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  5. Label Information: Sun Defense Spf 30

FDA Label for Sun Defense Spf 30

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. OTC - KEEP OUT OF REACH OF CHILDREN
    4. INDICATIONS & USAGE
    5. WARNINGS
    6. DOSAGE & ADMINISTRATION
    7. INACTIVE INGREDIENT
    8. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sun Defense Spf 30 Product Label

The following document was submitted to the FDA by the labeler of this product Kamins Dermatologics 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.

Otc - Active Ingredient



Active ingredients:

Avobenzone 2.5%

Octinoxate 7.5%

Oxybenzone 6%

Titanium dioxide 2%


Otc - Purpose



Purpose: Sunscreen

Otc - Keep Out Of Reach Of Children



Keep out of reach of children.

Indications & Usage



This oil and fragrance-free broad spectrum UVA/UVB sunscreen provides important protection against the sun’s harmful rays. Recommended for use on face and body, for everyday wear and outdoor activities. This cosmetically elegant formula is non-greasy, leaves a matte finish, and can be reapplied over makeup.

• fragrance-free • oil-free
• for face and body

Uses

■ Helps prevent sunburn.

■ Higher SPF gives more sunburn protection.

■ Provides high protection against sunburn.


Warnings



Warnings

For external use only.

When using this product, keep out of eyes. If contact occurs, rinse abundantly with water to remove.

Stop use and ask a doctor if rash or irritation develops and lasts.

If swallowed, seek medical assistance or contact a Poison Control Center immediately.


Other information

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

Store at room temperature 15-30°C (59-86°F).


Dosage & Administration



Directions

■ Apply liberally and evenly to face and exposed areas 15-30 minutes before sun exposure.

■ Reapply every two hours or as needed.

■ Reapply after swimming, towel drying, washing or perspiring heavily.

■ Children under 6 months of age: ask a doctor.


Inactive Ingredient



Inactive ingredients: water, octyldodecyl neopentanoate, propylene glycol, acer saccharum, tocopheryl acetate, cetyl alcohol, stearic acid, DEA-cetyl phosphate, panthenol, dimethicone, xanthan gum, carbomer, sodium hydroxide, phenoxyethanol, chlorphenesin, BHT, iron oxides (CI 77491).

Package Label.Principal Display Panel



SUN DEFENSE SPF 30

120 mL / 4 fl. oz

DIN 02241810

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Sun Defense SPF front panel image - sundefense SPF thirty

Sun Defense SPF front panel image - sundefense SPF thirty



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