Label: JURLIQUE SUN SUNSCREEN SPF 30- octinoxate, octisalate, oxybenzone, and titanium dioxide cream, augmented

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated November 21, 2012

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Octinoxate 7.5%
    Octisalate 2.0%
    Oxybenzone 5.0%
    Titanium dioxide 2.1%

  • Purpose

    Sunscreen

  • Use

    Helps prevent sunburn

  • Warnings

    Skin Cancer/Skin Aging Alert

    Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

    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
    • use a water resistant sunscreen if swimming or sweating
    • reapply at least every 2 hours
    • children under 6 months: Ask a doctor
  • Other information

    • protect this product from excessive heat and direct sunlight
    • store below 25°C/77°F
    • you may report a serious adverse reaction to Report Reaction, LLC PO Box 22, Plainsboro, NJ 08536-0222
  • Inactive ingredients

    Water, Glycerin, Ethylhexyl Stearate, Caprylic/Capric Triglyceride, Potassium Cetyl Phosphate, Glyceryl Stearate, Persea Gratissima (Avocado) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Ethylhexyl Palmitate, Dimethicone, Trimethylsiloxysilicate, Hydrolyzed Wheat Protein, Tocopheryl Acetate, Sodium Hydroxymethylglycinate, Lactic Acid, Alumina, Stearic Acid, Xanthan Gum, Cetyl Alcohol, Lavandula Angustifolia (Lavender) Oil, Pinus Sylvestris (Pine) Leaf Oil, Cupressus Sempervirens (Cypress) Oil, Citrus Aurantium Amara (Bitter Orange) Oil, Linalool, Limonene.

  • PRINCIPAL DISPLAY PANEL - 100mL Bottle Carton

    Jurlique

    Sun Lotion

    SPF 30

    A protective sunscreen lotion

    100mL 3.3 Fl. Oz.

    PRINCIPAL DISPLAY PANEL - 100mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    JURLIQUE SUN SUNSCREEN SPF 30 
    octinoxate, octisalate, oxybenzone, and titanium dioxide cream, augmented
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68105-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate75 mg  in 1 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate20 mg  in 1 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone50 mg  in 1 mL
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide21 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Ethylhexyl Stearate (UNII: EG3PA2K3K5)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    JOJOBA OIL (UNII: 724GKU717M)  
    Ethylhexyl Palmitate (UNII: 2865993309)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Sodium Hydroxymethylglycinate (UNII: DIG6BWZ9XT)  
    Lactic Acid (UNII: 33X04XA5AT)  
    Aluminum Oxide (UNII: LMI26O6933)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)  
    BITTER ORANGE OIL (UNII: 9TLV70SV6I)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    LIMONENE, (+/-)- (UNII: 9MC3I34447)  
    Product Characteristics
    ColorWHITE (Off-White) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68105-005-031 in 1 CARTON
    1NDC:68105-005-01100 mL in 1 BOTTLE, PUMP
    2NDC:68105-005-041 in 1 CARTON
    2NDC:68105-005-0230 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/01/2013
    Labeler - Jurlique International Pty. Ltd. (752025791)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jurlique International Pty. Ltd.752025791MANUFACTURE(68105-005)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!