The Tinted Serum Broad Spectrum SPF 50

UNIISPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerRationale Group Pty Ltd

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
8310800100
1 BOTTLE, DROPPER in 1 BOX (83108-001-00) / 30 mL in 1 BOTTLE, DROPPER
ndc11
8310800103
3 mL in 1 BOTTLE, DROPPER (83108-001-03)
ndc11
8310800105
5 mL in 1 BOTTLE, DROPPER (83108-001-05)
ndc11
8310800113
3 mL in 1 BOTTLE (83108-001-13)
ndc11
8310800115
5 mL in 1 BOTTLE (83108-001-15)

Annotations

UNII (FDA Substance ID)

SOI2LOH54Z

ZINC OXIDE

RxCUI 11423

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "SOI2LOH54Z",
    "rxcui": "11423",
    "inchikey": "RNWHGQJWIACOKP-UHFFFAOYSA-N",
    "display_name": "ZINC OXIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "f2b9a49d-e91f-416d-a031-15bbde005d2f": {
      "match": "brand_token",
      "title": "THE INDIGO CALMING (COLLOIDAL OATMEAL) CREAM [TATCHA INC.]",
      "spl_version": "5",
      "published_date": "2026-05-28"
    }
  },
  "productid": "83108-001_450e05a9-b559-c077-e063-6394a90a55ca",
  "productndc": "83108-001",
  "dosage_form": "EMULSION",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "ZINC OXIDE",
  "proprietary_name": "The Tinted Serum Broad Spectrum SPF 50",
  "active_ingred_unit": "mg/mL",
  "application_number": "M020",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "ZINC OXIDE",
  "start_marketing_date": "20221125",
  "active_numerator_strength": "240"
}

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