RAY DEFENSE SPF 30 SUNSCREEN (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LIQUID [BIOELEMENTS, INC. ]

RAY DEFENSE SPF 30 SUNSCREEN (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LIQUID [BIOELEMENTS, INC. ]
PDF | XML

NDC 49825-121-01, 49825-121-02
Set ID 5af44d4c-898a-4622-8c46-9676cd9124fb
Category HUMAN OTC DRUG LABEL
Packager Bioelements, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active ingredients               Purpose

    Avobenzone 2.0 %              Sunscreen

    Octinoxate 7.5 %                Sunscreen

    Octisalate 5.0 %                 Sunscreen

    Octocrylene 7.5 %               Sunscreen

    Oxybenzone 5.0%                Sunscreen


    Uses

    Helps prevent sunburn

    If used as directed with other sun protection measure (see Direction) decreases the risk of skin cancer and early skin aging caused by the sun.

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

    Stop use and ask a doctor if rash occurs

    Warnings


    For external Use only
    Do not use on broken skin.
    When using this product keep out of eyes. Rinse with water to remove.

    Directions

    Apply liberally 15 minutes before sun exposure

    Use a water resistant 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 Ingredients

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



    image of carton

  • PRINCIPAL DISPLAY PANEL

    Bioelements

    Ray Defense SPF 30

    Broad Spectrum SPF 30 Sunscreen

    Moisturizes and decreases the risk of early skin aging caused by the sun when used as directed.

    118 mL / 4 Fl.Oz.



    image of tube art

  • INGREDIENTS AND APPEARANCE
    RAY DEFENSE  SPF 30 SUNSCREEN
    avobenzone, octinoxate, octisalate, octocrylene, oxybenzone liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49825-121
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.0 mL  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mL  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5.0 mL  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7.5 mL  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5.0 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    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)  
    DIMETHICONOL (41 MPA.S) (UNII: 343C7U75XW)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    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)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49825-121-021 in 1 CARTON
    1NDC:49825-121-01118 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/23/2012
    Labeler - Bioelements, Inc. (174813923)
    Registrant - Bioelements, Inc. (174813923)
    Establishment
    NameAddressID/FEIBusiness Operations
    Neutraderm146224444manufacture

Related Drugs