DR. NIKKO SHEER SUNSCREEN BROAD SPECTRUM SPF 40- octinoxate, octisalate, and ensulizole cream

Dr. Nikko Sheer Sunscreen Broad Spectrum SPF 40 by

Drug Labeling and Warnings

Dr. Nikko Sheer Sunscreen Broad Spectrum SPF 40 by is a Otc medication manufactured, distributed, or labeled by Nikko Cosmetic Surgery Center, CIT Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Octinoxate - 7.0%
Octisalate - 4.5%
Ensulizole - 2%

Purpose

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

• Apply liberally 15 minutes before sun exposure.
• 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, Diethylamino Hydroxybenzoyl Hexyl Benzoate, C12-15 Alkyl Benzoate, Cetearyl Olivate, Cetearyl Alcohol, Methyl Methacrylate Crosspolymer, Glyceryl Stearate, Sorbitan Olivate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Polyacrylate-13, Polysorbate 60, Dimethicone, Polyisobutene, Caprylyl Glycol, Sodium Hydroxide, Sorbitan Stearate, Ethylhexylglycerin, PEG-100 Stearate, Fragrance, Polysorbate 20, Sorbitan Isostearate, 1,2-Hexanediol, Disodium EDTA, Butylene Glycol, Prunus Amygdalus Dulcis (sweet Almond) Seed Extract, Pinus Sylvestris Bark Extract, Caprylic/Capric Triglyceride, Polyglyceryl-10 Diisostearate, Hydrogenated Lecithin, Phenoxyethanol, Pistacia Lentiscus (Mastic) Gum, Zingiber Officinale (Ginger) Root Extract, Tetrasodium EDTA, Hydrolyzed Hyaluronic Acid.

Other information

• Protect this product from excessive heat and direct sun.
• Report serious adverse event to:
  Nikko Cosmetic Surgery Center
  4707 Eigel St Suite 100 Houston, TX 77007

Questions or comments?

832-906-2900 / M-T 9am -5pm F 9am-3pm

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton

DR NIKKO
SKIN CARE

SHEER
SUNSCREEN
WITH SKIN MATRIX COMPLEX

SWEET ALMOND EXTRACT
PINE BARK EXTRACT

BROAD SPECTRUM

SPF 40

1.7 FL OZ (50mL)

INGREDIENTS AND APPEARANCE

DR. NIKKO SHEER SUNSCREEN BROAD SPECTRUM SPF 40 
octinoxate, octisalate, and ensulizole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71651-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	70 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	45 mg  in 1 mL
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
POLYSORBATE 60 (UNII: CAL22UVI4M)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SORBITAN OLIVATE (UNII: MDL271E3GR)
BEMOTRIZINOL (UNII: PWZ1720CBH)
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PEG-100 STEARATE (UNII: YD01N1999R)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALMOND (UNII: 3Z252A2K9G)
PINUS SYLVESTRIS BARK (UNII: M402HHT991)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PISTACIA LENTISCUS RESIN (UNII: 7446H202QW)
GINGER (UNII: C5529G5JPQ)
EDETATE SODIUM (UNII: MP1J8420LU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71651-001-01	1 in 1 CARTON	05/01/2018	06/30/2021
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 not final	part352	05/01/2018	06/30/2021

Labeler - Nikko Cosmetic Surgery Center (965124634)

Establishment
Name	Address	ID/FEI	Business Operations
CIT Co.,Ltd.		690081646	manufacture(71651-001)