Pixi Sun Mist Spf 30
FDA Label NDC 70686-101

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pixi, Inc for the product Pixi Sun Mist Spf 30 (NDC 70686-101). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, keep out of reach of children., directions, inactive ingredients, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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?

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