ALOE SUN SPF28 PA PLUS PLUS- octinoxate spray

ALOE SUN by

Drug Labeling and Warnings

ALOE 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%, ENSULIZOLE 2%

INACTIVE INGREDIENT

Inactive ingredients:
WATER, C12-15 ALKYL BENZOATE, 4-METHYLBENZYLIDENE CAMPHOR, BUTYLENE GLYCOL, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, CAPRYLIC/CAPRIC TRIGLYCERIDE, CETEARETH-6 OLIVATE, PEG-7 GLYCERYL COCOATE, ALOE BARBADENSIS LEAF EXTRACT, C12-20 ALKYL GLUCOSIDE, C14-22 ALCOHOLS, DIMETHICONE, MALPIGHIA GLABRA(ACEROLA) FRUIT EXTRACT, GLYCERIN, SODIUM HYDROXIDE, CELLULOSE GUM, CETEARYL OLIVATE, SORBITAN OLIVATE, MICROCRYSTALLINE CELLULOSE, DISODIUM EDTA, ETHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, 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

ALOE SUN  SPF28 PA PLUS PLUS
octinoxate spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76214-019
Route of Administration	CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7 mL  in 100 mL
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	2 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ENZACAMENE (UNII: 8I3XWY40L9)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BEMOTRIZINOL (UNII: PWZ1720CBH)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)
C14-22 ALCOHOLS (UNII: B1K89384RJ)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
SORBITAN OLIVATE (UNII: MDL271E3GR)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
EDETATE DISODIUM (UNII: 7FLD91C86K)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76214-019-01	100 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