View Drug - Sun Bum Tinted Sunscreen Lip Balm Broad Spectrum SPF 15 - Nude Beach, Sun Bum Tinted Sunscreen Lip Balm Broad Spectrum SPF 15 - Nude Beach Carded
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Sun Bum Tinted Sunscreen Lip Balm Broad Spectrum SPF 15 - Nude Beach, Sun Bum Tinted Sunscreen Lip Balm Broad Spectrum SPF 15 - Nude Beach Carded

Generic: HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE

100%
Basic Information
Manufacturer
Sun Bum, LLC
Product Type
HUMAN OTC DRUG
Route of Administration
TOPICAL
FDA Set ID
3ac48eef-f651-af96-e063-6294a90a501e
Purpose
Purpose Sunscreen
Indications & 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
Warnings For external use only Do not use on damaged or broken skin When using this product keep out of eyes.

Rinse with water to remove.

Stop use and ask a doctor if rash occurs Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.
Technical Data
{
    "spl_product_data_elements": [
        "Sun Bum Tinted Sunscreen Lip Balm Broad Spectrum SPF 15 - Nude Beach HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL POLYHYDROXYSTEARIC ACID (2300 MW) THEOBROMA GRANDIFLORUM SEED BUTTER POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) RED 7 BUTYROSPERMUM PARKII (SHEA) BUTTER SILICA TITANIUM DIOXIDE COPERNICIA CERIFERA (CARNAUBA) WAX SOYBEAN OIL TIN OXIDE OCTOCRYLENE OCTOCRYLENE OLEA EUROPAEA (OLIVE) FRUIT OIL HYDROLYZED JOJOBA ESTERS STEVIA REBAUDIUNA LEAF COCOS NUCIFERA (COCONUT) OIL RICINUS COMMUNIS (CASTOR) SEED OIL CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL OCTYLDODECYL OLEATE TOCOPHEROL ZINC OXIDE ZINC OXIDE MICA HOMOSALATE HOMOSALATE CAPRYLIC/CAPRIC TRIGLYCERIDE SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL OCTISALATE OCTISALATE BEESWAX EUPHORBIA CERIFERA (CANDELILLA) WAX ALOE BARBADENSIS LEAF LIMNANTHES ALBA (MEADOWFOAM) SEED OIL CARMINIC ACID FERRIC OXIDE RED Sun Bum Tinted Sunscreen Lip Balm Broad Spectrum SPF 15 - Nude Beach Carded HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE CARMINIC ACID HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL POLYHYDROXYSTEARIC ACID (2300 MW) THEOBROMA GRANDIFLORUM SEED BUTTER POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) TITANIUM DIOXIDE COPERNICIA CERIFERA (CARNAUBA) WAX SOYBEAN OIL TIN OXIDE OCTOCRYLENE OCTOCRYLENE OLEA EUROPAEA (OLIVE) FRUIT OIL HYDROLYZED JOJOBA ESTERS STEVIA REBAUDIUNA LEAF COCOS NUCIFERA (COCONUT) OIL RICINUS COMMUNIS (CASTOR) SEED OIL CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL OCTYLDODECYL OLEATE TOCOPHEROL ZINC OXIDE ZINC OXIDE MICA HOMOSALATE HOMOSALATE CAPRYLIC/CAPRIC TRIGLYCERIDE SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL OCTISALATE OCTISALATE BEESWAX EUPHORBIA CERIFERA (CANDELILLA) WAX ALOE BARBADENSIS LEAF LIMNANTHES ALBA (MEADOWFOAM) SEED OIL SILICA RED 7 BUTYROSPERMUM PARKII (SHEA) BUTTER FERRIC OXIDE RED"
    ],
    "active_ingredient": [
        "Active Ingredients Homosalate 10%, Octisalate 5%, Octocrylene 3%, Zinc Oxide 2.9%"
    ],
    "purpose": [
        "Purpose Sunscreen"
    ],
    "indications_and_usage": [
        "Uses \u2022 helps prevent sunburn \u2022 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": [
        "Warnings For external use only Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately."
    ],
    "keep_out_of_reach_of_children": [
        "Warnings Keep Out Of Reach Of Children"
    ],
    "instructions_for_use": [
        "Directions \u2022 shake well before use \u2022 apply liberally 15 minutes before sun exposure \u2022 reapply: \u2022 after 80 minutes of swimming or sweating \u2022 immediately after towel drying \u2022 at least every 2 hours \u2022 children under 6 months of age: ask a doctor \u2022 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: \u2022 limit time in the sun, especially from 10 a.m.- 2 p.m. \u2022 wear long-sleeved shirts, pants, hats and sunglasses"
    ],
    "dosage_and_administration": [
        "Directions \u2022 apply liberally 15 minutes before sun exposure"
    ],
    "other_safety_information": [
        "Other Information protect this product from excessive heat and direct sun"
    ],
    "inactive_ingredient": [
        "Inactive Ingredients Beeswax, Cocos Nucifera (Coconut) Oil, Butyrospermum Parkii (Shea) Butter, Ricinus Communis (Castor) Seed Oil, Caprylic/Capric Triglyceride, Olea Europaea (Olive) Fruit Oil, Theobroma Grandiflorum Seed Butter, Copernicia Cerifera (Carnauba) Wax, Euphorbia Cerifera (Candelilla) Wax, Polymethylsilsesquioxane, Flavor, Mica, Iron Oxides, Helianthus Annuus (Sunflower) Seed Oil, Aloe Barbadensis Leaf Extract, Glycine Soja (Soybean) Oil, Jojoba Esters, Limnanthes Alba (Meadowfoam) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Carthamus Tinctorius (Safflower) Seed Oil, Polyhydroxystearic Acid, Stevia Rebaudiana Extract, Octyldodecyl Oleate, Tocopherol, Tin Oxide, Titanium Dioxide, Silica, Carmine, Red 7 Lake"
    ],
    "questions": [
        "Questions? 1-877-978-6286"
    ],
    "package_label_principal_display_panel": [
        "Sun Bum Tinted Sunscreen Lip Balm Broad Spectrum SPF 15 - Nude Beach Primary Artwork Primary Artwork",
        "Sun Bum Tinted Sunscreen Lip Balm Broad Spectrum SPF 15 - Nude Beach Carded Primary Artwork Primary Artwork"
    ],
    "set_id": "3ac48eef-f651-af96-e063-6294a90a501e",
    "id": "3c5cc048-ba87-3cf5-e063-6294a90a9dfb",
    "effective_time": "20250814",
    "version": "3",
    "openfda": {
        "application_number": [
            "M020"
        ],
        "brand_name": [
            "Sun Bum Tinted Sunscreen Lip Balm Broad Spectrum SPF 15 - Nude Beach",
            "Sun Bum Tinted Sunscreen Lip Balm Broad Spectrum SPF 15 - Nude Beach Carded"
        ],
        "generic_name": [
            "HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE"
        ],
        "manufacturer_name": [
            "Sun Bum, LLC"
        ],
        "product_ndc": [
            "69039-738",
            "69039-739"
        ],
        "product_type": [
            "HUMAN OTC DRUG"
        ],
        "route": [
            "TOPICAL"
        ],
        "substance_name": [
            "HOMOSALATE",
            "OCTISALATE",
            "OCTOCRYLENE",
            "ZINC OXIDE"
        ],
        "spl_id": [
            "3c5cc048-ba87-3cf5-e063-6294a90a9dfb"
        ],
        "spl_set_id": [
            "3ac48eef-f651-af96-e063-6294a90a501e"
        ],
        "package_ndc": [
            "69039-738-01",
            "69039-739-01",
            "69039-739-02"
        ],
        "is_original_packager": [
            true
        ],
        "upc": [
            "0871760007482",
            "0871760004337"
        ],
        "unii": [
            "SOI2LOH54Z",
            "4X49Y0596W",
            "V06SV4M95S",
            "5A68WGF6WM"
        ]
    }
}