SUN PROTECTIVE DAY MOISTURIZER SUNSCREEN- avobenzone, octinoxate, octocrylene and oxybenzone cream

SUN PROTECTIVE DAY MOISTURIZER SUNSCREEN by

Drug Labeling and Warnings

SUN PROTECTIVE DAY MOISTURIZER 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 3%

Octinoxate 7.5%

Octocrylene 10%

Oxybenzone 6%

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 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)

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

SUN PROTECTIVE DAY MOISTURIZER SUNSCREEN 
avobenzone, octinoxate, octocrylene and oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70081-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70081-002-50	1 in 1 CARTON	10/24/2015
1		50 mL in 1 BOTTLE, PUMP; 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	10/24/2015

Labeler - Dr Russo Skincare Ltd (217516653)

Establishment
Name	Address	ID/FEI	Business Operations
Orean Personal Care Ltd.		211403363	manufacture(70081-002)