Label: SUN PROTECTIVE DAY CLEANSER SUNSCREEN- avobenzone, octinoxate and octocrylene cream
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Contains inactivated NDC Code(s)
NDC Code(s): 70081-001-10 - Packager: Dr Russo Skincare Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated October 26, 2015
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients
- Purpose
- KEEP OUT OF REACH OF CHILDREN
- Uses
- Warnings
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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
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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
- Questions or comments?
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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
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INGREDIENTS AND APPEARANCE
SUN PROTECTIVE DAY CLEANSER SUNSCREEN
avobenzone, octinoxate and octocrylene creamProduct 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)
