Label: STILA HYDRATING PRIMER OIL-FREE SPF 30 (ALL SHADES)- avobenzone, octisalate, and octinoxate lotion

  • 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 18, 2013

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  • Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients Purpose
      Avobenzone3.00% sunscreen
      Octisalate5.00% sunscreen
      Octinoxate7.50% sunscreen
  • Uses

    Provides moderate protection against sunburn.

  • Sun Alert

    The sun may cause sunburn, premature aging of the skin, and skin cancer. Avoiding the sun, wearing protective clothing, and regular use of sunscreens over the years may reduce the chance of harmful effects.

  • Warnings

    For external use only.

    When using this product

    Keep out of eyes.

    Stop use and see a doctor if

    Irritation occurs.

    Keep out of reach of children.

    Do not use on infants under 6 months old.

  • Directions

    Blend over entire face with fingertips.

  • Inactive Ingredients

    water (aqua), octyldodecyl neopentanoate, c12-15 alkyl benzoate, propylene glycol, cetearyl alcohol, butyrospermum parkii (shea) butter, butylene glycol, coco-glucoside, persea gratissima(avocado) oil, squalane, corylus avellana (hazel) seed oil, simmondsia chinensis (jojoba) seed oil, tocopheyl acetate, ascorbyl palmitate, glyceryl stearate, behenyl alcohol, palmitic acid, stearic acid, lecithin, lauryl alcohol, myristyl alcohol, cetyl alcohol, bisabolol, centella asiatica extract, echinacea purpurea extract, algae extract, panax ginseng (ginseng) root extract, sodium hyaluronate, pentylene glycol, glycerin, sodium lactate, lactic acid, serine, urea, sorbitol, sodium chloride, allantoin, cucumis sativus (cucumber) oil, carbomer, microcrystalline cellulose, dimethicone, sodium hydroxide, disodium edta, phenoxyethanol, o-cymen-5-ol, ethylhexylglycerin, may contain (+/-): red 4 (ci 14700) <iln c111008>.

  • SPL UNCLASSIFIED SECTION

    dist. by © stila styles, llc
    los angeles, ca 90027

  • PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton

    stila

    hydrating primer
    oil-free
    SPF 30

    1.7 fl. oz./50 ml

    Principal Display Panel - 50 ml Tube Carton
  • INGREDIENTS AND APPEARANCE
    STILA HYDRATING PRIMER OIL-FREE SPF 30   (ALL SHADES)
    avobenzone, octisalate, and octinoxate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76049-715
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone3 mg  in 1 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate5 mg  in 1 mL
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate7.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    octyldodecyl neopentanoate (UNII: X8725R883T)  
    alkyl (c12-15) benzoate (UNII: A9EJ3J61HQ)  
    propylene glycol (UNII: 6DC9Q167V3)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    shea butter (UNII: K49155WL9Y)  
    butylene glycol (UNII: 3XUS85K0RA)  
    coco glucoside (UNII: ICS790225B)  
    avocado oil (UNII: 6VNO72PFC1)  
    squalane (UNII: GW89575KF9)  
    european hazelnut oil (UNII: 8RQ2839AVG)  
    jojoba oil (UNII: 724GKU717M)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    ascorbyl palmitate (UNII: QN83US2B0N)  
    glyceryl monostearate (UNII: 230OU9XXE4)  
    docosanol (UNII: 9G1OE216XY)  
    palmitic acid (UNII: 2V16EO95H1)  
    stearic acid (UNII: 4ELV7Z65AP)  
    lauryl alcohol (UNII: 178A96NLP2)  
    myristyl alcohol (UNII: V42034O9PU)  
    cetyl alcohol (UNII: 936JST6JCN)  
    levomenol (UNII: 24WE03BX2T)  
    centella asiatica (UNII: 7M867G6T1U)  
    echinacea purpurea (UNII: QI7G114Y98)  
    asian ginseng (UNII: CUQ3A77YXI)  
    hyaluronate sodium (UNII: YSE9PPT4TH)  
    pentylene glycol (UNII: 50C1307PZG)  
    glycerin (UNII: PDC6A3C0OX)  
    sodium lactate (UNII: TU7HW0W0QT)  
    lactic acid (UNII: 33X04XA5AT)  
    serine (UNII: 452VLY9402)  
    urea (UNII: 8W8T17847W)  
    sorbitol (UNII: 506T60A25R)  
    sodium chloride (UNII: 451W47IQ8X)  
    allantoin (UNII: 344S277G0Z)  
    cucumber seed oil (UNII: AKP926H71P)  
    cellulose, microcrystalline (UNII: OP1R32D61U)  
    dimethicone (UNII: 92RU3N3Y1O)  
    sodium hydroxide (UNII: 55X04QC32I)  
    edetate disodium (UNII: 7FLD91C86K)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    o-cymen-5-ol (UNII: H41B6Q1I9L)  
    ethylhexylglycerin (UNII: 147D247K3P)  
    fd&c red no. 4 (UNII: X3W0AM1JLX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76049-715-011 in 1 CARTON
    150 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35208/30/2013
    Labeler - Stila Styles, LLC (809192896)
    Establishment
    NameAddressID/FEIBusiness Operations
    MANA PRODUCTS078870292MANUFACTURE(76049-715)
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