RAY DEFENSE BROAD SPECTRUM SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [BIOELEMENTS]

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  • RAY DEFENSE BROAD SPECTRUM SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [BIOELEMENTS]

RAY DEFENSE BROAD SPECTRUM SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [BIOELEMENTS]
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NDC 49825-138-01, 49825-138-02, 49825-138-03, 49825-138-04
Set ID 807db1ff-a64a-44e4-a786-f88cd4518433
Category HUMAN OTC DRUG LABEL
Packager Bioelements
Generic Name
Product Class
Product Number
Application Number PART352
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  • ACTIVE INGREDIENT

    Active Ingredients           Purpose

    Avobenzone 2.0% ......... Sunscreen

    Octinoxate 7.5% ........... Sunscreen

    Octisalate 5.0% ............ Sunscreen

    Octocrylene 7.0% ......... Sunscreen

    Oxybenzone 5.0% ........ Sunscreen

  • PURPOSE

    • 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
  • 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

  • INDICATIONS & USAGE

    Stop use and ask a doctor if rash occurs

  • 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.

  • DOSAGE & ADMINISTRATION

    • Apply liberally 15 minutes before sun exposure
    • Use a water resistan sunscreen if swimming or sweating
    • Reapply at least every 2 hours
    • Children under 6 months: Ask a doctor
    • 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 
  • INACTIVE INGREDIENT

    Inactive Ingredients

    Allantoin, Aloe Barbadensis Leaf Extract, C12-15 Alkyl Benzoate, Camellia Oleifera Leaf Extract, Caprylic/Capric Triglyceride, Carbomer, Cetyl Alcoho, Cahmomilla Recutita (Matricaria) Flower Extract, Citrus Aurantium Amara (Bitter Orange) Flower Oil, Citrus Reticulata (Tangerine) Leaf Oil, Cyclopentasiloxane Dimethicone, Dimethiconol, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Glycol Distearate, Isohexadecane, Lavandula Angustifolia (Lavender) Oil, Lavandula Hybrida Oil, PEG-100 Stearate, Polysorbate 80, Potassium Cetyl Phosphate, Phenoxyethanol, Salvia Officinalis (Sage) Oil, Salvia Sclarea (Clary) Oil, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Sodium Hydroxide, Stearyl Alcohol, Tetrasodium EDTA, Titanium Dioxide, Tocopheryl Acetate, Water (Aqua, Eau)

  • PRINCIPAL DISPLAY PANEL

    Ray Defense

    Broad Spectrum

    SPF 30 Sunscreen

    59 mL. / 2 Fl. OZ

    Primary

    Secondary

  • INGREDIENTS AND APPEARANCE
    RAY DEFENSE  BROAD SPECTRUM SPF 30
    avobenzone, octinoxate, octisalate, octocrylene, oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49825-138
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7 g  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CHAMOMILE (UNII: FGL3685T2X)  
    CITRUS AURANTIUM FLOWER OIL (UNII: D4BGE91OXH)  
    CITRUS RETICULATA LEAF OIL (UNII: 1515UE78IH)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    LAVANDIN OIL (UNII: 9RES347CKG)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SAGE OIL (UNII: U27K0H1H2O)  
    CLARY SAGE OIL (UNII: 87L0D4U3M0)  
    SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49825-138-021 in 1 PACKAGE04/27/2015
    1NDC:49825-138-0159 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:49825-138-041 in 1 PACKAGE04/27/2015
    2NDC:49825-138-03118 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/27/2015
    Labeler - Bioelements (174813923)
    Registrant - Bioelements (174813923)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetic Enterprises017701475manufacture(49825-138)
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