SUN PROTECTIVE DAY CLEANSER SUNSCREEN- avobenzone, octinoxate and octocrylene cream

SUN PROTECTIVE DAY CLEANSER SUNSCREEN by

Drug Labeling and Warnings

SUN PROTECTIVE DAY CLEANSER SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by Dr Russo Skincare Ltd, Orean Personal Care Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Avobenzone 2.75%

Octinoxate 7.2%

Octocrylene 7.04%

Purpose

Sunscreen

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

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.

Directions

Shake well before use

apply liberally 15 minutes before sun exposure

reapply:

   after 80 minutes of swimming or sweating

   immediately after towel drying

   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, Sodium Lauryl Sulfate, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Polyquaternium-10, Glycerin, Dimethicone, Sorbitan Monooleate, Polyamide-3, Polysorbate 20, Gellan Gum, PG-Hydroxyethylcellulose Stearyldimonium Chloride, Carboxymethylcellulose Na, Cocodimonium Hydroxypropyl Hydrolyzed Keratin, Sodium Alginate, Lauryldimoniumhydroxypropyl Decylglucosides Chloride, Carrageenan, Sodium Lauryl Glucose Carboxylate, Butyrospermum Park (Shea) Oil, Lauryl Glucoside, Sorbitan Stearate, Tetrasodium EDTA, Acrylates/C12-22 Alkyl Methacrylate Copolymer, RubeusIdaeus (Red Raspberry) Oil, Punica Granatum (Pomegranate) Seed Oil, Vaccinium Macrocarpon (Cranberry) Seed Oil, Camellia Oleifera Seed Oil, Vitis Vinifera (Grape) Seed Oil, Arctium Lappa (Burdock Root) Extract, Phenoxyethanol, Caprylyl Glycol, Sodium Chloride, Citric Acid

Other information

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

Questions or comments?

Call Toll free 1-800-295-7051

Monday - Friday 9-12 a.m (EST)

SPL UNCLASSIFIED SECTION

BROAD SPECTRUM SPF 30

WATER RESISTANT (80 MINUTES)

Dr Russo’s Sun Protective Day Cleanser Sunscreen has been specifically formulated to gently cleanse your skin and protect it from UVA/UVB exposure. UV rays are prevalent all year round. It is important to prevent exposure to UVA and UVB at all times.

“As a cosmetic surgeon, I see the effects of sun exposure on my patient’s skin, every day. As a scientist I know that it can be prevented. This exclusive Sunscreen Day Cleanser is formulated to deliver a broad spectrum UVA/UVB SPF 30 sunscreen”.

Dr Mario Luca Russo, MD

Dr Russo is a leading European cosmetic derma surgeon and founder of The Rejuvenation Clinic & Medispa, known worldwide for its pioneering work on sun damaged and prematurely ageing skin. He is a member of the British Association of Dermatologists, the American Academy of Cosmetic Surgery and a fellow of the American Society of Laser in Medicine and Surgery.

Manufactured for:

Dr Russo Skincare Ltd

102 Harley Street

London W1G 7JB

England

Made in UK

www.drrussoskincare.com

Packaging

INGREDIENTS AND APPEARANCE

SUN PROTECTIVE DAY CLEANSER SUNSCREEN 
avobenzone, octinoxate and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70081-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.75 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.2 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	7.04 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
POLYQUATERNIUM-10 (125 MPA.S AT 2%) (UNII: L45WU8S981)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
GELLAN GUM (LOW ACYL) (UNII: 7593U09I4D)
PROPYLENE GLYCOL-HYDROXYETHYLCELLULOSE STEARYLDIMONIUM CHLORIDE (UNII: 3479326GXB)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
HYDROLYZED ELASTIN, BOVINE, ALKALINE (1000 MW) (UNII: ZR28QKN0WT)
SODIUM ALGINATE (UNII: C269C4G2ZQ)
HYDROXYETHYL LAURDIMONIUM CHLORIDE (UNII: 8467K53E3Y)
CARRAGEENAN (UNII: 5C69YCD2YJ)
SODIUM LAURYL GLYCOL CARBOXYLATE (UNII: 8L0472VMYL)
SHEANUT OIL (UNII: O88E196QRF)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
EDETATE SODIUM (UNII: MP1J8420LU)
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
RASPBERRY SEED OIL (UNII: 9S8867952A)
PUNICA GRANATUM SEED OIL (UNII: 0UI45XV0T6)
CRANBERRY SEED OIL (UNII: 73KDS3BW5E)
CAMELLIA OIL (UNII: T1PE06G0VE)
VITIS VINIFERA SEED (UNII: C34U15ICXA)
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70081-001-10	1 in 1 CARTON	10/26/2015
1		100 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	10/26/2015

Labeler - Dr Russo Skincare Ltd (217516653)

Establishment
Name	Address	ID/FEI	Business Operations
Orean Personal Care Ltd.		211403363	manufacture(70081-001)