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United States· US:53675-191_09866e0b-7358-2316-e063-6294a90a5009

Broad Spectrum SPF 50 Babies Mineral Sunscreen

A medicinal product containing titanium dioxide, zinc oxide, registered in United States by Aruba Aloe Balm NV.

US label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedBroad Spectrum SPF 50 Babies Mineral …ATC—REGISTER NO.US:53675-191_09866e0b…PACKS LISTED1CHECKEDJune 3, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
TITANIUM DIOXIDE, ZINC OXIDE
Manufacturer
Aruba Aloe Balm NV
Country
United States (US)
ATC code
—
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
June 3, 2026

Packs & prices · 1

  • ndc11
    5367519102
    59 mL in 1 TUBE (53675-191-02)

Regulatory notes

UNII (FDA substance ID)
15FIX9V2JP
TITANIUM DIOXIDE
RxCUI 38323
DailyMed SPL labels
1 version tracked

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload
GET /v1/drugs/d1188fea-3990-4f8b-babd-f91b8d78eab3
GET /v1/drugs/d1188fea-3990-4f8b-babd-f91b8d78eab3?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "unii": {
    "unii": "15FIX9V2JP",
    "rxcui": "38323",
    "inchikey": "SOQBVABWOPYFQZ-UHFFFAOYSA-N",
    "display_name": "TITANIUM DIOXIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "52ba2f12-839f-cea1-e063-6394a90a5ae6": {
      "match": "brand_token",
      "title": "BROAD SPECTRUM SPF 50 SUNSCREEN (ZINC OXIDE) LOTION [SKIN DAMAGE INC.]",
      "spl_version": "1",
      "published_date": "2026-05-28"
    }
  },
  "productid": "53675-191_09866e0b-7358-2316-e063-6294a90a5009",
  "productndc": "53675-191",
  "dosage_form": "CREAM",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "TITANIUM DIOXIDE; ZINC OXIDE",
  "proprietary_name": "Broad Spectrum SPF 50 Babies Mineral Sunscreen",
  "active_ingred_unit": "mg/mL; mg/mL",
  "application_number": "M020",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "TITANIUM DIOXIDE, ZINC OXIDE",
  "start_marketing_date": "20200615",
  "active_numerator_strength": "100; 80"
}

See everything about titanium dioxide, zinc oxide.

This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.