Label: SUGAR BLOOM TINTED TREATMENT SUNSCREEN SPF 15- octinoxate paste

  • 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 June 4, 2018

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

  • Drug Facts
  • Active Ingredients

    Octinoxate 6.74%

    Purpose

    Sunscreen

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  • Use

    Helps prevent sunburn

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  • 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.

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  • Directions

    For sunscreen use:
    • 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

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  • Other Information

    Protect this product in container from excessive heat and direct sun

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  • Questions or Comments?

    Call toll free 1(800)FRESH-20 Monday-Friday (9 a.m. to 5p.m EST)

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  • Inactive Ingredients

    Cera Alba (Beeswax), Ricinus Communis (Castor) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Hydrogenated Olive Oil Decyl Esters, Vitis Vinifera (Grape) Seed Oil, Parfum (Fragrance), Synthetic Fluorphlogopite, Copernicia Cerifera (Carnauba) Wax, Persea Gratissima (Avocado) Oil, Limnanthes Alba (Meadowfoam) Seed Oil, Passiflora Incarnata Seed Oil, Sucrose Tetrastearate Triacetate, Ribes Nigrum (Black Currant) Seed Oil, Tocopherol, Ascorbyl Tetraisopalmitate, Ascorbyl Palmitate, Ammonium Glycyrrhizate, Polyglyceryl- 3 Polyricinoleate, Vanillin, BHT, Propyl Gallate, Limonene, Citral, Benzyl Alcohol, Linalool, Geraniol [May Contain: CI 15850 (Red 6, Red 7, Red 7 Lake), CI 15985 (Yellow 6, Yellow 6 Lake), CI 19140 (Yellow 5, Yellow 5 Lake), CI 42090 (Blue 1 Lake), CI 45410 (Red 27, Red 27 Lake, Red 28 Lake), CI 77491, CI 77492, CI 77499 (Iron Oxides), CI 77891 (Titanium Dioxide)] <12339/Z>

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  • Package Labeling:
  • INGREDIENTS AND APPEARANCE
    SUGAR BLOOM TINTED TREATMENT SUNSCREEN SPF 15 
    octinoxate paste
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:42406-044
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 67.4 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    JOJOBA OIL (UNII: 724GKU717M)  
    HYDROGENATED OLIVE OIL DECYL ESTERS (UNII: XQ691JJ99N)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
    PASSIFLORA INCARNATA SEED OIL (UNII: S0SU5AC95J)  
    SUCROSE TETRASTEARATE TRIACETATE (UNII: 1K7LBQ045N)  
    RIBES NIGRUM SEED OIL (UNII: GKE1188837)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    VANILLIN (UNII: CHI530446X)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    CITRAL (UNII: T7EU0O9VPP)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    GERANIOL (UNII: L837108USY)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42406-044-01 1 in 1 CARTON 11/01/2018
    1 4.3 g in 1 BOX; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 11/01/2018
    Labeler - Fresh Inc (021403729)
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