SHISEIDO EXTRA SMOOTH SUN PROTECTION N description, usages, side effects, indications, overdosage, supplying and lots more!

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SHISEIDO EXTRA SMOOTH SUN PROTECTION N

SHISEIDO AMERICA INC.

SHISEIDO EXTRA SMOOTH SUN PROTECTION LOTION N


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

ACTIVE INGREDIENTS: Purpose
OCTINOXATE 4.9% Sunscreen
OCTOCRYLENE 3.0% Sunscreen
ZINC OXIDE 12.5% Sunscreen

SHISEIDO EXTRA SMOOTH SUN PROTECTION N 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

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 rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:

  • apply liberally 15 minutes before sun exposure
  • reapply:
    • after 80 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 a.m. – 2 p.m.
    • wear long-sleeve shirts, pants, hats, and sunglasses
  • children under 6 months: Ask a doctor

Inactive Ingredients

DIMETHICONE, WATER, DIPROPYLENE GLYCOL, ETHYLHEXYL PALMITATE, SD ALCOHOL 40-B, PEG-10 DIMETHICONE, TALC, POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER, TRIMETHYLSILOXYSILICATE, XYLITOL, GLYCERIN, PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, METHYL GLUCETH-10, SCUTELLARIA BAICALENSIS ROOT EXTRACT, ECTOIN, ISOSTEARIC ACID, HYDROGEN DIMETHICONE, DISTEARDIMONIUM HECTORITE, BUTYLENE GLYCOL, CALCIUM STEARATE, TRISODIUM EDTA, ALUMINA, BHT, TRIETHOXYCAPRYLYLSILANE, SYZYGIUM JAMBOS LEAF EXTRACT, TOCOPHEROL, PHENOXYETHANOL, FRAGRANCE, TITANIUM DIOXIDE,

SHISEIDO EXTRA SMOOTH SUN PROTECTION N Other information

  • protect this product in this container from excessive heat and direct sun.

Questions or comments?

Call toll free 1-800-906-7503

SHISEIDO AMERICA INC.
NEW YORK, N.Y. 10022

SHISEIDO DIST.
NEW YORK • PARIS • MILANO

PRINCIPAL DISPLAY PANEL - 100mL Bottle Carton

S HI S EIDO

Anti-Aging Suncare

38

Extra Smooth
Sun Protection Lotion N

BROAD SPECTRUM
SPF 38

For Face/Body

WATER RESISTANT
(80 MINUTES)

SUNSCREEN

100mL 3.3 FL. OZ.

SHISEIDO EXTRA SMOOTH SUN PROTECTION N

SHISEIDO EXTRA SMOOTH SUN PROTECTION N

OCTINOXATE, OCTOCRYLENE, and ZINC OXIDE LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:52686-337
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 5424 mg
OCTOCRYLENE Octocrylene 3321 mg
Zinc Oxide Zinc oxide 13.84 g

Inactive Ingredients

Ingredient Name Strength
DIMETHICONE
water
DIPROPYLENE GLYCOL
ETHYLHEXYL PALMITATE
PEG-10 DIMETHICONE (600 CST)
talc
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)
Xylitol
GLYCERIN
METHYL GLUCETH-10
SCUTELLARIA BAICALENSIS ROOT
ECTOINE
isostearic acid
BUTYLENE GLYCOL
CALCIUM STEARATE
EDETATE TRISODIUM
ALUMINUM OXIDE
BUTYLATED HYDROXYTOLUENE
TRIETHOXYCAPRYLYLSILANE
SYZYGIUM JAMBOS LEAF
.ALPHA.-TOCOPHEROL
PHENOXYETHANOL
titanium dioxide

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 110.7 in 1 BOTTLE
2 NDC:52686-337-10 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2013-02-01


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