Label: SUNZONE SUNSCREEN SPORT SPF 15 BROAD SPECTRUM- octinoxate and avobenzone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 50021-304-01 - 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
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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Active Ingredient
Avobenzone........0.50%
Octinoxate..........1.0%
Purpose
Sunscreen
Uses
Helps prevent sunburn
Warnings
For external use only
When using this product do not get into eyes. If contact occurs, rinse thoroughly with water
Stop use and ask a doctor if irritaion or rash occurs
Keep out of reach of children If product is swallowed, get medical help or contact a Posion Contro Center right away
Directions - Apply liberally and spread envenly 15 minutes before sun exposure
- Reapply after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
- Use in a well-ventilated area
Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging.
to decrease this risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun
prtection measures including:
- Limit time in the sun, especially from 10 am - 2 pm
- Wear long-sleeve shirts, pants, hats and sunglasses
- Children under 6 Months: ASK A DOCTOR
Inactive Ingredients Acrylates Copolymer, Aloe Barbadensis Leaf Extract, Aminomethyl Propanol, Ammonium Acryloyldimethyltaurate/VP Copolymer, C12-15 Alkyl Benzoate, Camellia Oleifera (Japanese Green Tea) Leaf Extract, Carthamus Tinctorius (safflower) Oleosomes, Ethylhexylglycerin, Fragrance, Glycerin, Phenoxyethanol, Phenyl Trimethicone, Tocopheryl acetate(Vitamin E), Water
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SUNZONE SUNSCREEN SPORT SPF 15 BROAD SPECTRUM
octinoxate and avobenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50021-304 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.35 g in 235 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.18 g in 235 g Inactive Ingredients Ingredient Name Strength CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ) WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60) GLYCERIN (UNII: PDC6A3C0OX) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50021-304-01 235 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 12/17/2012 Labeler - Empack Spraytech Inc. (252047519) Registrant - Empack Spraytech Inc. (252047519) Establishment Name Address ID/FEI Business Operations Empack Spraytech Inc. 252047519 manufacture(50021-304)
