Label: SUNBAR SPF 15- avobenzone homosalate octisalate oxybenzone spray
-
Contains inactivated NDC Code(s)
NDC Code(s): 63550-810-12 - Packager: Kamins Dermatologics Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated September 30, 2010
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
-
INDICATIONS & USAGE
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
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.
-
DOSAGE & ADMINISTRATION
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 INGREDIENT
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.
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SUNBAR SPF 15
avobenzone homosalate octisalate oxybenzone sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63550-810 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 100 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 60 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:63550-810-12 150 mL in 1 BOX Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 09/30/2010 Labeler - Kamins Dermatologics Inc. (254050784) Registrant - Kamins Dermatologics Inc. (254050784) Establishment Name Address ID/FEI Business Operations Kamins Dermatologics Inc. 254050784 manufacture, pack, label
