Label: PREVAGE ANTI AGING SPF 30- octisalate, octinoxate, oxybenzone, avobenzone, octocrylene, 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 February 9, 2022

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  • ACTIVE INGREDIENTS

    OCTINOXATE, 7.5 %

    OCTISALATE, 5.0 %

    OXYBENZONE, 5.0 %

    OCTOCRYLENE, 2.2 %

    AVOBENZONE, 2.0 %

  • Inactive Ingredients

    WATER/AQUA/EAU, GLYCERIN, DIMETHICONE, CETEARYL ALCOHOL, PROPYLENE GLYCOL, C12-15 ALKYL BENZOATE, PEG-40 HYDROGENATED CASTOR OIL, POTASSIUM CETYL PHOSPHATE, GLYCERYL POLYACRYLATE, GLYCERYL STEARATE, BUTYROSPERMUM PARKII (SHEA) BUTTER, CARBOMER, CYCLOHEXASILOXANE, CYCLOPENTASILOXANE, ERGOTHIONEINE, HYDROGENATED PALM GLYCERIDES, HYDROXYDECYL UBIQUINOYL DIPALMITOYL GLYCERATE, MICA, PARFUM/FRAGRANCE, POLYQUATERNIUM-51, SODIUM HYALURONATE, SODIUM HYDROXIDE, SODIUM PCA, TREHALOSE, UREA, BHT, ALPHA-ISOMETHYL IONONE, LINALOOL, BENZOIC ACID, CHLORPHENESIN, METHYLPARABEN, PHENOXYETHANOL, IRON OXIDES, YELLOW (CI 77492), RED 4 (CI 14700), TITANIUM DIOXIDE (CI 77891), YELLOW 5 (CI 19140).

  • Purpose

    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 eyes. Rinse with water to remove.

    Stop using and ask a docotr is rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions For Sunscreen Use:

    Apply liberally 15 minutes before sun exposure

    Replly:

    - at least every 2 hours

    - use a water resistant sunscreen if swimming or sweating

    Sun Protection measures. Spending time in the sun increases your risk od skin cancer and warly skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF 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 sleeve shirts, pants, hats and sunglasses.

    - Children under 6 months: Ask a doctor.

  • PRINCIPAL DISPLAY PANEL

    Prevage lotion SPF

  • INGREDIENTS AND APPEARANCE
    PREVAGE ANTI AGING SPF 30 
    octisalate, octinoxate, oxybenzone, avobenzone, octocrylene, lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10967-686
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.2 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CARBOMER 1342 (UNII: 809Y72KV36)  
    DIMETHICONE 1000 (UNII: MCU2324216)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    HYDROXYDECYL UBIQUINOYL DIPALMITOYL GLYCERATE (UNII: OV1BT2N8RC)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    TREHALOSE (UNII: B8WCK70T7I)  
    HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 4:1) (UNII: X8Q92E1CPM)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    ACRYLIC ACID (UNII: J94PBK7X8S)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    ERGOTHIONEINE (UNII: BDZ3DQM98W)  
    UREA (UNII: 8W8T17847W)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    2-(4-(DIETHYLAMINO)-2-HYDROXYBENZOYL)BENZOIC ACID (UNII: X4K32L28QB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10967-686-1750 mL in 1 TUBE; Type 0: Not a Combination Product01/02/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/02/2020
    Labeler - Revlon (788820165)
    Establishment
    NameAddressID/FEIBusiness Operations
    Englewood Lab. INC.080987545manufacture(10967-686)
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