SUN DEFENSE UVSCREEN SPF 48- ensulizole homosalate octinoxate octocrylene zinc oxide cream

Sun Defense UVscreen SPF 48 by

Drug Labeling and Warnings

Sun Defense UVscreen SPF 48 by is a Otc medication manufactured, distributed, or labeled by Kamins Dermatologics Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients:

Ensulizole 3%

Homosalate 10%

Octinoxate 7.5%

Octocrylene 7%

Zinc oxide 8%

PURPOSE

Purpose: Sunscreen

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

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.

PRINCIPAL DISPLAY PANEL

SUN DEFENSE UVscreen SPF 48

120 mL / 4 fl. oz

DIN 02280329

image/jpg

INGREDIENTS AND APPEARANCE

SUN DEFENSE UVSCREEN SPF 48 
ensulizole homosalate octinoxate octocrylene zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63550-852
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	70 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	80 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
ACER SACCHARUM SAP (UNII: 75UOH57984)
GLYCERIN (UNII: PDC6A3C0OX)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
STEARETH-100 (UNII: 4OH5W9UM87)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LAURETH-7 (UNII: Z95S6G8201)
STEARETH-2 (UNII: V56DFE46J5)
LACTIC ACID (UNII: 33X04XA5AT)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
XANTHAN GUM (UNII: TTV12P4NEE)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63550-852-10	120 mL in 1 BOX

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	09/02/2011

Labeler - Kamins Dermatologics Inc. (254050784)

Registrant - Kamins Dermatologics Inc. (254050784)

Establishment
Name	Address	ID/FEI	Business Operations
Kamins Dermatologics Inc.		254050784	manufacture, pack, label