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| Product NDC Code | 73054-102 | ||||||
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| Drug Name | Solara suncare - clean freak spf-30 naturally scented |
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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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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENTS Non-Nano, Non-Coated Zinc Oxide 20%
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 or knead before each use apply generously and evenly 15 minutes before sun exposure reapply: after 40 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 Water (Aqua), Caprylic/Capric Triglyceride, Glycerin, C13-14 Alkane, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Butyrospermum Parkii (Shea) Butter, Coco-Caprylate, Propanediol, Cocos Nucifera (Coconut) Oil, Hydrogenated Castor Oil, Magnesium Sulfate, Helianthus Annuus (Sunflower) Seed Wax, Squalane, Helianthus Annuus (Sunflower) Seed Oil, Tocopherol, Withania Somnifera (Ashwagandha) Root Extract, Perilla Frutescens (Mint) Leaf Extract, Punica Granatum Flower Extract, Prunus Amygdalus Dulcis (Sweet Almond) Fruit Extract, Prunus Armeniaca (Apricot) Fruit Extract, Avena Sativa (Oat) Kernel Extract, Gardenia Taitensis (Tahitian Gardenia) Flower Extract, Rubus Idaeus Leaf Extract, Impatiens Balsamina Flower Extract, Potassium Sorbate, Terminalia Ferdinandiana Fruit Extract, Citrus Limon (Lemon) Peel Extract, Cocos Nucifera Fruit Extract, Cucumis Melo Cantalupensis Fruit Extract, Dianthus Caryophyllus Flower Extract, Fragaria Ananassa (Strawberry) Fruit Extract, Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, Musa Sapientum (Banana) Fruit Extract, Vanilla Planifolia Fruit Extract, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Cetyl Palmitate, Sorbitan Palmitate, Caprylyl Glycol, Phenylpropanol, Sorbitan Olivate, Isostearic Acid, Lecithin, Fructose, Benzyl Salicylate*, Amyl Cinnamal*, Hexyl Cinnamal*, Coumarin*, Linalool* (*0.004% or less, naturally occurring in plant extracts)
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 - CLEAN FREAK SPF-30 NATURALLY SCENTED ZINC OXIDE WATER MEDIUM-CHAIN TRIGLYCERIDES GLYCERIN C13-14 ISOPARAFFIN POLYGLYCERYL-4 ISOSTEARATE SHEA BUTTER COCO-CAPRYLATE PROPANEDIOL COCONUT OIL HYDROGENATED CASTOR OIL MAGNESIUM SULFATE ANHYDROUS HELIANTHUS ANNUUS SEED WAX SQUALANE SUNFLOWER OIL TOCOPHEROL WITHANIA SOMNIFERA ROOT PERILLA FRUTESCENS LEAF PUNICA GRANATUM FLOWER ALMOND APRICOT OAT GARDENIA TAITENSIS FLOWER RUBUS IDAEUS LEAF IMPATIENS BALSAMINA FLOWER POTASSIUM SORBATE KAKADU PLUM LEMON PEEL COCONUT JUICE CUCUMBER CANTALOUPE DIANTHUS CARYOPHYLLUS FLOWER STRAWBERRY LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWERING TOP BANANA VANILLA POLYGLYCERYL-3 RICINOLEATE POLYHYDROXYSTEARIC ACID (2300 MW) CETYL PALMITATE SORBITAN MONOPALMITATE CAPRYLYL GLYCOL PHENYLPROPANOL SORBITAN OLIVATE ISOSTEARIC ACID LECITHIN, SUNFLOWER FRUCTOSE 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 UC_Clean Freak_Scented_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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.OTHER INFORMATION Protect this product from excessive heat and direct sun.
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)
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