{
  "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": "2026-10-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Spot Defy Sulfur WATER KAOLIN CETOSTEARYL ALCOHOL GLYCERYL STEARATE SE GLYCERIN BUTYLENE GLYCOL BENTONITE ACACIA PHENOXYETHANOL NIACINAMIDE MALTODEXTRIN ETHYLHEXYLGLYCERIN SODIUM PYRROLIDONE CARBOXYLATE XANTHAN GUM .ALPHA.-TOCOPHEROL ACETATE SYRINGA VULGARIS FLOWER GLYCYRRHIZINATE DIPOTASSIUM CENTELLA ASIATICA WHOLE HIBISCUS ROSA-SINENSIS FLOWER LAVANDULA ANGUSTIFOLIA WHOLE OREGANO THYME SULFUR SULFUR"
      ],
      "active_ingredient": [
        "active ingredient sulfur 5%"
      ],
      "purpose": [
        "purpose acne treatment"
      ],
      "indications_and_usage": [
        "indications clears acne pimples"
      ],
      "warnings": [
        "warnings for external use only. keep out of reach of children. when using this product skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. if irritation occurs, only use one topical acne medication at a time. do not use on broken skin or large areas of the skin. when using this product apply only to areas with acne."
      ],
      "keep_out_of_reach_of_children": [
        "keep out of reach of children."
      ],
      "when_using": [
        "when using this product skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. if irritation occurs, only use one topical acne medication at a time.",
        "when using this product apply only to areas with acne."
      ],
      "do_not_use": [
        "do not use on broken skin or large areas of the skin."
      ],
      "dosage_and_administration": [
        "directions clean the skin thoroughly before applying this product. cover the entire affected area with a thin layer at night. if bothersome dryness or peeling occurs, reduce application to every other night."
      ],
      "inactive_ingredient": [
        "inactive ingredients Water (Aqua, Eau), Kaolin, Cetearyl Alcohol, Glyceryl Stearate SE, Glycerin, Butylene Glycol, Bentonite, Acacia Senegal Gum, Phenoxyethanol, Niacinamide, Maltodextrin, Ethylhexylglycerin, Sodium PCA, Xanthan Gum, Tocopheryl Acetate, Syringa Vulgaris (Lilac) Extract, Quartz, Dipotossium Glycyrrhizate, Centella Asiatica Extract, Hibiscus Rosa-Sinensis Flower Extract, Lavandula Angustifolia (Lavender) Extract, Origanum Vulgare Leaf Extract, Thymus Vulgaris (Thyme) Extract"
      ],
      "questions": [
        "questions? call 1.800.433.6650 monday - friday 7:30am - 4:30 pm mst"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel – 15 mL Carton Label bioelements spot defy™ 5% sulfur overnight spot treatment to clear active acne blemishes ACNE ACTIVIST 15 mL / .5 fl oz Principal Display Panel – 15 mL Carton Label"
      ],
      "set_id": "6f35f950-8d04-4181-a897-5679fde1e2d9",
      "id": "462acf75-cc59-2738-e063-6294a90a47de",
      "effective_time": "20251217",
      "version": "3",
      "openfda": {
        "application_number": [
          "M006"
        ],
        "brand_name": [
          "Spot Defy"
        ],
        "generic_name": [
          "SULFUR"
        ],
        "manufacturer_name": [
          "Bioelements, Inc."
        ],
        "product_ndc": [
          "49825-200"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "SULFUR"
        ],
        "rxcui": [
          "422938"
        ],
        "spl_id": [
          "462acf75-cc59-2738-e063-6294a90a47de"
        ],
        "spl_set_id": [
          "6f35f950-8d04-4181-a897-5679fde1e2d9"
        ],
        "package_ndc": [
          "49825-200-20",
          "49825-200-10"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "70FD1KFU70"
        ]
      }
    }
  ]
}