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Product NDC Code | 73054-109 | ||||
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Drug Name | Solara suncare - go mineral defense sport superfruit vitamin c plus aloe sheer sunscreen mist spf-30 unscented |
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Type | Brand | ||||
Pharm Class | Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE] |
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Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | SPRAY | ||||
Application Number | M020 | ||||
Labeler Name | SOLARA SUNCARE, INC. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENTS Non-Nano, Non-Coated Zinc Oxide 14%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.DIRECTIONS shake well before use hold container 4 to 6 inches from the skinapply Spray liberally and speard evenly by hand 15 minutes before sun exposure. Do not spray directly into face. Spray on hands then apply to face. Do not apply in windy conditions. Use in a well ventilated area. reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use asunscreen 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-sleeve shirts, pants, hats, and sunglasses children under 6 months: Ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS AQUA, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, BUTYLOCTYL SALICYLATE, CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, CAPRYLIC/CAPRIC TRIGLYCERIDE, BENTONITE, METHYL DIHYDROABIETATE, CETEARYL ALCOHOL, MANGIFERA INDICA (MANGO) FRUIT EXTRACT, ALOE LEAF JUICE, JOJOBA ESTERS, GLYCERIN, BISABOLOL, COCO-GLUCOSIDE, MICROCRYSTALLINE CELLULOSE, CELLULOSE GUM, CAPRYLHYDROXAMIC ACID, CAPRYLYL GLYCOL, POLYHYDROXYSTEARIC ACID, TOCOPHEROL
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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
Purpose
Information about the drug product’s indications for use.PURPOSE Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.SOLARA SUNCARE - GO MINERAL DEFENSE SPORT SUPERFRUIT VITAMIN C PLUS ALOE SHEER SUNSCREEN MIST SPF-30 UNSCENTED ZINC OXIDE WATER MEDIUM-CHAIN TRIGLYCERIDES GLYCERIN SUNFLOWER OIL TOCOPHEROL BUTYLOCTYL SALICYLATE SAFFLOWER OIL BENTONITE METHYL DIHYDROABIETATE CETOSTEARYL ALCOHOL MANGO ALOE VERA LEAF HYDROGENATED JOJOBA OIL/JOJOBA OIL, RANDOMIZED (IODINE VALUE 40-44) LEVOMENOL COCO GLUCOSIDE CAPRYLYL GLYCOL MICROCRYSTALLINE CELLULOSE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM CAPRYLHYDROXAMIC ACID POLYHYDROXYSTEARIC ACID (2300 MW) ZINC OXIDE ZINC CATION
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.01b LBL_Go_Sheer Sunscreen Mist_SPF30_unscented_6oz
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If product is swallowed, get medical help or contact Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.QUESTIONS OR COMMENTS 1-855-859-1600 (9am – 5pm ET)
Storage and handling
Information about safe storage and handling of the drug product.OTHER INFORMATION Protect this product from excessive heat and direct sun.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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. Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120F. Stop use and ask a doctor if rash occurs
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API