SUN PROTECTIVE DAY MOISTURIZER SUNSCREEN- avobenzone, octinoxate, octocrylene and oxybenzone cream 
Dr Russo Skincare Ltd

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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SUN PROTECTIVE DAY MOISTURIZER SUNSCREEN

Drug Facts

Active ingredients

Avobenzone 3%

Octinoxate 7.5%

Octocrylene 10%

Oxybenzone 6%

Purpose

Sunscreen

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 at least every 2 hours

• use a water resistant sunscreen if swimming or sweating

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

Aqua (Water), Acacia Decurrens/Jojoba/Sunflower Seed Cera/ Polyglyceryl-3 Esters, Glycerin, Ascorbyl Glucoside, Tapioca Starch, 1-Methylhydantoin-2-lmide, Adansonia Digitata (Baobab) Seed Oil, Stearic Acid, Butylene Glycol, Caprylic/Capric Glycerides, Betaine, Dimethicone, Phenoxyethanol, Cyclopentasiloxane, Propylene Glycol, Lecithin, Sodium Hyaluronate, Tocopherol, Benzyl Alcohol, Fragrance (Parfum), Sodium Stearoyl Glutamate, Polysilicone-11, Polyacrylamide, Xanthan Gum, Camellia Sinensis Leaf Extract, Disodium EDTA, C13-14 Isoparaffin, Sodium Stearate, Polymethylsilsesquioxane, Dehydroacetic Acid, Laureth-7, Hordeum Distichon (Barley) Extract, Sodium Benzoate, Melissa Officinalis Leaf Extract, Disodium Rutinyl Disulfate, Ethylbisiminomethylguaiacol Manganese Chloride, Citric Acid, Aspalathus Linearis Leaf Extract, Glyceryl Stearate SE.

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)

BROAD SPECTRUM SPF 30

Dr Russo’s Sun Protective Day Moisturizer Sunscreen has been specifically formulated to moisturise 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 during the day.

“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 day moisturiser 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

daymois1

SUN PROTECTIVE DAY MOISTURIZER SUNSCREEN 
avobenzone, octinoxate, octocrylene and oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70081-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ACACIA DECURRENS WHOLE (UNII: 8KZ75S2VSK)  
JOJOBA OIL (UNII: 724GKU717M)  
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
GLYCERIN (UNII: PDC6A3C0OX)  
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
STARCH, TAPIOCA (UNII: 24SC3U704I)  
CREATININE (UNII: AYI8EX34EU)  
ADANSONIA DIGITATA SEED OIL (UNII: 77MKL7AR5I)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PEG-6 CAPRYLIC/CAPRIC GLYCERIDES (UNII: GO50W2HWO8)  
BETAINE (UNII: 3SCV180C9W)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
TOCOPHEROL (UNII: R0ZB2556P8)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
XANTHAN GUM (UNII: TTV12P4NEE)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
SODIUM STEARATE (UNII: QU7E2XA9TG)  
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
LAURETH-7 (UNII: Z95S6G8201)  
BARLEY (UNII: 5PWM7YLI7R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)  
DISODIUM RUTINYL DISULFATE (UNII: V5J3537PND)  
ETHYLBISIMINOMETHYLGUAIACOL MANGANESE CHLORIDE (UNII: SM5YJ88LTU)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70081-002-501 in 1 CARTON10/24/2015
150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/24/2015
Labeler - Dr Russo Skincare Ltd (217516653)
Establishment
NameAddressID/FEIBusiness Operations
Orean Personal Care Ltd.211403363manufacture(70081-002)

Revised: 10/2015
Document Id: 39dd88a7-86de-4eaa-a58d-59ec1d489b3f
Set id: 1f0b9c30-d489-4c06-9109-88b909e4c4bd
Version: 1
Effective Time: 20151024
 
Dr Russo Skincare Ltd