RADICAL SKINCARE SKIN PERFECTING SCREEN SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) LOTION [RADICAL BEAUTY USA INC]

RADICAL SKINCARE SKIN PERFECTING SCREEN SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) LOTION [RADICAL BEAUTY USA INC]
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NDC 62510-001-40
Set ID aea07c57-9c15-4662-9eca-ff049d8ecb35
Category HUMAN OTC DRUG LABEL
Packager RADICAL BEAUTY USA INC
Generic Name
Product Class
Product Number
Application Number PART352
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients:

    Zinc Oxide 7.75%
    Titanium Dioxide 5.87%

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
  • 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

    Keep out of reach of children.

    If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • apply liberally 15 minutes before sun exposure
    • reapply:
    • after 40 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 wish 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-sleeved shirts, pants, hats and sunglasses
    • children under 6 months: Ask a doctor
  • Inactive Ingredients

    Water, Caprylyl Methicone, PEG-10 Dimethicone, Isododecane, Titanium Dioxide, Alcohol, Caprylic/Capric Triglyceride, Polymethylsilsesquioxane, Methyl Methacrylate Crosspolymer, Sea Salt, Alumina, Methicone, Polyhydroxystearic Acid, Phenoxyethanol, Mica, Disodium EDTA, PEG-10, Glycerin, Isostearic Acid, Iron Oxides, Adenosine, Lecithin, Ascorbyl Tetraisopalmitate, Niacinamide, Tocopherol, Diamond Powder, Allantoin, Xanthum Gum, Camellia Sinensis Leaf Extract, Coffee Arabica (Coffee) Seed Extract, Pentylene Glycol, Superoxide Dismutase, Tromethamine

  • Other information

    • protect this product from excessive heat and direct sun
  • Questions or comments?

    Call toll free 1-800-519-1852

  • Principal Label

    RADICAL skincare

    SKIN PERFECTING
    SCREEN
    SPF 30

    Non-Chemical Sunscreen
    UV Broad Spectrum
    High Protection

    TRYLACEL ​™

    40mL 1.35 FL. OZ.

    For all skin types.

    The perfect partner of any Radical regimen, this lightweight matte lotion offers non-chemical sunscreen with high sunburn protection, and light diffusing pigments to visibly reduce the appearance of wrinkles and imperctions, a hint of tint for the perfect healthy radiance.

    Shake well before use.
    Use over moisturizer, prior to sun exposure. Keep out of eyes. Stop use if irritation occurs or increases. If irritation persists, consult a health care practitioner.

    RADICAL BEAUTY
    20 rue Cambon
    75001 PARIS - FRANCE
    made in France
    www.radicalskincare.com

    label

  • INGREDIENTS AND APPEARANCE
    RADICAL SKINCARE SKIN PERFECTING SCREEN SPF 30 
    zinc oxide, titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62510-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION77.5 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE58.7 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    ISODODECANE (UNII: A8289P68Y2)  
    ALCOHOL (UNII: 3K9958V90M)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SEA SALT (UNII: 87GE52P74G)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MICA (UNII: V8A1AW0880)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POLYETHYLENE GLYCOL 500 (UNII: 761NX2Q08Y)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    ADENOSINE (UNII: K72T3FS567)  
    ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    DIAMOND (UNII: 6GRV67N0U2)  
    ALLANTOIN (UNII: 344S277G0Z)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62510-001-401 in 1 CARTON
    140 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/10/2014
    Labeler - RADICAL BEAUTY USA INC (078605226)
    Registrant - Alban Muller International (647908011)

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