SAYUKI BROAD SPECTRUM SPF 30 ANTI-AGING DAILY MOISTURIZER SUNSCREEN- avobenzone, octinoxate, octisalate, oxybenzone lotion

Sayuki Broad Spectrum SPF 30 Anti-Aging Daily Moisturizer Sunscreen by

Drug Labeling and Warnings

Sayuki Broad Spectrum SPF 30 Anti-Aging Daily Moisturizer Sunscreen by is a Otc medication manufactured, distributed, or labeled by Sayuki Custom Cosmetics, Columbia Cosmetics Manufacturing, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Purpose

Sunscreen

Active ingredients:

AVOBENZONE (3.0%)
OCTINOXATE (7.5%)
OCTISALATE (5.0%)
OXYBENZONE (4.0%)

Uses:

• helps prevent sunburn
• if used as directed with other sun protection measure (see Directions), decrease 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.

Stop use and ask a doctor

if rash occurs.

When using this product

keep out of eyes.  Rinse with water to remove.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

• 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 value of 15 or higher and other sun protection measures including:

• limit time in the sun 10 AM to 2 PM
• wear long-sleeved shirts, pants, hats and sunglasses.
  

Inactive ingredients:

Water (Aqua), Isopropyl Palmitate, Isoeicosane, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Potassium Cetyl Phosphate, Glycerin, Cetyl Dimethicone, Ethyhexyl Methoxycrylene, Silica, Dimethicone, Polyglyceryl-3 Diisostearate, Cetearyl Alcohol, Hydroxyethylcellulose, Phenoxyethanol, Glyceryl Stearate, Peg-100 Stearate, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Butylene Glycol, Camelia Oleifera Leaf Extract, Punica Granatum Fruit Extract.

Other information:

• protect this product from excessive heat and direct sun.

PRINCIPAL DISPLAY PANEL

Sayuki Anti-Aging Daily Moisturizer  Sunscreen Lotion BROAD SPECTRUM SPF 30 PABA FREE   FRAGRANCE FREE   OIL FREE    DYE FREE    FACE AND BODY PROTECTION    FOR ACTIVE LIFESTYLE     1 FL. OZ  (30ml)  made in USA   Distributed by Sayuki Custom Cosmetics, Inc.  Trabuco Canyon, Californina, 92679 USA  Sayuki Creates Happiness

Sayuki Broad Spectrum SPF 30 Anti-Aging Daily Moisturizer Sunscreen Lotion 1oz/30ml (

49517-0001-1)

INGREDIENTS AND APPEARANCE

SAYUKI BROAD SPECTRUM SPF 30 ANTI-AGING DAILY MOISTURIZER SUNSCREEN 
avobenzone, octinoxate, octisalate, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49517-0001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
ISOEICOSANE (UNII: AR294KAG3T)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POMEGRANATE (UNII: 56687D1Z4D)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49517-0001-1	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/19/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/19/2012

Labeler - Sayuki Custom Cosmetics (078441229)

Establishment
Name	Address	ID/FEI	Business Operations
Columbia Cosmetics Manufacturing, Inc.		068267863	manufacture(49517-0001)