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Solara suncare - pout protector spf-15 - Medication Information

Product NDC Code 73054-104
Drug Name

Solara suncare - pout protector spf-15

Type Brand
Pharm Class Copper Absorption Inhibitor [EPC],
Decreased Copper Ion Absorption [PE]
Active Ingredients
Zinc oxide 11 g/100ml
Route TOPICAL
Dosage Form CREAM
Application Number part352
Labeler Name SOLARA SUNCARE, INC.
Packages
Package NDC Code Description
73054-104-11 1 tube in 1 box (73054-104-11) / 10 ml in 1 tube (73054-104-01)
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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 Aqua (Water), Bisabolol, Bis-Diglyceryl Polyacyladipate-2, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Cetearyl Ethylhexanoate, Cetearyl Nonanoate, Cocos Nucifera (Coconut) Oil, Ethylhexyl Palmitate, Fructose, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Helianthus, Annuus (Sunflower) Seed Wax, Isostearic Acid, Lecithin, Mentha Spicata (Spearmint) Oil, Palmitoyl Tripeptide-1, Palmitoyl Tripeptide-38, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Portulaca Pilosa Extract (Purslane), Rubus Laciniatus (Blackberry) extract, Sorbitan Isostearate, Sorbitol/ Sebacic Acid Copolymer Behenate, Stearic Acid, Sucrose Cocoate (Stevia), Tiare Flower Extract, Tocopherol, Tribehenin , Withania Somnifera (Ashwaganda) Root Extract

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 - POUT PROTECTOR SPF-15 ZINC OXIDE ISOSTEARIC ACID LECITHIN, SUNFLOWER SPEARMINT OIL PALMITOYL TRIPEPTIDE-1 PALMITOYL LYSYLDIOXYMETHIONYLLYSINE WATER .ALPHA.-BISABOLOL, (+/-)- BIS-DIGLYCERYL POLYACYLADIPATE-2 SHEA BUTTER MEDIUM-CHAIN TRIGLYCERIDES CETEARYL ETHYLHEXANOATE CETEARYL NONANOATE COCONUT OIL ETHYLHEXYL PALMITATE FRUCTOSE GLYCERIN SUNFLOWER OIL HELIANTHUS ANNUUS SEED WAX POLYGLYCERYL-3 RICINOLEATE POLYHYDROXYSTEARIC ACID (2300 MW) PORTULACA PILOSA WHOLE RUBUS LACINIATUS WHOLE SORBITAN ISOSTEARATE SORBITOL SEBACIC ACID BEHENIC ACID STEARIC ACID SUCROSE COCOATE GARDENIA TAITENSIS FLOWER TOCOPHEROL TRIBEHENIN WITHANIA SOMNIFERA ROOT 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_Pout Protector

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