broad spectrum spf 50 babies mineral sunscreen

Generic: titanium dioxide, zinc oxide

Labeler: aruba aloe balm nv
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name broad spectrum spf 50 babies mineral sunscreen
Generic Name titanium dioxide, zinc oxide
Labeler aruba aloe balm nv
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

titanium dioxide 100 mg/mL, zinc oxide 80 mg/mL

Manufacturer
Aruba Aloe Balm NV

Identifiers & Regulatory

Product NDC 53675-191
Product ID 53675-191_09866e0b-7358-2316-e063-6294a90a5009
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M020
Listing Expiration 2026-12-31
Marketing Start 2020-06-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 53675191
Hyphenated Format 53675-191

Supplemental Identifiers

UPC
0082252071007
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 broad spectrum spf 50 babies mineral sunscreen (source: ndc)
Generic Name titanium dioxide, zinc oxide (source: ndc)
Application Number M020 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
  • 80 mg/mL
source: ndc
Packaging
  • 59 mL in 1 TUBE (53675-191-02)
source: ndc

Packages (1)

53675-191-02 59 mL in 1 TUBE (53675-191-02)

Ingredients (2)

titanium dioxide (100 mg/mL) zinc oxide (80 mg/mL)

Linked Drug Pages (1)

Broad Spectrum SPF 50 Babies Mineral Sunscreen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "09866e0b-7358-2316-e063-6294a90a5009", "openfda": {"upc": ["0082252071007"], "unii": ["15FIX9V2JP", "SOI2LOH54Z"], "spl_set_id": ["a705f810-80c8-4853-a312-727076c27788"], "manufacturer_name": ["Aruba Aloe Balm NV"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "59 mL in 1 TUBE (53675-191-02)", "package_ndc": "53675-191-02", "marketing_start_date": "20200615"}], "brand_name": "Broad Spectrum SPF 50 Babies Mineral Sunscreen", "product_id": "53675-191_09866e0b-7358-2316-e063-6294a90a5009", "dosage_form": "CREAM", "pharm_class": ["Copper Absorption Inhibitor [EPC]", "Decreased Copper Ion Absorption [PE]"], "product_ndc": "53675-191", "generic_name": "TITANIUM DIOXIDE, ZINC OXIDE", "labeler_name": "Aruba Aloe Balm NV", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Broad Spectrum SPF 50 Babies Mineral Sunscreen", "active_ingredients": [{"name": "TITANIUM DIOXIDE", "strength": "100 mg/mL"}, {"name": "ZINC OXIDE", "strength": "80 mg/mL"}], "application_number": "M020", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20200615", "listing_expiration_date": "20261231"}