CACTUS WHITENING SUN SPF 34 PA PLUS PLUS FOR MEN- octinoxate lotion

CACTUS WHITENING SUN by

Drug Labeling and Warnings

CACTUS WHITENING SUN by is a Otc medication manufactured, distributed, or labeled by SKINFOOD CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients: OCTINOXATE 7%, OCTISALATE 5%, TITANIUM DIOXIDE 0.93%

INACTIVE INGREDIENT

Inactive ingredients:
WATER, ISOAMYL p-METHOXYCINNAMATE, BUTYLENE GLYCOL, PROPYLENE GLYCOL, ARBUTIN, CETEARETH-6 OLIVATE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, C14-22 ALCOHOLS, CYCLOPENTASILOXANE, POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE, SORBITAN STEARATE, C12-20 ALKYL GLUCOSIDE, SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT, ALOE BARBADENSIS LEAF EXTRACT, CEREUS GRANDIFLORUS (CACTUS) FLOWER EXTRACT, ISOHEXADECANE, AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER, POLYSORBATE 80, POTASSIUM CETYL PHOSPHATE, ALUMINUM HYDROXIDE, STEARIC ACID, BHT, TOCOPHERYL ACETATE, DISODIUM EDTA, METHYLPARABEN, PROPYLPARABEN, PHENOXYETHANOL, FRAGRANCE, SILICA

PURPOSE

Purpose: Protects skin from UV rays.

WARNINGS

Warnings:
For external use only.
Avoid contact with eyes.
Discontinue use if signs of irritation appear.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children:
Keep out of reach of children.

INDICATIONS & USAGE

Indication and usage:
Use at the end of your daily skincare regimen.
Apply liberally onto face and body before sun exposure avoiding the eye area.

DOSAGE & ADMINISTRATION

Dosage and administration:
For best results, apply at least 15 to 20 minutes before sun exposure.
Reapply frequently while out in the sun.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CACTUS WHITENING SUN  SPF 34 PA PLUS PLUS FOR MEN
octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76214-032
Route of Administration	CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	4.9 mL  in 70 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	3.5 mL  in 70 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE)	TITANIUM DIOXIDE	0.65 mL  in 70 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ARBUTIN (UNII: C5INA23HXF)
C14-22 ALCOHOLS (UNII: B1K89384RJ)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CUCUMBER (UNII: YY7C30VXJT)
METHYLPARABEN (UNII: A2I8C7HI9T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ISOHEXADECANE (UNII: 918X1OUF1E)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76214-032-01	70 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/01/2011

Labeler - SKINFOOD CO., LTD. (690324173)

Registrant - SKINFOOD CO., LTD. (690324173)

Establishment
Name	Address	ID/FEI	Business Operations
SKINFOOD CO., LTD.		690324173	manufacture