PEACH SAKE SUN SPF32 PA PLUS PLUS- octinoxate lotion

PEACH SAKE SUN by

Drug Labeling and Warnings

PEACH SAKE 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%, TITANIUM DIOXIDE 3.3%

INACTIVE INGREDIENT

Inactive ingredients:

WATER, ISOAMYL p-METHOXYCINNAMATE, PROPYLENE GLYCOL, BUTYLENE GLYCOL, POLYSORBATE 80, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE, BIS-PEG-18 METHYL ETHER DIMETHYL SILANE, DIETHYLHEXYL CARBONATE, POLYGLYCERYL-6 POLYHYDROXYSTEARATE, RIMETHOXYCAPRYLYLSILANE, SORBITAN LAURATE, ALUMINUM HYDROXIDE, STEARIC ACID, POTASSIUM CETYL PHOSPHATE, SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, ISOHEXADECANE, DIMETHICONE, PRUNUS PERSICA (PEACH) FRUIT EXTRACT, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, CENTELLA ASIATICA EXTRACT, GLYCINE SOJA (SOYBEAN) SEED EXTRACT, PYRUS MALUS (APPLE) FRUIT EXTRACT, CARBOMER, BHT, TOCOPHERYL ACETATE, CAMELLIA SINENSIS LEAF EXTRACT, TRIETHANOLAMINE, DISODIUM EDTA, RICE FERMENT FILTRATE (SAKE), PHENOXYETHANOL, METHYLPARABEN, PROPYLPARABEN, FRAGRANCE

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

PEACH SAKE SUN  SPF32 PA PLUS PLUS
octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76214-012
Route of Administration	CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	5.25 mL  in 75 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE)	TITANIUM DIOXIDE	2.47 mL  in 75 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
DIETHYLHEXYL CARBONATE (UNII: YCD50O0Z6L)
TRIMETHOXYCAPRYLYLSILANE (UNII: FZ07E4LW2M)
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
ISOHEXADECANE (UNII: 918X1OUF1E)
DIMETHICONE (UNII: 92RU3N3Y1O)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
PEACH (UNII: 3OKE88I3QG)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
CHAMOMILE (UNII: FGL3685T2X)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
SOYBEAN (UNII: L7HT8F1ZOD)
APPLE (UNII: B423VGH5S9)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
TROLAMINE (UNII: 9O3K93S3TK)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76214-012-01	75 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