Label: OCTISALATE, AVOBENZONE, HOMOSALATE, OCTOCRYLENE SPF30- julep solace oil-free sunscreen broad spectrum lotion

  • NDC Code(s): 76280-231-01, 76280-231-02
  • Packager: Julep Nail Parlor
  • 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 24, 2019

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

  • Active Ingredients

    Avobenzone 3.0%

    Homosalate 5.0%

    Octisalate 5.0%

    Octocrylene 2.7%

    Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn
    • 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

    Do not use

    on damaged or broken skin

    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
    • reapply:
    • after 40 minutes of swimming or sweating
    • immediately after towel drying
    • 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 this risk, regularly use a sunscreen with a broad spectrum SPF value 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-sleeved shirts,pants, hats, and sunglasses
    • Children under 6 months: Ask a doctor
  • Other Information

    Protect this product from excessive heat and direct sun

  • Questions or Comments?

    Call toll free 1-877-585-3707

  • Inactive Ingredients

    ALOE BARBADENSIS (ALOE LEAF JUICE), ALOE BARBADENSIS LEAF EXTRACT, AMINOMETHYL PROPANOL, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, BUTYLENE GLYCOL, CAPRYLYL GLYCOL, CEATEARYL ALCOHOL, CHLORPHENESIN,  CITRUS SINENSIS (BLOOD ORANGE) FRUIT EXTRACT, COCO CAPRYLATE/CAPRATE, DECYL GLUCOSIDE, DEXTRIN, DIMETHICONE, DISODIUM EDTA, ETHYLHEXYL STEARATE, FRAGRANCE/PARFUM, GLYCERIN, GLYCERYL STEARATE, HYDROLYZED HIBISCUS ESCULENTUS EXTRACT, ISODODECANE, PEG-100 STEARATE, PENTYLENE GLYCOL, PHENOXYETHANOL, POLYSILICONE-II, POLYURETHANE-34, SODIUM CITRATE, SODIUM POLYACRYLATE, TAPIOCA STARCH POLYMETHYLSILSESQUIOXANE, TOCOPHERYL ACETATE, TRIDECETH 6, WATER/EAU, XANTHAN GUM

  • PRINCIPAL DISPLAY PANEL

    SolaceUC

  • INGREDIENTS AND APPEARANCE
    OCTISALATE, AVOBENZONE, HOMOSALATE, OCTOCRYLENE  SPF30
    julep solace oil-free sunscreen broad spectrum lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76280-231
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 89 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 89 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5 g  in 89 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.7 g  in 89 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    CITRUS SINENSIS FRUIT OIL (UNII: WV48LBL15Q)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    icodextrin (UNII: 2NX48Z0A9G)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ABELMOSCHUS ESCULENTUS SEED (UNII: 1GJ68JL4J5)  
    ISODODECANE (UNII: A8289P68Y2)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSILICONE-15 (UNII: F8DRP5BB29)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    STARCH, TAPIOCA (UNII: 24SC3U704I)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    TRIDECETH-6 (UNII: 3T5PCR2H0C)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76280-231-021 in 1 CARTON10/01/2013
    1NDC:76280-231-0189 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/01/2013
    Labeler - Julep Nail Parlor (023413483)