FDA.reportPublic FDA data

PIXI SUN MIST SPF 30

Manufacturer
PIXI, INC
Effective date
2018-11-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:57:12

Label at a glance#

ProductPIXI SUN MIST SPF 30
Active ingredientAMILOXATE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE
Label structure10 sections

Indications and 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.

Dosage and administration

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 MEASUR...

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

AMILOXATE (3%)

OCTINOXATE (7%)

OCTISALATE (3%)

TITANIUM DIOXIDE (1.9%)

PURPOSE

OTC - PURPOSE SECTION

SUNSCREEN

USES

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

OTHER SAFETY INFORMATION

PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN.

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

CALL TOLL FREE 1-800-792-5330

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sun Mist-Pack-12JUL16-outline.jpgSun Mist-Pack-12JUL16-outline.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70686-101-132020-01-31C16284748780-19d75b9d0-e83c-f424-e053-dadaa90a57ce49001a18-ae05-493e-92da-95b56401b323

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70686-101-13PIXI SUN MIST SPF 3080 mL in 1 BOTTLE, SPRAYSPRAY802

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70686-101PIXI SUN MIST SPF 30 (AMILOXATE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE) SPRAY [PIXI, INC]2Legacy NDC, 1 package rows20181109_49001a18-ae05-493e-92da-95b56401b323.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70686-10170686-101-13

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
AMILOXATE376KTP06K8ACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
HEXAMETHYLDISILOXANED7M4659BPUIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
CYCLOMETHICONE 50THT5PCI0RIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATEANQ870JD20IACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5)V2W71V8T0XIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
PHENOXYETHANOLHIE492ZZ3TIACT
STEARIC ACID4ELV7Z65APIACT
SODIUM CHLORIDE451W47IQ8XIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
ALUMINUM STEARATEU6XF9NP8HMIACT
DIPROPYLENE GLYCOLE107L85C40IACT
EDETATE DISODIUM7FLD91C86KIACT
JASMINUM OFFICINALE FLOWER0Q8K841432IACT
ALOE VERA LEAFZY81Z83H0XIACT
PURSLANEM6S840WXG5IACT
CHAMAEMELUM NOBILE FLOWERO2T154T6OGIACT
BAMBUSA VULGARIS TOPFIW80T6P6VIACT
TOCOPHEROLR0ZB2556P8IACT

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
fc9615cf-17f0-47dd-b79b-f32206b8708a49001a18-ae05-493e-92da-95b56401b3232018-11-08WarningsExact identifier
spl id: fc9615cf-17f0-47dd-b79b-f32206b8708a
spl set id: 49001a18-ae05-493e-92da-95b56401b323

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.