Product ID 83108-001_450e05a9-b559-c077-e063-6394a90a55ca
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M020
Marketing Start 2022-11-25
Marketing End 2026-09-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83108001
Hyphenated Format 83108-001

Supplemental Identifiers

UPC
9359782001608
UNII
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 the tinted serum broad spectrum spf 50 (source: ndc)
Generic Name zinc oxide (source: ndc)
Application Number M020 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 240 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 BOX (83108-001-00) / 30 mL in 1 BOTTLE, DROPPER
  • 3 mL in 1 BOTTLE, DROPPER (83108-001-03)
  • 5 mL in 1 BOTTLE, DROPPER (83108-001-05)
  • 3 mL in 1 BOTTLE (83108-001-13)
  • 5 mL in 1 BOTTLE (83108-001-15)
source: ndc

Packages (5)

83108-001-00 1 BOTTLE, DROPPER in 1 BOX (83108-001-00) / 30 mL in 1 BOTTLE, DROPPER 83108-001-03 3 mL in 1 BOTTLE, DROPPER (83108-001-03) 83108-001-05 5 mL in 1 BOTTLE, DROPPER (83108-001-05) 83108-001-13 3 mL in 1 BOTTLE (83108-001-13) 83108-001-15 5 mL in 1 BOTTLE (83108-001-15)

Ingredients (1)

zinc oxide (240 mg/mL)

Linked Drug Pages (1)

The Tinted Serum Broad Spectrum SPF 50 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "450e05a9-b559-c077-e063-6394a90a55ca", "openfda": {"upc": ["9359782001608"], "unii": ["SOI2LOH54Z"], "spl_set_id": ["f8ffcbc0-0dd3-4fce-b38b-37d38d631b61"], "manufacturer_name": ["Rationale Group Pty Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 BOX (83108-001-00)  / 30 mL in 1 BOTTLE, DROPPER", "package_ndc": "83108-001-00", "marketing_end_date": "20260901", "marketing_start_date": "20221125"}, {"sample": true, "description": "3 mL in 1 BOTTLE, DROPPER (83108-001-03)", "package_ndc": "83108-001-03", "marketing_end_date": "20260901", "marketing_start_date": "20221208"}, {"sample": true, "description": "5 mL in 1 BOTTLE, DROPPER (83108-001-05)", "package_ndc": "83108-001-05", "marketing_end_date": "20260901", "marketing_start_date": "20221208"}, {"sample": true, "description": "3 mL in 1 BOTTLE (83108-001-13)", "package_ndc": "83108-001-13", "marketing_end_date": "20260901", "marketing_start_date": "20221208"}, {"sample": true, "description": "5 mL in 1 BOTTLE (83108-001-15)", "package_ndc": "83108-001-15", "marketing_end_date": "20260901", "marketing_start_date": "20221208"}], "brand_name": "The Tinted Serum Broad Spectrum SPF 50", "product_id": "83108-001_450e05a9-b559-c077-e063-6394a90a55ca", "dosage_form": "EMULSION", "pharm_class": ["Copper Absorption Inhibitor [EPC]", "Decreased Copper Ion Absorption [PE]"], "product_ndc": "83108-001", "generic_name": "ZINC OXIDE", "labeler_name": "Rationale Group Pty Ltd", "product_type": "HUMAN OTC DRUG", "brand_name_base": "The Tinted Serum Broad Spectrum SPF 50", "active_ingredients": [{"name": "ZINC OXIDE", "strength": "240 mg/mL"}], "application_number": "M020", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_end_date": "20260901", "marketing_start_date": "20221125"}