{
  "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": "2026-10-30",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Calendula Essential Hydrating Broad Spectrum SPF 30 Sunscreen Zinc Oxide ZINC OXIDE ZINC OXIDE CAPRYLIC/CAPRIC TRIGLYCERIDE LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL HYDROLYZED JOJOBA ESTERS POLYGONUM AVICULARE TOP CAPRYLHYDROXAMIC ACID BISABOLOL GLYCERYL STEARATE GLYCERYL CAPRATE BORAGO OFFICINALIS WHOLE LINALYL ACETATE WATER POLYHYDROXYSTEARIC ACID (2300 MW) POLYGLYCERYL-6 DISTEARATE ALLANTOIN CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) DIHEPTYL SUCCINATE ROSA DAMASCENA FLOWER OIL PROPANEDIOL LINALOOL SODIUM PCA TOCOPHEROL GLYCERIN SORBITAN SESQUIOLEATE SODIUM STEAROYL GLUTAMATE POLYGLYCERYL-6 POLYRICINOLEATE BUTYLOCTYL SALICYLATE HYALURONIC ACID SQUALANE GLYCINE SOJA (SOYBEAN) OIL UNSAPONIFIABLES PONGAMIA PINNATA SEED CITRUS AURANTIUM AMARA (BITTER ORANGE) PEEL OIL BETAINE STARCH, TAPIOCA ALOE BARBADENSIS LEAF JUICE CALENDULA OFFICINALIS FLOWER JOJOBA OIL XANTHAN GUM TAGETES MINUTA FLOWER OIL"
      ],
      "active_ingredient": [
        "Active Ingredients Purpose Zinc Oxide 15% ..............................................Sunscreen"
      ],
      "purpose": [
        "Purpose Purpose Zinc Oxide 15%..............................................Sunscreen"
      ],
      "indications_and_usage": [
        "Uses Helps prevent sunburn if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun"
      ],
      "warnings": [
        "For external use only"
      ],
      "do_not_use": [
        "Do not use on damaged or broken skin"
      ],
      "when_using": [
        "keep outof eyes. Rinse with water to remove"
      ],
      "ask_doctor": [
        "Stop use and ask a doctor if rash occurs"
      ],
      "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 Directions Apply liberally 15 minutes before sun exposure Reapply at least every 2 hours use a 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 Children under 6 months of age: ask a doctor"
      ],
      "other_safety_information": [
        "Protect the product in this container from excessive heat and direct sun"
      ],
      "questions": [
        "Questions or Commets? call toll free 646-979-3997"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients: Water (Aqua), Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Feruloyl Soy Glycerides, Polyglyceryl-6 Distearate, Glycerin, Betaine, Propanediol, Tapioca Starch, Glyceryl Stearate, Sorbitan Sesquioleate, Aloe Barbadensis Leaf Juice, Calendula Officinalis Flower Extract, Allantoin, Bisabolol, Hyaluronic Acid, Squalane, Simmondsia Chinensis (Jojoba) Seed Oil, Pongamia Pinnata Seed Extract, Lavandula Angustifolia (Lavender) Oil, Glyceryl Caprylate, Dilheptyl Succinate, Polyhydroxystearic Acid, Sodium Stearoyl Glutamate, Tocopheryl Acetate, Xanthan Gum, Capryloyl Glycerin/Sebacic Acid Copolymer, Sodium PCA, Tocopherol, Caprylhydroxamic Acid, Glycine Soja (Soybean) Oil, Citric Acid, Iron Oxides (Cl 77492), Citrus Aurantium Amara (Bitter Orange) Peel Oil, Rosa Damascena Flower Oil, Tagetes Minuta Flower Oil, Borago Officinalis (Common Borage), Jojoba Esters, Polyglyceryl-6 Polyricinoleate, Silica, Polygonum Aviculare Extract, Linalool, Linalyl Acetate, Lavandula Oil / Extract"
      ],
      "package_label_principal_display_panel": [
        "PDP DFB"
      ],
      "set_id": "41d75815-e281-bf88-e063-6294a90afeff",
      "id": "41d75815-e282-bf88-e063-6294a90afeff",
      "effective_time": "20251023",
      "version": "1",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "Calendula Essential Hydrating Broad Spectrum SPF 30 Sunscreen"
        ],
        "generic_name": [
          "ZINC OXIDE"
        ],
        "manufacturer_name": [
          "Naturopathica Holistic Health"
        ],
        "product_ndc": [
          "64657-007"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE"
        ],
        "spl_id": [
          "41d75815-e282-bf88-e063-6294a90afeff"
        ],
        "spl_set_id": [
          "41d75815-e281-bf88-e063-6294a90afeff"
        ],
        "package_ndc": [
          "64657-007-01",
          "64657-007-02"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}