dermatone mineral spf 30

Generic: zinc oxide 20%

Labeler: dermatone labs llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name dermatone mineral spf 30
Generic Name zinc oxide 20%
Labeler dermatone labs llc
Dosage Form LOTION
Routes
TOPICAL
Active Ingredients

zinc oxide 20 g/100mL

Manufacturer
Dermatone Labs LLC

Identifiers & Regulatory

Product NDC 54414-030
Product ID 54414-030_4b210203-6e23-22c6-e063-6394a90a88c9
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M020
Listing Expiration 2027-12-31
Marketing Start 2025-08-21

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 54414030
Hyphenated Format 54414-030

Supplemental Identifiers

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 dermatone mineral spf 30 (source: ndc)
Generic Name zinc oxide 20% (source: ndc)
Application Number M020 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 20 g/100mL
source: ndc
Packaging
  • 89 mL in 1 CONTAINER (54414-030-02)
  • 59 mL in 1 CONTAINER (54414-030-03)
source: ndc

Packages (2)

54414-030-02 89 mL in 1 CONTAINER (54414-030-02) 54414-030-03 59 mL in 1 CONTAINER (54414-030-03)

Ingredients (1)

zinc oxide (20 g/100mL)

Linked Drug Pages (1)

Dermatone Mineral SPF 30 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "4b210203-6e23-22c6-e063-6394a90a88c9", "openfda": {"unii": ["SOI2LOH54Z"], "spl_set_id": ["26e3209f-cb5c-484e-9b2e-74dc397d4790"], "manufacturer_name": ["Dermatone Labs LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "89 mL in 1 CONTAINER (54414-030-02)", "package_ndc": "54414-030-02", "marketing_start_date": "20250821"}, {"sample": false, "description": "59 mL in 1 CONTAINER (54414-030-03)", "package_ndc": "54414-030-03", "marketing_start_date": "20250821"}], "brand_name": "Dermatone Mineral SPF 30", "product_id": "54414-030_4b210203-6e23-22c6-e063-6394a90a88c9", "dosage_form": "LOTION", "pharm_class": ["Copper Absorption Inhibitor [EPC]", "Decreased Copper Ion Absorption [PE]"], "product_ndc": "54414-030", "generic_name": "Zinc Oxide 20%", "labeler_name": "Dermatone Labs LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Dermatone Mineral SPF 30", "active_ingredients": [{"name": "ZINC OXIDE", "strength": "20 g/100mL"}], "application_number": "M020", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250821", "listing_expiration_date": "20271231"}