ALOE SUN ESSENCE SPF 27 PA PLUS PLUS- octinoxate cream

ALOE SUN ESSENCE by

Drug Labeling and Warnings

ALOE SUN ESSENCE 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 2.48%

INACTIVE INGREDIENT

Inactive ingredients:
WATER, ISOAMYL p-METHOXYCINNAMATE, BUTYLENE GLYCOL, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, CYCLOPENTASILOXANE, GLYCERIN, ISONONYL ISONONANOATE, MYRISTYL ALCOHOL, POLYSORBATE 80, CETYL ALCOHOL, STEARIC ACID, POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE, STEARETH-21, ALOE BARBADENSIS LEAF EXTRACT, BETA-GLUCAN, DIMETHICONE, PORTULACA OLERACEA EXTRACT, SORBITAN STEARATE, SODIUM POLYACRYLATE, POTASSIUM CETYL PHOSPHATE, ALUMINUM HYDROXIDE, 1,2-HEXANEDIOL, C13-14 ISOPARAFFIN, POLYACRYLAMIDE, LAURETH-7, CAMELLIA SINENSIS LEAF EXTRACT, ETHYLHEXYL STEARATE, BHT, TOCOPHERYL ACETATE, TRIDECETH-6, SODIUM HYALURONATE, DISODIUM EDTA, PHENOXYETHANOL, METHYLPARABEN, BUTYLPARABEN, 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

ALOE SUN ESSENCE  SPF 27 PA PLUS PLUS
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76214-030
Route of Administration	CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.5 mL  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE)	TITANIUM DIOXIDE	1.24 mL  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
GLYCERIN (UNII: PDC6A3C0OX)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
MYRISTYL ALCOHOL (UNII: V42034O9PU)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
CETYL ALCOHOL (UNII: 936JST6JCN)
STEARIC ACID (UNII: 4ELV7Z65AP)
STEARETH-21 (UNII: 53J3F32P58)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DIMETHICONE (UNII: 92RU3N3Y1O)
PURSLANE (UNII: M6S840WXG5)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
METHYLPARABEN (UNII: A2I8C7HI9T)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LAURETH-7 (UNII: Z95S6G8201)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76214-030-01	50 mL in 1 CARTON

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