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  5. Label Information: Skin Care Prescription

FDA Label for Skin Care Prescription

View Indications, Usage & Precautions

Table of Contents

    1. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    2. USES
    3. WARNINGS
    4. DIRECTIONS
    5. INACTIVE INGREDIENTS
    6. OTC - WHEN USING
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. OTC - ASK DOCTOR

Skin Care Prescription Product Label

The following document was submitted to the FDA by the labeler of this product Skin Care Physicians, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Package Label.Principal Display Panel



Active Ingredients:                                                                                                   PurposeAvobenzone 3.0%...................................................................................................Sunscreen (A)Octocrylene  4.0%...................................................................................................Sunscreen (B)Oxybenzone 6.0%...................................................................................................Suncreeen (A)Homosalate  15.0%.................................................................................................Sunscreen (B)Octisalate     5.0%...................................................................................................Sunscreen (B)

Uses



  • High UVB sunburn/UVA protection
  • for skin highly sensitive to sunburn
  • retains SPF after 80 minutes of activity

Warnings



For External use onlyUV exposure from the sun increases the risk of skin cancer, premature skin aging, and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing, and using sunscreen.

Directions



  • Apply liberally before sun exposure.
  • Apply and reapply as directed to avoid lowering protection.
  • Reapply after 80 minutes of swimming or sweating and after towel drying. Otherwise reapply at least every 2 hours.
  • Children under 6 months; ask a doctor.

Inactive Ingredients



Aqua; Acrylates/C10-30 Alkyl Acrylate Crosspolymer; Sorbitol; Marshmellow Extract,; Ivy Extract; Cucumber Extract; Elder Flower; Arnica Extract; EDTA; Aloe Barbadensis Leaf Juice; Isopropyl Palmitate; Stearic Acid; PEG100 Stearate; Dimethicone; Tocopheryl Acetate; Cetyl Alcohol; Glyceryl Stearate; C12-15 Alkyl Benzoate; Cetearyl Alcohol, Ceteareth-20; DMDM Hydantoim; Phenoxyethanol Ethylhexyl Glycerin; Triethanolamine; Acrylates/C12-22 Alkylmethacrylates Copolymer; Retinyl Palmitate


Otc - When Using



When using this product keep out of eyes.

Rinse with water to remove.

May stain some fabrics

Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Otc - Ask Doctor



Stop use and ask a doctor if skin rash occurs.


* Please review the disclaimer below.