broad spectrum spf45

Generic: zinc oxide, octinoxate

Labeler: drmtlgy, llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name broad spectrum spf45
Generic Name zinc oxide, octinoxate
Labeler drmtlgy, llc
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

octinoxate 7.5 g/100mL, zinc oxide 12 g/100mL

Manufacturer
Drmtlgy, LLC

Identifiers & Regulatory

Product NDC 83286-014
Product ID 83286-014_2d1ff714-acb3-41ba-86ee-8049bc1dd226
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M020
Listing Expiration 2026-12-31
Marketing Start 2025-05-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83286014
Hyphenated Format 83286-014

Supplemental Identifiers

UNII
4Y5P7MUD51 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 broad spectrum spf45 (source: ndc)
Generic Name zinc oxide, octinoxate (source: ndc)
Application Number M020 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 7.5 g/100mL
  • 12 g/100mL
source: ndc
Packaging
  • 50 mL in 1 BOTTLE (83286-014-01)
source: ndc

Packages (1)

83286-014-01 50 mL in 1 BOTTLE (83286-014-01)

Ingredients (2)

octinoxate (7.5 g/100mL) zinc oxide (12 g/100mL)

Linked Drug Pages (1)

Broad Spectrum SPF45 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "2d1ff714-acb3-41ba-86ee-8049bc1dd226", "openfda": {"unii": ["4Y5P7MUD51", "SOI2LOH54Z"], "spl_set_id": ["0445ee5f-45a8-4fd5-ae4d-62f66e6f0be8"], "manufacturer_name": ["Drmtlgy, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 mL in 1 BOTTLE (83286-014-01)", "package_ndc": "83286-014-01", "marketing_start_date": "20250501"}], "brand_name": "Broad Spectrum SPF45", "product_id": "83286-014_2d1ff714-acb3-41ba-86ee-8049bc1dd226", "dosage_form": "GEL", "pharm_class": ["Copper Absorption Inhibitor [EPC]", "Decreased Copper Ion Absorption [PE]"], "product_ndc": "83286-014", "generic_name": "Zinc Oxide, Octinoxate", "labeler_name": "Drmtlgy, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Broad Spectrum SPF45", "active_ingredients": [{"name": "OCTINOXATE", "strength": "7.5 g/100mL"}, {"name": "ZINC OXIDE", "strength": "12 g/100mL"}], "application_number": "M020", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250501", "listing_expiration_date": "20261231"}