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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ACTIVE INGREDIENTS

AMILOXATE (3%)

OCTINOXATE (7%)

OCTISALATE (3%)

TITANIUM DIOXIDE (1.9%)

PURPOSE

SUNSCREEN

USES

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

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

Sun Mist-Pack-12JUL16-outline.jpg

PIXI SUN MIST SPF 30 
amiloxate, octinoxate, octisalate, titanium dioxide spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70686-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMILOXATE (UNII: 376KTP06K8) (AMILOXATE - UNII:376KTP06K8) AMILOXATE3 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE3 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.9 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70686-101-1380 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/03/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/03/2016
Labeler - PIXI, INC (830752593)
Registrant - PIXI, INC (830752593)

Revised: 11/2018
Document Id: fc9615cf-17f0-47dd-b79b-f32206b8708a
Set id: 49001a18-ae05-493e-92da-95b56401b323
Version: 2
Effective Time: 20181108
 
PIXI, INC