RECLARX MOISTURE SHIELD (OCTOCRYLENE AND AVOBENZONE) CREAM [NBC AESTHETICS, LLC]

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RECLARX MOISTURE SHIELD (OCTOCRYLENE AND AVOBENZONE) CREAM [NBC AESTHETICS, LLC]
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NDC 61402-7131-1
Set ID 32c6046a-5e70-4803-94b3-11f4dbafcfc1
Category HUMAN OTC DRUG LABEL
Packager NBC Aesthetics, LLC
Generic Name
Product Class
Product Number
Application Number PART352
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Octocrylene 7%, Butyl Methoxydibenzoylmethane 2%

  • Purpose

    Sunscreen

  • 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 damage or broken skin.

    When using this product, keep out of eyes. Rinse with water to remove.

    Stop use and ask doctor if rash occurs.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Apply liberally to face and neck after Step 3 at least 15 minutes before sun exposure.

    • Use a water resistant sunscreen if swimming or sweating
    • reapply 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 the risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including

    • limit time in the sun, especially from 10am-2pm
    • wear long-sleeved shirts, pants, hats and sunglasses
    • children under 6 months of age: Ask a doctor.
  • Other Information

    Protect this product from excessive heat and direct sun.

  • Inactive Ingredients

    Aloe Barbadensis Leaf Juice, Bambusa Vulgaris (Bamboo) Leaf/Stem Extract, Butylene Glycol, Butyrospermum Parkii (Shea Butter), Calendula Officinalis Seed Oil, Caprylic/Capric Triglyceride, Caprylyl Glycol, Carbomer, Cera Alba (Beeswax), Cetyl Alcohol, Dimethicone, Fragrance (Perfume), Glycerin, Glyceryl Stearate SE, Isopropyl Myristate, Lavandula Angustifolia (Lavender) Extract, Maris Aqua (Dead Sea Water), Nordihydroguaiaretic Acid, Peg-40 Stearate, Olea Europaea (Olive) Fruit Oil, Oleanolic Acid, Peg-60 Almond Glycerides, Persea Gratissima (Avocado) Oil, Phenoxyethanol, Rosa Canina Fruit, Rosmarinus Officinalis (Rosemary) Leaf Extract, Salicylic Acid, Simmondsia Chinensis (Jojoba) Seed Oil, Theobroma Cacao (Cocoa) Seed Butter, Triethylene Glycol, Vitis Vinifera (Grape) Seed Oil, Water.

  • Questions or Comments:

    Call 1-800-397-7191, Mon-Fri

  • Principal Display Panel - Bottle Label

    Reclarx™ BD

    Blemish-Defying Regimen

    All Skin Types

    Moisture Shield

    Sunscreen

    Broad Spectrum

    SPF 15

    STEP
    4

    AM/PM

    Locks In moisture and provides UVA/UVB
    protection against the elements

    DERMATOLOGIST TESTED • NOT TESTED ON ANIMALS

    Exclusively distributed by: NBC Aesthetics, LLC • 23715 Mercantile Road • Beachwood, Ohio 44122 • info@reclarx.com • www.reclarx.com

    Principal Display Panel - Bottle Label
  • INGREDIENTS AND APPEARANCE
    RECLARX MOISTURE SHIELD 
    octocrylene and avobenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61402-7131
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7 g  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CALENDULA OFFICINALIS SEED OIL (UNII: 9JS8DS42SV)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PEG-60 ALMOND GLYCERIDES (UNII: 4Y0E651N0F)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    MASOPROCOL (UNII: 7BO8G1BYQU)  
    OLEANOLIC ACID (UNII: 6SMK8R7TGJ)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    PEG-40 STEARATE (UNII: ECU18C66Q7)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)  
    JOJOBA OIL (UNII: 724GKU717M)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BAMBUSA VULGARIS TOP (UNII: FIW80T6P6V)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
    ROSEMARY (UNII: IJ67X351P9)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    TRIETHYLENE GLYCOL (UNII: 3P5SU53360)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61402-7131-150 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/01/2015
    Labeler - NBC Aesthetics, LLC (078882808)
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