Label: STRYX DAILY MOISTURIZER SPF-30- octisalate, ensulizole cream

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 11, 2023

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  • Drug Facts

  • Active Ingredients

    Octisalate 5.00%

    Phenylbenzimidazole Sulfonic Acid 4.00%

    Purpose

    Sunscreen

  • Uses:

    - Helps prevent sunburn

    - Higher SPF gives more sunburn protection

    - 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 not intended for ingestion

    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

    i rash or irritation develops and lasts

    Keep out of reach of children

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

  • Directions:

    - Apply liberally 15 minutes before sun exposure

    - Children under 6 months of age: ask a doctor 

    - Reapply: 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 broad spectrum SPF of 15 or higher and other sun protection measures including:

    1. Limit time in the sun, especially from 10 a.m.- 2 p.m.
    2. Wear long-sleeved shirts, pants, hats, and sunglasses
  • Other Information:

    - Protect the product in this container from excessive heat and direct sun

  • Inactive Ingredients:

    Acrylates Copolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Bisabalol, Butyl Methoxydibenzoylmethane, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Cetearyl Olivate, Cetyl Alcohol, Cocos Nucifera (Coconut) Oil, Dimethicone, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Hyaluronic Acid, Hydrolyzed Oat Protein, Malus Domestica (Apple) Fruit Cell Culture Extract, Olea Europaea (Olive) Oil, Palmitoyl Tripeptide-5, Pentylene GLycol, Phenoxyethanol, Phenylethyl Resorcinol, Polysorbate-20, Sodium Hydroxide, Sorbitan Olivate, Stearyl Alcohol, Tocopheryl Acetate (Vitamin E), Tridecyl Salicylate, Xanthan Gum

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    STRYX DAILY MOISTURIZER SPF-30 
    octisalate, ensulizole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82281-239
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE40 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    AVOBENZONE (UNII: G63QQF2NOX)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    APPLE (UNII: B423VGH5S9)  
    OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)  
    PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PHENYLETHYL RESORCINOL (UNII: G37UFG162O)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82281-239-00100 mL in 1 TUBE; Type 0: Not a Combination Product10/10/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02010/10/2021
    Labeler - STRYX MEN, INC. (083655323)
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