{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-10-28",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Introstem PrismaStem Face Shield Cream Octinoxate, Homosalate, Octisalate, Oxybenzone and Avobenzone OCTINOXATE OCTINOXATE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE OXYBENZONE OXYBENZONE AVOBENZONE AVOBENZONE WATER ALKYL (C12-15) BENZOATE GLYCERIN GLYCERYL MONOSTEARATE STEARIC ACID PEG-100 MONOSTEARATE PHENOXYETHANOL ETHYLHEXYLGLYCERIN POLYSORBATE 60 CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE TROLAMINE TOCOPHEROL VITAMIN A PALMITATE ALOE VERA LEAF GREEN TEA LEAF SODIUM PYRROLIDONE CARBOXYLATE WINE GRAPE EDETATE DISODIUM"
      ],
      "active_ingredient": [
        "Active Ingredients Octinoxate 7.40% Homosalate 6.20% Octisalate 5.00% Oxybenzone 3.10% Avobenzone 1.50%"
      ],
      "purpose": [
        "Purpose Sunscreen"
      ],
      "indications_and_usage": [
        "Uses • Helps prevent sunburn."
      ],
      "warnings": [
        "Warnings For external use only. Do not use on damaged or broken skin. Keep out of eyes. If contact occurs, rinse with water. If rash or irritation develops, discontinue use and consult your physician. Stop using this product and ask doctor if rash or redness develops and lasts. Keep out of reach of children. If accidental ingestion, call the Poison Control Center right away."
      ],
      "stop_use": [
        "Stop using this product and ask doctor if rash or redness develops and lasts."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. If accidental ingestion, call the Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions • After cleansing, apply liberally and evenly 15 minutes before sun exposure. Smooth over face and neck and chest daily for optimal results. • Reapply at least every two (2) hours. • Use water resistant sunscreen if swimming or sweating. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m.-2 p.m. • wear long-sleeved shirts, pants, hats and sunglasses. For children under 6 months of age: Ask doctor."
      ],
      "other_safety_information": [
        "Other Information Protect the product in this container from excessive heat and direct sun. Store at room temperature."
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Aqua, C12-15 Alkyl Benzoate, Glycerin, Glyceryl Stearate, Stearic Acid, PEG-100 Stearate, Phenoxyethanol, Ethylhexylglycerin, Polysorbate 60, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Carbomer, Triethanolamine, Fragrance, Tocopherol, Retinyl Palmitate, Aloe Barbadensis Leaf Extract, Camellia Sinensis Extract, Sodium PCA, Vitis Vinifera (Grape) Fruit Cell Extract, Disodium EDTA."
      ],
      "package_label_principal_display_panel": [
        "Package/Label Principal Display Panel – Carton Label INTROSTEM ® PRISMASTEM FACE SHIELD CREAM Crème Solaire Visage SPF 30 PrismaStem BROAD SPECTRUM SPF 30 infused with grape stem cell extract 60g ǀ 2.1oz www.introstem.com 20255 Corisco St. Chatsworth, CA 91311 image-01"
      ],
      "set_id": "dd91374a-e3fc-42f1-a660-86b32a0cc8b8",
      "id": "dd91374a-e3fc-42f1-a660-86b32a0cc8b8",
      "effective_time": "20250904",
      "version": "1",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "Introstem PrismaStem Face Shield Cream"
        ],
        "generic_name": [
          "OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE AND AVOBENZONE"
        ],
        "manufacturer_name": [
          "Innovation Brands Inc."
        ],
        "product_ndc": [
          "72104-042"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "OCTINOXATE",
          "HOMOSALATE",
          "OCTISALATE",
          "OXYBENZONE",
          "AVOBENZONE"
        ],
        "spl_id": [
          "dd91374a-e3fc-42f1-a660-86b32a0cc8b8"
        ],
        "spl_set_id": [
          "dd91374a-e3fc-42f1-a660-86b32a0cc8b8"
        ],
        "package_ndc": [
          "72104-042-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "4Y5P7MUD51",
          "V06SV4M95S",
          "4X49Y0596W",
          "95OOS7VE0Y",
          "G63QQF2NOX"
        ]
      }
    }
  ]
}