Label: SUN PROTECTIVE DAY MOISTURIZER SUNSCREEN- avobenzone, octinoxate, octocrylene and oxybenzone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 70081-002-50 - 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 24, 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 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
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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
- Questions or comments?
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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
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INGREDIENTS AND APPEARANCE
SUN PROTECTIVE DAY MOISTURIZER SUNSCREEN
avobenzone, octinoxate, octocrylene and oxybenzone creamProduct 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)
