SHISEIDO WHITE LUCENT DAY- avobenzone, octinoxate, and octocrylene emulsion

SHISEIDO WHITE LUCENT DAY by

Drug Labeling and Warnings

SHISEIDO WHITE LUCENT DAY by is a Otc medication manufactured, distributed, or labeled by SHISEIDO AMERICAS CORPORATION, Shiseido America 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 3.0%	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
• children under 6 months: ask a doctor
• 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

Inactive Ingredients

Water, SD Alcohol 40-B, Dimethicone, Dipropylene Glycol, Glycerin, Diisopropyl Sbeacate, Peg-60 Hydrogenated Castor Oil, Potassium Methoxysalicylate, Erythritol, Xanthan Gum, Tocopheryl Acetate, Peg/PPG-14/7 Dimethyl Ether, Peg/PPG-17/4 Dimethyl Ether, Dipotassium Glycyrrhizate, 2-O-Ethyl Ascorbic Acid, Caffeine, Ascorbyl Tetraisopalmitate, Phytosteryl Macadamiate, Angelica Keiskei Leaf/Stem Extract, Paeonia Albiflora Root Extract, Cratagus Monogyna Flower Extract, Rehmannia Chinesis Root Extract, Ziziphu Jujuba Fruit Extract, Polyquaternium 51, PPG-17, Peg-240/HDI Copolymer BIS-Decyltetradeceth-20 Ether, Triethanolamine, Silica, Butylene Glycol, Isostearic Acid, PPG-3 Dipivalate, HDI/Trimethylol Hexyllactone Crosspolymer, Carbomer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, BHT, Sodium Metaphosphate, Alcohol, Tocopherol, Disodium EDTA, Sodium Metabisulfite, Prunus Yedoensis Leaf Extract, Phenoxyethanol, Benzoic Acid, Fragrance, Titanium Dioxide, Mica, 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

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton

SHISEIDO
GINZA TOKYO

White Lucent

Day Emulsion

BROAD SPECTRUM
SPF 23

SUNSCREEN

ReNeura Technology+™

50mL NET WT. 1.7 OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO WHITE LUCENT DAY 
avobenzone, octinoxate, and octocrylene emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-463
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.285 g  in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.8036 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1.542 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)
POTASSIUM METHOXYSALICYLATE (UNII: 5G3H7U4Y7F)
ERYTHRITOL (UNII: RA96B954X6)
XANTHAN GUM (UNII: TTV12P4NEE)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
PEG/PPG-17/4 DIMETHYL ETHER (UNII: 4ET18WJG5K)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K)
CAFFEINE (UNII: 3G6A5W338E)
ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)
PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M)
ANGELICA KEISKEI TOP (UNII: AP628M4TQO)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
CRATAEGUS MONOGYNA FLOWER (UNII: NT52AMP29J)
REHMANNIA GLUTINOSA ROOT (UNII: 1BEM3U6LQQ)
JUJUBE FRUIT (UNII: G55HNL2C70)
POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
PPG-17 (UNII: OV0Q322E0U)
TROLAMINE (UNII: 9O3K93S3TK)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ISOSTEARIC ACID (UNII: X33R8U0062)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
ALCOHOL (UNII: 3K9958V90M)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
PRUNUS X YEDOENSIS LEAF (UNII: 1Z125GA907)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZOIC ACID (UNII: 8SKN0B0MIM)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-463-10	1 in 1 CARTON	01/01/2019
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/01/2019

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICAS INC.		782677132	MANUFACTURE(58411-463) , ANALYSIS(58411-463)