CHARMZONE ALBATROSS POWDER SUN (SPF41 PA) - octinoxate octisalate zinc oxide titanium dioxide cream 
CHARMZONE CO LTD

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.

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Label1

WARNINGS:

For external use only.  Avoid contact with eyes.  Keep out of children's reach.




Label2

INGREDIENTS:

WATER, ETHYLHEXYL METHOXYCINNAMATE, BUTYLENE GLYCOL, POLYMETHYL METHACRYLATE, ETHYLHEXYL DIMETHYL PABA, ETHYLHEXYL SALICYLATE, HYDROGENATED POLYDECENE, ZINC OXIDE, SILICA, CYCLOMETHICONE, BUTYL METHOXYDIBENZOYLMETHANE, BIOSACCHARIDE GUM-1, TITANIUM DIOXIDE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, CETYL ALCOHOL, CETEARETH-12, GLYCERYL STEARATE, PEG-100 STEARATE, SODIUM HYALURONATE, STEARIC ACID, DIETHOXYETHYL SUCCINATE, GLYCERYL POLYACRYLATE, SORBITAN OLIVATE, BEESWAX, CETEARYL OLIVATE, CETYL PALMITATE, AMMONIUM ACRYLOYLDIMETHYLTAURATE / VP COPOLYMER, PHENOXYETHANOL, SORBITAN PALMITATE, TOCOPHERYL ACETATE, POTASSIUM CETYL PHOSPHATE, METHYLPARABEN, TRIETHOXYCAPRYLYLSILANE, FRAGRANCE, BIFIDA FERMENT LYSATE, BUTYLPARABEN, DIPOTASSIUM GLYCYRRHIZATE, HYDROLYZED SOY PROTEIN, MORUS ALBA ROOT EXTRACT, PEG-1182 METHYL ESTER SERICIN, PROPYLPARABEN, XANTHAN GUM, MAGNESIUM ASCORBYL PHOSPHATE, BHT, DIMETHICON, FOMES OFFICINALIS (MUSHROOM) EXTRACT, DISODIUM EDTA, STEARYL GLYCYRRHETINATE, GLYCOSAMINOGLYCANS, ATELOCOLLAGEN, BAMBUSA  ARUNDINACEA STEM EXTRACT, RUBUS SUAVISSIMUS (RASPBERRY) LEAF EXTRACT, PORTULACA OLEACEA EXTRACT, ANGELICA POLYMORPHA SINENSIS ROOT EXTRACT, ASPALATHUS LINEARIS LEAF EXTRACT, VISCUM ALBUM (MISTLETOE) LEAF EXTRACT


Label3

[How to Use]

1) Before outdoor leisure activities, evenly smooth over face (avoid around the eyes), arms, neck, legs and other areas that might be exposed to sunlight.

2) It can be used as under-makeup and helps the color makeup adhere to skin and stay on.


Label4



LABEL

CHARMZONE ALBATROSS POWDER SUN (SPF41 PA) 
octinoxate octisalate zinc oxide titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:22201-2001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4.91 mL  in 70 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE3.15 mL  in 70 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC - UNII:J41CSQ7QDS) ZINC OXIDE2.33 mL  in 70 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE) TITANIUM DIOXIDE1.225 mL  in 70 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22201-2001-170 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35212/01/2009
Labeler - CHARMZONE CO LTD (689049765)
Registrant - CHARMZONE CO LTD (689049765)
Establishment
NameAddressID/FEIBusiness Operations
CHARMZONE CO LTD689049765manufacture

Revised: 11/2009
Document Id: 5d7f20ed-e64b-4c80-8695-e27eeaa0c533
Set id: 7716c299-e286-4a19-83ad-fac91a908b47
Version: 1
Effective Time: 20091109
 
CHARMZONE CO LTD