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

SHISEIDO THE SKINCARE DAY MOISTURE PROTECTION ENRICHED by

Drug Labeling and Warnings

SHISEIDO THE SKINCARE DAY MOISTURE PROTECTION ENRICHED 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, BUTYLENE GLYCOL, GLYCERIN, DIPHENYLSILOXY PHENYL TRIMETHICONE, DIPROPYLENE GLYCOL, XYLITOL, SD ALCOHOL 40-B, PEG-60 GLYCERYL ISOSTEARATE, ISOSTEARIC ACID, SILICA, BENTONITE, POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER, GLYCERYL STEARATE SE, ERYTHRITOL, XANTHAN GUM, 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, HYDROGENATED POLYDECENE, STEARYL ALCOHOL, BEHENYL ALCOHOL, PEG-5 GLYCERYL STEARATE, STEARIC ACID, TRISODIUM EDTA, SODIUM HYDROXIDE, BEHENIC ACID, ALCOHOL, SODIUM METAPHOSPHATE, BHT, TOCOPHEROL, PHENOXYETHANOL, FRAGRANCE, IRON OXIDES,

Other information

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

Questions or comments?

Call toll free 1-800-906-7503

SPL UNCLASSIFIED SECTION

SHISEIDO AMERICA INC. NEW YORK, N.Y. 10022
SHISEIDO DIST. NEW YORK PARIS MILANO

PRINCIPAL DISPLAY PANEL - 50mL Jar Carton

SHISEIDO

The Skincare

Day
Moisture Protection
Enriched

BROAD SPECTRUM
SPF 18

SUNSCREEN

50mL NET WT. 1.8 OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO THE SKINCARE DAY MOISTURE PROTECTION ENRICHED 
avobenzone, octinoxate, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-334
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1316 mg  in 52.65 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3896 mg  in 52.65 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1053 mg  in 52.65 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
XYLITOL (UNII: VCQ006KQ1E)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
PEG-60 GLYCERYL ISOSTEARATE (UNII: WQP0973914)
BENTONITE (UNII: A3N5ZCN45C)
ISOSTEARIC ACID (UNII: X33R8U0062)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
DOCOSANOL (UNII: 9G1OE216XY)
PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
EDETATE TRISODIUM (UNII: 420IP921MB)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
BEHENIC ACID (UNII: H390488X0A)
XANTHAN GUM (UNII: TTV12P4NEE)
TREHALOSE (UNII: B8WCK70T7I)
ERYTHRITOL (UNII: RA96B954X6)
ALCOHOL (UNII: 3K9958V90M)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MENTHA PIPERITA LEAF (UNII: A389O33LX6)
CITRUS JUNOS SEED (UNII: UY43O1Q45N)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-334-50	1 in 1 CARTON
1		52.65 g in 1 JAR

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(52686-334) , ANALYSIS(52686-334)

Establishment
Name	Address	ID/FEI	Business Operations
Davlyn Industries Inc		624436254	MANUFACTURE(52686-334)