SUNBAR SPF 15 - avobenzone homosalate octisalate oxybenzone spray 
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 SPRAY SPF15 CONSUMER LABELING

Active ingredients:

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Oxybenzone 6%

Purpose: Sunscreen

Keep out of children’s reach.

A broad spectrum UVA/UVB sunscreen to help protect the skin from sunburn. Sunbar Spray SPF 15 is enriched with moisturizing açai oil, pomegranate extract and Bio-MapleTM compound to help skin remain hydrated.

Uses

■ Helps prevent sunburn.

■ Higher SPF gives more sunburn protection.

■ Provides high protection against sunburn.

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.

Flammable: Keep away from open flame or source of heat.  Do not use while smoking. Avoid long term storage above 40 °C (104°F)


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.



Directions

■ Apply 15-30 minutes before sun exposure.

■ Hold bottle 8-10 inches from the skin and press pump to spray a fine even mist.

■ Spray liberally and evenly over all exposed areas to ensure complete coverage.

■ Do not spray directly onto face; spray into hands, then immediately apply to face.

■ Rub into skin on all exposed areas.

■ Reapply every two hours or as needed, after swimming, washing, towel drying, or perspiring heavily.

Inactive ingredients: alcohol denat., ethyl macadamiate, tocopherol, malic acid, diethylhexyl 2,6-naphthalate, PPG-5-ceteth-20, acrylates/octylacrylamide copolymer, ethylene brassylate, lauryl PCA, tocopheryl acetate, acer saccharum (maple isolate), punica granatum (pomegranate) extract, propylene glycol, water, euterpe oleracea (acai) oil, retinyl palmitate, magnesium ascorbyl phosphate.

B. KAMINS

SUNBAR SPRAY SPF15

150mL / 5 fl.oz

DIN 02312484Sunbar Spray SPF front panel image

SUNBAR SPF 15 
avobenzone homosalate octisalate oxybenzone spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63550-810
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE60 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
MALIC ACID (UNII: 817L1N4CKP)  
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)  
PPG-5-CETETH-20 (UNII: 4AAN25P8P4)  
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
ACER SACCHARUM SAP (UNII: 75UOH57984)  
POMEGRANATE (UNII: 56687D1Z4D)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
ACAI (UNII: 46AM2VJ0AW)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63550-810-12150 mL in 1 BOX
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35209/30/2010
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: e20e5f13-95b4-4bfc-9b95-44533d0c533f
Set id: 38053dac-a26a-41a4-8bbb-7bc094c99d93
Version: 1
Effective Time: 20100930
 
Kamins Dermatologics Inc.