COOLA CLASSIC SUNSCREEN FRAGRANCE FREE

NDC product · U.S. Food and Drug Administration (openFDA) · United States

Product NDC 79753-045
Package NDC 79753-045-72
Application number M020
SPL ID 45ede361-ecc1-0474-e063-6294a90a9c2d
SPL set ID cfc21b1a-4a26-1573-e053-2995a90a2d50
UNII V06SV4M95S
UNII G63QQF2NOX
UNII 5A68WGF6WM
UNII 4X49Y0596W

What the source publishes

Labeler: COOLA, LLC
Active ingredients: Avobenzone, Homosalate, Octisalate, Octocrylene
Form: LOTION
Routes: TOPICAL
Administrative status: present-in-source-snapshot
Marketing status: OTC MONOGRAPH DRUG
Product type: HUMAN OTC DRUG
Prescription: Non-prescription

Names this record is found by

Complete source data

us:fda:ndc:79753-045_45ede361-ecc1-0474-e063-6294a90a9c2d

{
  "name": "COOLA CLASSIC SUNSCREEN FRAGRANCE FREE",
  "splId": "45ede361-ecc1-0474-e063-6294a90a9c2d",
  "labels": [
    {
      "setId": "cfc21b1a-4a26-1573-e053-2995a90a2d50",
      "labelUrl": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cfc21b1a-4a26-1573-e053-2995a90a2d50",
      "labelPdfUrl": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=cfc21b1a-4a26-1573-e053-2995a90a2d50"
    }
  ],
  "routes": [
    "TOPICAL"
  ],
  "labeler": "COOLA, LLC",
  "finished": true,
  "packaging": [
    {
      "sample": false,
      "description": "946 mL in 1 BOTTLE (79753-045-72)",
      "package_ndc": "79753-045-72",
      "identifierStatus": "well-formed",
      "marketing_start_date": "20180101"
    }
  ],
  "productId": "79753-045_45ede361-ecc1-0474-e063-6294a90a9c2d",
  "useDomain": "unknown",
  "dosageForm": "LOTION",
  "productNdc": "79753-045",
  "deaSchedule": null,
  "genericName": "Avobenzone, Homosalate, Octisalate, Octocrylene",
  "productType": "HUMAN OTC DRUG",
  "listingStatus": "present-in-source-snapshot",
  "targetSpecies": [],
  "approvalStatus": "not-established-by-ndc-listing",
  "labelAssociation": "openFDA-harmonized-set-ids; not a product-level approval match",
  "marketingEndDate": null,
  "activeIngredients": [
    {
      "name": "HOMOSALATE",
      "strength": "100 mg/mL"
    },
    {
      "name": "AVOBENZONE",
      "strength": "30 mg/mL"
    },
    {
      "name": "OCTOCRYLENE",
      "strength": "80 mg/mL"
    },
    {
      "name": "OCTISALATE",
      "strength": "45 mg/mL"
    }
  ],
  "applicationNumber": "M020",
  "marketingCategory": "OTC MONOGRAPH DRUG",
  "stateRestrictions": {
    "status": "not-collected",
    "observations": []
  },
  "useDomainEvidence": {
    "basis": "unreviewed",
    "field": null,
    "value": null,
    "version": 1,
    "sourceId": "us.fda.ndc"
  },
  "marketingStartDate": "20180101",
  "targetSpeciesStatus": "not-reported",
  "prescriptionCategory": "non-prescription",
  "harmonizedIdentifiers": {
    "unii": [
      "V06SV4M95S",
      "G63QQF2NOX",
      "5A68WGF6WM",
      "4X49Y0596W"
    ],
    "spl_set_id": [
      "cfc21b1a-4a26-1573-e053-2995a90a2d50"
    ],
    "manufacturer_name": [
      "COOLA, LLC"
    ],
    "is_original_packager": [
      true
    ]
  },
  "listingExpirationDate": "20261231"
}

NDC Directory

U.S. Food and Drug Administration / openFDA

Retrieved: November 12, 2026
Licence: CC0 1.0
Source id: us.fda.ndc

Official source

What this source does not establish

Complete published endpoint, not a claim that FDA lists every medicine used in the US.
NDC listing, marketing category and application-number assertions are not proof of approval.
Tentative approval, discontinued products and historical submissions remain distinct.
Official document links only; linked documents have not been relicensed or mirrored.
No state restrictions, individual eligibility, or prescribing recommendations inferred.
UNII and RxNorm identifiers are source-asserted openFDA harmonization at record scope; arrays do not pair identifiers to individual products or ingredients, and are not GSID/PhPID or substitution evidence.

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