Sunbar SPF 48 description, usages, side effects, indications, overdosage, supplying and lots more!

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Sunbar SPF 48

Kamins Dermatologics Inc.
Kamins Dermatologics Inc.

SUNBAR SPF48 CONSUMER LABELING




FULL PRESCRIBING INFORMATION

Active ingredient


Ensulizole 3%

Homosalate 10%

Octinoxate 7.5%

Octocrylene 7%

Zinc oxide 8%

Purpose



Uses

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

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

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




■ 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.

lycerin, cyclohexasiloxane, clactic acid, s, to





Sunbar SPF 48

Sunbar SPF 48

Ensulizole Homosalate Octinoxate Octocrylene Zinc oxide CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63550-809
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Ensulizole Ensulizole 30 mg
HOMOSALATE Homosalate 100 mg
OCTINOXATE OCTINOXATE 75 mg
OCTOCRYLENE Octocrylene 70 mg
Zinc Oxide Zinc oxide 80 mg

Inactive Ingredients

Ingredient Name Strength
water
CYCLOMETHICONE 5
DIMETHICONE
ACER SACCHARUM SAP
GLYCERIN
CYCLOMETHICONE 6
CETOSTEARYL ALCOHOL
STEARETH-100
C13-14 ISOPARAFFIN
LAURETH-7
STEARETH-2
LACTIC ACID
SODIUM HYDROXIDE
.ALPHA.-TOCOPHEROL ACETATE, D-
XANTHAN GUM
PHENOXYETHANOL
CHLORPHENESIN

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:63550-809-10 120 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2010-09-29


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