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  5. Label Information: Sunbar Spf 48

FDA Label for Sunbar Spf 48

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

Sunbar Spf 48 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:

Ensulizole 3%

Homosalate 10%

Octinoxate 7.5%

Octocrylene 7%

Zinc oxide 8%


Otc - Purpose



Purpose: Sunscreen

Otc - Keep Out Of Reach Of Children



Keep out of children’s reach.

Indications & Usage



A hydrating, broad spectrum UVA/UVB sunscreen, which provides protection against sunburn. Combines our moisturizing Bio-MapleTM compound with a mixture of sunscreens that protect skin by scattering, reflecting and absorbing harmful sun rays. Fragrance, color and oil-free, ideal for those with sensitive skin.

Uses

■ Helps prevent sunburn.

■ Higher SPF gives more sunburn protection.

■ Provides high protection against sunburn.


Warnings



Warnings

For external use only.

Avoid contact with eyes when using this product. If contact occurs, rinse abundantly with water to remove.

Discontinue use in case of excessive skin irritation or if condition does not improve. If irritation persists, consult a health care practitioner.

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.

■ Consult a doctor before using on children under six months of age.


Inactive Ingredient



Inactive ingredients: water, cyclopentasiloxane, dimethiconol, acer saccharum (maple isolate), glycerin, cyclohexasiloxane, cetearyl alcohol, steareth-100, polyacrylamide, C13-14 isoparaffin, laureth-7, steareth-2, dimethicone, VP/eicosene copolymer, lactic acid, sodium hydroxide, dimethoxydiphenylsilane/triethoxycaprylylsilane crosspolymer, tocopheryl acetate, xanthan gum, phenoxyethanol, chlorphenesin.

Package Label.Principal Display Panel



B. KAMINS

SUNBAR SPF48


120 mL / 4 fl. oz
DIN 02280329
Sunbar SPF front panel image - Sunbar SPF front panel

Sunbar SPF front panel image - Sunbar SPF front panel


* Please review the disclaimer below.