Label: SUNZONE KIDS SPF 45 BROAD SPECTRUM- octocrylene, octisalate, homosalate, avobenzone and oxybenzone aerosol, spray
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Contains inactivated NDC Code(s)
NDC Code(s): 50021-151-01 - Packager: Empack Spraytech Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 December 17, 2012
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Active Ingredients
Avobenzone....2.0%
Homosalate.....10%
Octisalate........5.0%
Octocrylene.....2.0%
Oxybenzone....5.0%
Purpose
Sunscreen
Uses
Helps prevent sunburn
if used as directed with other sun protection measures (see direction), decrease the risk of skin cancer and early skin aging by the sun
Warnings
For external use only
Flammable: Do not use near heat, flame or while smoking
Do not use on damaged or broken skin
When using this product keep away from face to avoid breathing it.
Do not punture or incinerate. Contents under pressure
Do not store at temperatures above 120 F
Stop use and ask a doctor if rash occurs
keep out of reach of children
If product is swallowed, get medical help or contact a Posion Control Center right away
Directions Inactive Ingredients Acrylates Copolymer, Alcohol Denat., Aloe Barbadensis Leaf Extract, Bisabolol,
Bis-Hydroxyethoxypropyl Dimethicone, Camellia Oleifera (Japanese Green Tea) Leaf Extract,
Ethylhexylglycerin, Diethylhexyl 2,6-Naphthalate, Fragrance, Phenoxyethanol, Tocopherol Acetate (Vitamin E)
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SUNZONE KIDS SPF 45 BROAD SPECTRUM
octocrylene, octisalate, homosalate, avobenzone and oxybenzone aerosol, sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50021-151 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 3.0 g in 150 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 7.5 g in 150 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 15.0 g in 150 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3.0 g in 150 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 7.5 g in 150 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) BIS-HYDROXYETHOXYPROPYL DIMETHICONE (50 CST) (UNII: YP714N2H05) DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60) .BETA.-BISABOLOL (UNII: LP618AV2EA) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ALOE VERA LEAF (UNII: ZY81Z83H0X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50021-151-01 150 g in 1 CAN Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/19/2012 Labeler - Empack Spraytech Inc (252047519) Registrant - Empack Spraytech Inc (252047519) Establishment Name Address ID/FEI Business Operations Empack Spraytech Inc 252047519 manufacture(50021-151)
