Label: SUNZONE BABY SUNSCREEN SPF-60 BROAD SPECTRUM- avobenzone and octinoxate lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 50021-241-01 - 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 November 13, 2012
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Active Ingredients
Avobenzone......3%
Octinoxate........4%
Purpose
Sunscreen
Uses
Helps prevent sunburn
Warnings
For external use only
When using the product do not get into eyes. If contact occurs, rinse thoroughly with water
Stop use and ask a doctor if irritaion occurs
Keep out of reach of children If product is swallowed, get medical help or contact a Posion Control Center right away
Directions - Apply liberally and spread evenly 15 minutes before sun exposure
- Reapply after 80 minutes of swimmin or sweating
- immediately after swimming, towel drying
- At least every 2 hours
SUN PROTECTION MEASURES. Spending time in the sun increases your risk of skin cancer and early skin damage. To decrease this risk, regularly use a sunscreen with broad spectrum SPF 15 or higher and other sun protection measures including;
- Limit time in the sun, especially from 10 a.m-2p.m
- 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, dl-alpha Tocopheryl acetate, Ethylhexylglycerin, fragrance, glycerin, Octyldodecyl Citrate Crosspolymer, Phenoxyethanol, Phenyl Trimethicone, Water
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SUNZONE BABY SUNSCREEN SPF-60 BROAD SPECTRUM
avobenzone and octinoxate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50021-241 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 9.36 g in 234 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 7.02 g in 234 g Inactive Ingredients Ingredient Name Strength CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) TRIOCTYLDODECYL CITRATE (UNII: 35X8CT063R) WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60) GLYCERIN (UNII: PDC6A3C0OX) C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ) 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:50021-241-01 234 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/13/2012 Labeler - Empack Spraytech Inc. (252047519) Registrant - Empack Spraytech Inc. (252047519) Establishment Name Address ID/FEI Business Operations Empack Spraytech Inc. 252047519 manufacture(50021-241)
