Label: SUN X MULTI-PACK SPF 30 THICK- avobenzone, homosalate, octinoxate, octisalate, oxybenzone lotion

  • 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 January 1, 2020

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  • ACTIVE INGREDIENTS

    Avobenzone 1.0%

    Homosalate 5.0%

    Octinoxate 7.5%

    Octisalate 5.0%

    Oxybenzone 6.0%

  • PURPOSE

    Sunscreen

    Sunscreen

    Sunscreen

    Sunscreen

    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
  • When using this product

    • keep out of the eyes
    • rinse with water to remove
  • Stop use and aska doctor if

    • rash occurs
  • 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
    • 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 after sun protection measures including:
    • limit time in the sun, especially from 10:00 a.m. - 2 p.m.
    • wear long-sleeved shirts, pants, hats and sunglasses.
    • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
    • children under 6 months of age: Ask a doctor
  • OTHER INFORMATION

    • protect this product from excessive heat or direct sun
  • INACTIVE INGREDIENTS

    acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, butylparaben, calendula officinalis flower extract, carbomer, chamomile recutita extract, dimethicone, dimethyl capramide, ethylparaben, fragrance, glyceryl stearate, isobutylparaben, methylparaben, nasturtium officinale extract, peg-100 stearate, phenoxyethanol, propylparaben, symphytum officinale leaf extract, tetrasodium EDTA, triethanolamine, tocopherol, tocopherol acetate, water

  • QUESTIONS?

    Call 1-877-684-5774

  • Kit Contents

    1 Towelette

  • PRINCIPAL DISPLAY PANEL

    SunX Multipack

  • INGREDIENTS AND APPEARANCE
    SUN X MULTI-PACK SPF 30 THICK 
    avobenzone, homosalate, octinoxate, octisalate, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65753-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    C12-20 ALKYL BENZOATE (UNII: Y15I6XI14C)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    NASTURTIUM OFFICINALE (UNII: YH89GMV676)  
    COMFREY LEAF (UNII: DG4F8T839X)  
    CHAMOMILE (UNII: FGL3685T2X)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65753-102-2225 in 1 CONTAINER01/01/2017
    17 g in 1 POUCH; Type 0: Not a Combination Product
    2NDC:65753-102-2325 in 1 CONTAINER01/01/2017
    27 g in 1 POUCH; Type 0: Not a Combination Product
    3NDC:65753-102-2450 in 1 CONTAINER01/01/2017
    37 g in 1 POUCH; Type 0: Not a Combination Product
    4NDC:65753-102-31150 in 1 BOX01/01/2017
    47 g in 1 POUCH; Type 0: Not a Combination Product
    5NDC:65753-102-26300 in 1 BOX01/01/2017
    57 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/01/2017
    Labeler - CoreTex Products Inc (061944620)
    Establishment
    NameAddressID/FEIBusiness Operations
    CoreTex Products Inc061944620label(65753-102)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pure Source080354456manufacture(65753-102)
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