SUNBAR SPF 48 - ensulizole homosalate octinoxate octocrylene zinc oxide cream 
Kamins Dermatologics Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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SUNBAR SPF48 CONSUMER LABELING

Active ingredients:

Ensulizole 3%

Homosalate 10%

Octinoxate 7.5%

Octocrylene 7%

Zinc oxide 8%

Purpose: Sunscreen

Keep out of children’s reach.

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

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).


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 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.

B. KAMINS

SUNBAR SPF48


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

SUNBAR SPF 48 
ensulizole homosalate octinoxate octocrylene zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63550-809
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE70 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE80 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63550-809-10120 mL in 1 BOX
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35209/29/2010
Labeler - Kamins Dermatologics Inc. (254050784)
Registrant - Kamins Dermatologics Inc. (254050784)
Establishment
NameAddressID/FEIBusiness Operations
Kamins Dermatologics Inc.254050784manufacture, pack, label

Revised: 9/2010
Document Id: 30b4cbbf-d534-4fca-9e49-05738ba8e688
Set id: 9ab925b3-f04e-4f7d-a2d0-b70aece8564b
Version: 1
Effective Time: 20100929
 
Kamins Dermatologics Inc.