Shiseido Waso Shikulime Color Control Cream
FDA Label NDC 58411-965

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Shiseido Americas Corporation for the product Shiseido Waso Shikulime Color Control (NDC 58411-965). 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 other, otc - purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Otc - Purpose

 Active Ingredients Purpose
 AVOBENZONE 2.3% Sunscreen
 HOMOSALATE 10% Sunscreen
 OCTISALATE 5.0% Sunscreen
 OCTOCRYLENE 5.0% 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 aging caused by the sun

Warnings

For external use only

Otc - Do Not Use

Do not useon damaged or broken skin

Otc - When Using

When using this productkeep out of eyes. Rinse with water to remove.

Otc - Stop Use

Stop use and ask a doctorif rash occurs

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Co

Directions

For suncreen use:

  • apply liberally 15 minutes before sun exposure
  • use a water resistant sun screen if swimming or sweating
  • reapply 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 a.m. - 2p.m.        

             -wear long-sleeve shirts, pant, hats, and sunglasses 

    • children under 6 months: Ask a doctor

Inactive Ingredients

WATER･BUTYLENE GLYCOL･CAPRYLYL METHICONE･SILICA･GLYCERIN･SD ALCOHOL 40-B･CETYL PEG/PPG-10/1 DIMETHICONE･DIPROPYLENE GLYCOL･ZEA MAYS (CORN) STARCH･POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER･ERYTHRITOL･C30-45 ALKYL METHICONE･PEG-150･TREHALOSE･SODIUM CHLORIDE･PYRUS MALUS (APPLE) FRUIT WATER･CITRUS DEPRESSA PEEL EXTRACT･C30-45 OLEFIN･CELLULOSE GUM･TRISODIUM EDTA･BIS-BUTYLDIMETHICONE POLYGLYCERYL-3･POLYESTER-1･SILICA DIMETHYL SILYLATE･ALUMINUM HYDROXIDE･ALCOHOL･POLYSILICONE-2･SODIUM METABISULFITE･PHENOXYETHANOL･TITANIUM DIOXIDE･IRON OXIDES･MICA･

Other Information

  • protect this product in this container fro excessive heat and direct sun.
  • cap contains natural materials that may change color/texture over time. This doesn't affect product quality. Wipe any liquid or dirt off the cap and store in a dry area.

Questions Or Comments?

Call toll free-1-800-906-7503

Principle Display Panel- 50 Ml

WASO

SHISEIDO

GINZA TOKYO

SHIKULIME

COLOR CONTROL

OIL-FREE MOISTURIZER

BROAD SPECTRUM

SPF 30

SUNSCREEN

BARRIER BALANCE

50mL NET WT. 1.8 OZ.

* Please review the disclaimer below.