Label: LIP TREATMENT DUO LIP SCRUB AND LIP BALM SUNSCREEN SPF 15- octinoxate, oxybenzone kit

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 October 31, 2019

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

  • Drug Facts

  • Active ingredients

    Octinoxate 7.5%

    Oxybenzone 3.0%

  • 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 to only 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

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

  • Directions

    • apply liberally and evenly 15 minutes before sun exposure. • Use a water resistant sunscreen if swimming or sweating • reapply
    at least every 2 hours • Children under 6 months of age: Ask a doctor

  • Inactive ingredients

    Diisostearyl Malate, Beeswax, Coco-Caprylate/Caprate, Polyhydroxystearic Acid, Euphorbia Cerifera (Candelilla) Wax, Citrus Sinensis (Sweet Orange) Peel Oil, Natural Flavor, Tocopherol (Vitamin E), Ascorbyl Palmitate, Simmondsia Chinensis (Jojoba) Seed Oil, Punica Granatum (Pomegranate) Sterols, Olea Europaea (Olive) Oil Unsaponifiables, Butyrosperum Parkii (Shea) Butter, Macadamia Ternfolia Seed Oil, Persea Gratissima (Avocado) Oil, Phytosterols, Olea Europaea (Olive) Fruit Oil.

  • Other information 

    • Protect this product from excessive heat and direct sun • may stain some fabrics

  • Questions or comments?

    1- 626-599-3700 Monday – Friday 9 AM – 5 PM PST

  • SPL UNCLASSIFIED SECTION

    Lip treatment duo

    LIP SCRUB & LIP BALM SUNSCREEN SPF 15

    with Jojoba Oil, Shea Butter and Macadamia Oil

    Exfoliate & Hydrate

    LIP SUGAR SCRUB

    INGREDIENTS:Sugar (Sucrose), Coco-Caprylate/Caprate, Beeswax, Polyhydroxystearic Acid, Citrus Sinensis (Sweet Orange) Peel Oil, Euphorbia Cerifera (Candelilla) Wax, Natural Flavor, Tocopherol (Vitamin E), Ascorbyl Palmitate, Simmondsia Chinensis (Jojoba) Seed Oil, Punica Granatum (Pomegranate) Sterols, Olea Europaea (Olive) Oil Unsaponifiables, Butyrospermum Parkii (Shea) Butter, Macadamia Ternifolia Seed Oil, Olea Europaea (Olive) Fruit Oil.

    Directions for use: Sugar Scrub: gently massage sugar scrub on lips, then tissue off. Use up to 3 times per week. Lip Balm: For sunscreen use see Drug Facts Panel. For all other uses, smooth on balm anytime lips need moisture.

    DIST. & SOLD EXCLUSIVELY BY: TRADER JOE’S,
    800 S. SHAMROCK AVE., MONROVIA, CA 91016

    NOT FOR INDIVIDUAL SALE.

    Trader Joe's Lip Treatment Duo is exactly what you need for soft, smooth lips. A gentle sugar scrub helps buff away dry skin, while a replenishing lip balm, formulated with Jojoba Oil, Shea Butter and Macadamia Oil, works to revive and soften even the driest of lips.

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    LIP TREATMENT DUO LIP SCRUB AND LIP BALM SUNSCREEN SPF 15 
    octinoxate, oxybenzone kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71270-612
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71270-612-551 in 1 BOX; Type 0: Not a Combination Product08/08/2017
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 7 g
    Part 21 TUBE 7 g
    Part 1 of 2
    LIP BALM SUNSCREEN SPF 15 
    octinoxate, oxybenzone ointment
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE3.0 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    JOJOBA OIL (UNII: 724GKU717M)  
    POMEGRANATE SEED OIL (UNII: 0UI45XV0T6)  
    OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    Product Characteristics
    Coloryellow (Yellowish) Score    
    ShapeSize
    FlavorVANILLA, ORANGEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    17 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart352
    Part 2 of 2
    LIP SCRUB 
    other skin care preparations
    Product Information
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRSUCROSE (UNII: C151H8M554)  
    INGRCOCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    INGRYELLOW WAX (UNII: 2ZA36H0S2V)  
    INGRPOLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    INGRORANGE OIL (UNII: AKN3KSD11B)  
    INGRCANDELILLA WAX (UNII: WL0328HX19)  
    INGR.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    INGRASCORBYL PALMITATE (UNII: QN83US2B0N)  
    INGRJOJOBA OIL (UNII: 724GKU717M)  
    INGRPOMEGRANATE SEED OIL (UNII: 0UI45XV0T6)  
    INGROLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)  
    INGRSHEA BUTTER (UNII: K49155WL9Y)  
    INGRMACADAMIA OIL (UNII: 515610SU8C)  
    INGROLIVE OIL (UNII: 6UYK2W1W1E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    17 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/08/2017
    Labeler - Trader Joe's Company (006226666)