PIXI SUN MIST SPF 30- amiloxate, octinoxate, octisalate, titanium dioxide spray

PIXI SUN MIST SPF 30 by

Drug Labeling and Warnings

PIXI SUN MIST SPF 30 by is a Otc medication manufactured, distributed, or labeled by PIXI, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

AMILOXATE (3%)

OCTINOXATE (7%)

OCTISALATE (3%)

TITANIUM DIOXIDE (1.9%)

PURPOSE

SUNSCREEN

USES

• HELPS PREVENT SUNBURN.
• IF USED AS DIRECTED WITH OTHER SUN PROTECTION MEASURES (SEE DIRECTIONS), DECREASES THE RISK OF SKIN CANCER AND EARLY SKIN AGIN CAUSED BY THE SUN.

WARNINGS

FOR EXTERNAL USE ONLY.

DO NOT USE ON DAMAGED OR BROKEN SKIN.

WHEN USING THIS PRODUCT KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.

STOP USE AND ASK A DOCTOR IF SKIN RASH OCCURS.

KEEP OUT OF REACH OF CHILDREN.

IF PRODUCT IS SWALLOWED, GET MEIDCAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

• SHAKE WELL BEFORE USE.
• APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE.
• REAPPLY: 
•    AFTER 40 MINUTES OF SWIMMING OR SWEATING 
•    IMMEDIATELY AFTER TOWEL DRYING 
•    AT LEAST EVERY 2 HOURS.
• SUN PROTECTION MEASURES. SPENDING TIME IN THE SUN INCREASES YOUR RISK OF SKIN CANCER AND EARLY SKIN AGING. TO DECREASE THIS RISK, REGULARLY USE A SUNSCREEN WITH A BROAD SPECTRUM SPF OF 15 OR HIGHER AND OTHER SUN PROTECTION MEASURES INCLUDING:
•    LIMIT TIME IN THE SUN, ESPECIALLY FROM 10 AM - 2 PM
•    WEAR LONG-SLEEVE SHIRTS, PANTS, HATS, AND SUNGLASSES
• CHILDREN UNDER 6 MONTHS. ASK A DOCTOR.

INACTIVE INGREDIENTS

DISILOXANE, WATER/AQUA/EAU, ALCOHOL, CYCLOPENTASILOXANE, C12-15 ALKYL BENZOATE, DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE, CETYL PEG/PPG-10/1 DIMETHICONE, BUTYLENE GLYCOL, DICAPRYLYL CARBONATE, PHENOXYETHANOL, STEARIC ACID, SODIUM CHLORIDE, ALUMINUM HYDROXIDE, POLYHYDROXYSTEARIC ACID, ALUMINUM STEARATE, DIPROPYLENE GLYCOL, DISODIUM EDTA, JASMINUM OFFICINALE (JASMINE) OIL, ALOE BARBADENSIS LEAF EXTRACT, PORTULACA OLERACEA EXTRACT, ANTHEMIS NOBILIS FLOWER EXTRACT, BAMBUSA VULGARIS EXTRACT, TOCOPHEROL. MADE IN KOREA.

OTHER INFORMATION

PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN.

QUESTIONS OR COMMENTS?

CALL TOLL FREE 1-800-792-5330

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PIXI SUN MIST SPF 30 
amiloxate, octinoxate, octisalate, titanium dioxide spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70686-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AMILOXATE (UNII: 376KTP06K8) (AMILOXATE - UNII:376KTP06K8)	AMILOXATE	3 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	3 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.9 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
HEXAMETHYLDISILOXANE (UNII: D7M4659BPU)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
EDETATE DISODIUM (UNII: 7FLD91C86K)
JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PURSLANE (UNII: M6S840WXG5)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
BAMBUSA VULGARIS TOP (UNII: FIW80T6P6V)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70686-101-13	80 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	08/03/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/03/2016

Labeler - PIXI, INC (830752593)

Registrant - PIXI, INC (830752593)