Label: PIXI SUN MIST SPF 30- amiloxate, octinoxate, octisalate, titanium dioxide spray
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Contains inactivated NDC Code(s)
NDC Code(s): 70686-101-13 - Packager: PIXI, INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated November 8, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
- PURPOSE
- USES
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN.
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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.
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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
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PIXI SUN MIST SPF 30
amiloxate, octinoxate, octisalate, titanium dioxide sprayProduct 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)
