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| Product NDC Code | 73054-127 | ||||
|---|---|---|---|---|---|
| Drug Name | Solara suncare - go vacation glow spf 30 |
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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 | LOTION | ||||
| Application Number | M020 | ||||
| Labeler Name | SOLARA SUNCARE, INC. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENT Zinc Oxide 18.9%
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 before each use apply generously and evenly 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reapply at least every two 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 Water (Aqua), Caprylic/Capric Triglyceride, Coconut Alkanes, Cetearyl Alcohol, Glycerin, Aloe Barbadensis Leaf Juice, Coco-Glucoside, Euterpe Oleracea (Acai) Fruit Extract, Camellia Sinensis (Green Tea) Leaf Extract, Helianthus Annuus (Sunflower) Sprout Extract, Hydrolyzed Jojoba Esters, Butyrospermum Parkii Nut Extract, Caesalpinea Spinosa Fruit Pod Extract, Caprylhydroxamic Acid, Glyceryl Caprylate, Cetearyl Glucoside, Caprylyl/Capric Glucoside, Coco-Caprylate/Caprate, Polyhydroxystearic Acid, Polyglyceryl-3 Polyricinoleate, Isostearic Acid, Lecithin, Dipotassium Glycyrrhizinate, Sodium Phytate, Propylene Glycol, Xanthan Gum, Sclerotium Gum, Phenoxyethanol, Sodium Benzoate, Tocopherol, Octyldodecanol, Sorbitan Oleate, Alumina, Magnesium Oxide, May Contain +/- : CI 77491, CI 77492, CI 77499 (Iron Oxides), Mica
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 VACATION GLOW SPF 30 ZINC OXIDE SODIUM BENZOATE ALUMINUM OXIDE PHENOXYETHANOL TOCOPHEROL FERRIC OXIDE RED WATER MEDIUM-CHAIN TRIGLYCERIDES COCONUT ALKANES CETOSTEARYL ALCOHOL GLYCERIN ALOE VERA LEAF COCO GLUCOSIDE ACAI GREEN TEA LEAF HELIANTHUS ANNUUS SPROUT HYDROLYZED JOJOBA ESTERS (ACID FORM) SHEA BUTTER CAESALPINIA SPINOSA FRUIT POD CAPRYLHYDROXAMIC ACID GLYCERYL CAPRYLATE CETEARYL GLUCOSIDE CAPRYLYL/CAPRYL OLIGOGLUCOSIDE COCO-CAPRYLATE/CAPRATE POLYHYDROXYSTEARIC ACID (2300 MW) POLYGLYCERYL-3 PENTARICINOLEATE ISOSTEARIC ACID LECITHIN, SUNFLOWER TRIPOTASSIUM GLYCYRRHIZINATE PHYTATE SODIUM ZINC OXIDE ZINC CATION PROPYLENE GLYCOL XANTHAN GUM BETASIZOFIRAN MAGNESIUM OXIDE FERROSOFERRIC OXIDE MICA OCTYLDODECANOL SORBITAN MONOOLEATE FERRIC OXIDE YELLOW
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.unit carton
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. 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