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  5. Label Information: Eight Hour Cream Targeted Sun Defense Spf 50

FDA Label for Eight Hour Cream Targeted Sun Defense Spf 50

View Indications, Usage & Precautions

Table of Contents

    1. DESCRIPTION
    2. INDICATIONS AND USAGE
    3. WARNINGS
    4. OTC - ACTIVE INGREDIENT
    5. INACTIVE INGREDIENT
    6. DOSAGE & ADMINISTRATION
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. OTC - PURPOSE
    9. OTC - WHEN USING

Eight Hour Cream Targeted Sun Defense Spf 50 Product Label

The following document was submitted to the FDA by the labeler of this product Elizabeth Arden, 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.

Description



Target over-exposed areas such as lips, nose, earlobes, even scars to shield from the burning and aging effects of UVA and UVB rays. Eight Hour Cream hydrating benefits sooth and smooth for up to 8 hours.

Oil-free. Water-resistant. PABA-free. Non-acnegenic. Perspiration-resistant. Suitable for all skin types. Ophthalmologist, clinically and dermatologist tested.

Uses: Helps prevent sunburn. Higher SPF gives more sunburn protection. Retains SPF after 40 minutes of swimming or perspiring.

Sun Alert: Limiting sun exposure, wearing protective clothing and using sunscreens may reduce the risk of skin cancer and other harmful effects of the sun.


Indications And Usage



Directions: Apply liberally and evenly to targeted areas 30 minutes before sun exposure and as needed. Reapply after 40 minutes of swimming or perspiring, and after towel drying. Otherwise, reapply at least every 2 hours. Children under 6 months of age: ask a doctor.


Warnings



Warnings: For external use only. When using this product, keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash or irritation develops and lasts. Keep out of reach of children. If swallowed, get medical help or contact a poison controll center right away.


Otc - Active Ingredient



Active Ingredients: Homosalate 7.5% w/w, Octinoxate 7.5% w/w, Octocrylene 5.0% w/w, Oxybenzone 4.0% w/w, Avobenzone 2.0% w/w.


Inactive Ingredient



Other Ingredients: Octyldodecyl Myristate, Polyethylene, Phenyl Trimethicone, Tocopheryl Acetate, Caprylyl Glycol, Parfum/Fragrance, Citral, Citronellol, Geraniol, Limonene, Linalool, Phenoxyethanol.


Dosage & Administration



Apply evenly and liberally to targeted areas.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.


Otc - Purpose



Helps prevent sunburn. Higher SPF gives more sun protection.


Otc - When Using



Keep out of eyes.


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