SHISEIDO THE SKINCARE DAY MOISTURE PROTECTION- avobenzone, octinoxate, and octocrylene emulsion

SHISEIDO THE SKINCARE DAY MOISTURE PROTECTION by

Drug Labeling and Warnings

SHISEIDO THE SKINCARE DAY MOISTURE PROTECTION by is a Otc medication manufactured, distributed, or labeled by SHISEIDO AMERICA INC., Davlyn Industries Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

ACTIVE INGREDIENTS:	Purpose
AVOBENZONE 2.5%	Sunscreen
OCTINOXATE 7.4%	Sunscreen
OCTOCRYLENE 2.0%	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

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
• use a water resistant sunscreen 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. – 2 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor

Inactive Ingredients

WATER, GLYCERIN, DIPROPYLENE GLYCOL, DIPHENYLSILOXY PHENYL TRIMETHICONE, SD ALCOHOL 40-B, XYLITOL, BUTYLENE GLYCOL, DIMETHICONE, POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER, PEG-60 GLYCERYL ISOSTEARATE, XANTHAN GUM, ERYTHRITOL, TREHALOSE, PEG/PPG-14/7 DIMETHYL ETHER, SCUTELLARIA BAICALENSIS ROOT EXTRACT, HYDROXYPROPYL CYCLODEXTRIN, MENTHA PIPERITA (PEPPERMINT) LEAF EXTRACT, SODIUM HYALURONATE, CITRUS JUNOS SEED EXTRACT, PHYTOSTERYL MACADAMIATE, STEARIC ACID, GLYCERYL STEARATE SE, BEHENYL ALCOHOL, ISOSTEARIC ACID, BEHENIC ACID, BEHENETH-20, TRIETHANOLAMINE, CARBOMER, ALCOHOL, TRISODIUM EDTA, BHT, TOCOPHEROL, PHENOXYETHANOL, FRAGRANCE,

Other information

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

Questions or comments?

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 75mL Bottle Carton

SHISEIDO

The Skincare

Day
Moisture Protection

BROAD SPECTRUM
SPF 18

SUNSCREEN

75mL 2.5 FL. OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO THE SKINCARE DAY MOISTURE PROTECTION 
avobenzone, octinoxate, and octocrylene emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-333
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1935 mg  in 77.4 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	5728 mg  in 77.4 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1548 mg  in 77.4 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
XYLITOL (UNII: VCQ006KQ1E)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-60 GLYCERYL ISOSTEARATE (UNII: WQP0973914)
TROLAMINE (UNII: 9O3K93S3TK)
DIMETHICONE (UNII: 92RU3N3Y1O)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARIC ACID (UNII: 4ELV7Z65AP)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DOCOSANOL (UNII: 9G1OE216XY)
BEHENIC ACID (UNII: H390488X0A)
BEHENETH-20 (UNII: BJ4GP2IFLN)
ISOSTEARIC ACID (UNII: X33R8U0062)
XANTHAN GUM (UNII: TTV12P4NEE)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
ERYTHRITOL (UNII: RA96B954X6)
TREHALOSE (UNII: B8WCK70T7I)
ALCOHOL (UNII: 3K9958V90M)
EDETATE TRISODIUM (UNII: 420IP921MB)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MENTHA PIPERITA LEAF (UNII: A389O33LX6)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CITRUS JUNOS SEED (UNII: UY43O1Q45N)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-333-10	1 in 1 CARTON
1		77.4 g in 1 BOTTLE
2	NDC: 52686-333-11	1 in 1 CARTON
2		7.22 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	11/01/2012

Labeler - SHISEIDO AMERICA INC. (782677132)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	MANUFACTURE(52686-333) , ANALYSIS(52686-333)

Establishment
Name	Address	ID/FEI	Business Operations
Davlyn Industries Inc		624436254	MANUFACTURE(52686-333)