{
  "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": "2026-08-11",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 2
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Herpecin L Zinc Oxide, Dimethicone SAFFLOWER OIL SOYBEAN OIL ISOSTEARIC ACID POLYHYDROXYSTEARIC ACID (2300 MW) SUNFLOWER OIL SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL CERESIN BUTYLOCTYL SALICYLATE C10-30 CHOLESTEROL/LANOSTEROL ESTERS TRIBEHENIN MICROCRYSTALLINE WAX SILICON DIOXIDE LEMON BALM OIL .ALPHA.-TOCOPHEROL BISABOLOL LAUROYL LYSINE ZINGIBER OFFICINALE (GINGER) ROOT OIL ALOE BARBADENSIS LEAF JUICE TETRAHEXYLDECYL ASCORBATE CAPRYLIC/CAPRIC TRIGLYCERIDE DIMETHICONE DIMETHICONE ZINC OXIDE ZINC OXIDE POLYGLYCERYL-3 RICINOLEATE ALPHA-TOCOPHEROL ACETATE LECITHIN, SUNFLOWER"
      ],
      "active_ingredient": [
        "Active ingredients Zinc Oxide 20% Dimethicone 6%"
      ],
      "purpose": [
        "Purpose Sunscreen Skin protectant"
      ],
      "indications_and_usage": [
        "Uses helps protect and relieve cold sores/fever blisters helps prevent sunburn on lips relieves dry chapped lips"
      ],
      "warnings": [
        "Warnings For external use only"
      ],
      "do_not_use": [
        "Do not use on broken skin if you are allergic to any ingredient in this product"
      ],
      "when_using": [
        "When using this product keep out of eyes. Rinse with water to remove. apply only to affected areas avoid applying directly inside your mouth do not share this product with anyone since this may spread infection"
      ],
      "stop_use": [
        "Stop use and ask a doctor if rash occurs, condition worsens or does not improve within 7 days"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions adults and children 12 years or over: at first sign of a cold sore, apply liberally at least 4 times a day to affected area on lips as a protectant, aply liberally to lips as often as needed or at least twice daily for cracking and dryness continue to cover lips until absorbed apply liberally 15 minutes before sun exposure and at least every 2 hours when in sun use a water resistant sunscreen on lips 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, regularily use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in sun, especially from 10am - 2pm Wear long-sleeved shirts, pants, hats and sunglasses children under 12 years : ask a doctor"
      ],
      "spl_unclassified_section": [
        "Other information protect the product in this container from excessive heat and direct sun"
      ],
      "inactive_ingredient": [
        "Inactive ingredients helianthus annuus (sunflower) seed oil, ozokerite, butyloctyl salicylate, caprylic/capric triglyceride, simmondsia chinensis (jojoba) seed oil, C10-30 cholesterol/lanosterol esters, tribehenin, microcrystalline wax, polyhydroxystearic acid, silica, fragrance (parfum), tetrahexyldecyl ascorbate, lauroyl lysine, zingibar officinale (ginger) root extract, melissa officinalis extract, aloe barbadensis leaf extract, tocopherol, tocopheryl acetate, carthamus tinctorius (safflower) seed oil, glycine soja (soybean) oil, polyglyceryl-3 polyricinoleate, isostearic acid, lecithin, bisabolol"
      ],
      "package_label_principal_display_panel": [
        "PDP"
      ],
      "set_id": "488a29c3-dd97-af1a-e063-6394a90aba7f",
      "id": "48838b8d-ebd8-cd22-e063-6294a90a6802",
      "effective_time": "20260126",
      "version": "1",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Herpecin L"
        ],
        "generic_name": [
          "ZINC OXIDE, DIMETHICONE"
        ],
        "manufacturer_name": [
          "Focus Consumer Healthcare, LLC"
        ],
        "product_ndc": [
          "71687-7774"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "DIMETHICONE",
          "ZINC OXIDE"
        ],
        "spl_id": [
          "48838b8d-ebd8-cd22-e063-6294a90a6802"
        ],
        "spl_set_id": [
          "488a29c3-dd97-af1a-e063-6394a90aba7f"
        ],
        "package_ndc": [
          "71687-7774-2",
          "71687-7774-1"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0371687777326"
        ],
        "nui": [
          "N0000010282"
        ],
        "pharm_class_pe": [
          "Skin Barrier Activity [PE]"
        ],
        "unii": [
          "92RU3N3Y1O",
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}