SUNBAR SPF 15

Dosage form: spray
Ingredients: AVOBENZONE 30mg in 1mL, HOMOSALATE 100mg in 1mL, OCTISALATE 50mg in 1mL, OXYBENZONE 60mg in 1mL
Labeler: Kamins Dermatologics Inc.
NDC Code: 63550-810

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.

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 02312484

SUNBAR SPF 15 
avobenzone homosalate octisalate oxybenzone spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63550-810
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (AVOBENZONE) AVOBENZONE30 mg  in 1 mL
HOMOSALATE (HOMOSALATE) HOMOSALATE100 mg  in 1 mL
OCTISALATE (OCTISALATE) OCTISALATE50 mg  in 1 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE60 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
MALIC ACID 
DIETHYLHEXYL 2,6-NAPHTHALATE 
PPG-5-CETETH-20 
ETHYLENE BRASSYLATE 
.ALPHA.-TOCOPHEROL ACETATE, D- 
ACER SACCHARUM SAP 
POMEGRANATE 
PROPYLENE GLYCOL 
WATER 
ACAI 
VITAMIN A PALMITATE 
MAGNESIUM ASCORBYL PHOSPHATE 
ALCOHOL 
Packaging
#Item CodePackage Description
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/FEIOperations
Kamins Dermatologics Inc.254050784manufacture, pack, label

Revised: 09/2010
 
Kamins Dermatologics Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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