Label: SUNZONE KIDS SPF 60 BROAD SPECTRUM- octinoxate, octocrylene, octisalate, oxybenzone, avobenzone and homosalate. aerosol, spray
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Contains inactivated NDC Code(s)
NDC Code(s): 50021-061-01 - 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
Octinoxate .......5.0%
Octocrylene...... 5.0%
Octisalate..........5.0%
Oxybenzone..... 6.0%
Avobenzone......3.0%
Homosalate.......12.0%
Uses
- Helps prevent sunburn
- If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early skin aging caused be the sun
When using this product keep away from face to avoid breathing it
Do not puncture or incinerate. Contents under pressure.
Do not store at temperatures above 120 0F
Keep Out of Reach of Children.
If product is swallowed, get medical help or contact a Poison Control Center right away
- Spray liberally and spread evenly by hand 15 minutes before sun exposure
- Reapply
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- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
- Hold container 4 to 6 inches from the skin to apply
- Do not spray directly into face. Spray on hand then apply to face
- Do not apply in windy conditions
- Use in a well-ventilated area
- Sun protection measures. Spending time in the sun increase the risk of skin cancer and early skin again. To decrease this risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including
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- Limit time in the sun, especially from 10 a.m - 2 p.m.
- Wear long-sleeve shirts, pants, hats, and sunglasses.
- Children under 6 months: Ask a doctor
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SUNZONE KIDS SPF 60 BROAD SPECTRUM
octinoxate, octocrylene, octisalate, oxybenzone, avobenzone and homosalate. aerosol, sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50021-061 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.75 g in 155 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 7.75 g in 155 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 7.75 g in 155 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 9.30 g in 155 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 4.65 g in 155 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 18.60 g in 155 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) ALOE VERA LEAF (UNII: ZY81Z83H0X) LEVOMENOL (UNII: 24WE03BX2T) CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) PHENOXYETHANOL (UNII: HIE492ZZ3T) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) BIS-HYDROXYETHOXYPROPYL DIMETHICONE (50 CST) (UNII: YP714N2H05) DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50021-061-01 155 g in 1 CAN Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/16/2012 Labeler - Empack Spraytech Inc. (252047519) Registrant - Empack Spraytech Inc. (252047519) Establishment Name Address ID/FEI Business Operations Empack Spraytech Inc 252047519 manufacture(50021-061)