Label: DAILY MOISTURIZING ANTIOXIDANT SPF 50- avobenzone, homosalate, octinoxate, octisalate cream

  • 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 October 19, 2021

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

  • Revision Multi-Protection Broad-Spectrum SPF 50

    Multi-Protection
    Broad-Spectrum
    SPF 50

    daily oil-free anti-aging
    moisturizer with sunscreen


    NET WT 1.7 OZ | 48 g

    Active ingredient          Purpose

    Avobenzone 3% ........... Sunscreen
    Homosalate 3% ............ Sunscreen
    Octinoxate 7.5% .......... Sunscreen
    Octisalate 4% ............... 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 eyes. Rinse with water to remove.

    Stop use and ask a 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 15 minutes before sun exposure
    • reapply 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 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

    Inactive ingredientsWater (Aqua), C12-15 Alkyl Ethylhexanoate, Cyclopentasiloxane, Cetearyl Alcohol, Polyglyceryl-3-Methylglucose Distearate, Boron Nitride,
    Hydrogenated Starch Hydrolysate, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Butylene Glycol, Tetrahexyldecyl Ascorbate, Yeast Extract
    (Faex), Camellia Sinensis (Green Tea) Leaf Extract, Epigallocatechin Gallate, Betula Alba (White Birch) Bark Extract, Biosaccharide Gum-1,
    Ubiquinone, Cetyl Dimethicone, Palmitoyl Tripeptide-5, Squalane, Sodium Hyaluronate, Palmitoyl Dipeptide-5 Diaminobutyroyl
    Hydroxythreonine, Punica Granatum (Pomegranate) Extract, Plankton Extract, Steareth-20, Tocopheryl Acetate, Allantoin, Lecithin,
    Tetradecyl Aminobutyroylvalylaminobutyric Urea Trifluoroacetate, Glyceryl Caprylate, Carbomer, Leuconostoc/Radish Root Ferment Filtrate,
    Tocopherol, Steareth-10, Jojoba Bean Meal, Disodium EDTA, Magnesium Chloride, Potassium Sorbate, Fragrance (Parfum).

    Other information
    • protect this product from excessive heat and direct sun

    Dist. by Revision, LP
    Irving, TX 75063 Made in U.S.A.

  • Revercel AM Moisturizing Sunscreen Broad Spectrum SPF 50

    am
    moisturizing
    sunscreen

    broad spectrum
    spf 50


    net wt. 1.7oz. | 48g

    Active ingredient          Purpose
    Avobenzone 3% ........... Sunscreen
    Homosalate 3% ............ Sunscreen
    Octinoxate 7.5% .......... Sunscreen
    Octisalate 4% ............... 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 eyes. Rinse with water to remove.

    Stop use and ask a 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 15 minutes before sun exposure
    • reapply 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 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

    Inactive ingredients
    Water (Aqua), C12-15 Alkyl Ethylhexanoate, Cyclopentasiloxane, Cetearyl Alcohol, Polyglyceryl-3-Methylglucose Distearate,
    Boron Nitride, Sorbitol, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Butylene Glycol, Tetrahexyldecyl Ascorbate, Palmitoyl
    Tripeptide-5, Glyceryl Caprylate, Leuconostoc/Radish Root Ferment Filtrate, Cetyl Dimethicone, Tocopherol, Squalane,
    Steareth-20, Jojoba Bean Meal, Allantoin, Plankton Extract, Palmitoyl Dipeptide-5 Diaminobutyroyl Hydroxythreonine, Lecithin,
    Sodium Hyaluronate, Betula Alba (White Birch) Bark Extract, Punica Granatum (Pomegranate) Extract, Yeast Extract (Faex),
    Biosaccharide Gum-1, Tocopheryl Acetate, Tetradecyl Aminobutyroylvalylaminobutyric Urea Trifluoroacetate, Epigallocatechin
    Gallate, Camellia Sinensis (Green Tea) Leaf Extract, Ubiquinone, Magnesium Chloride, Carbomer, Disodium EDTA, Steareth-10,
    Potassium Sorbate, Fragrance (Parfum)

    Other information
    • protect this product from excessive heat and direct sun

    Made in the USA
    Distributed by Revercel LLC
    Campbel, CA 95008

  • PRINCIPAL DISPLAY PANEL

    Revision Multi-Protection 1.7oz

    1.7oz MPC

    Revision Multi-Protection 8oz

    8oz MPC

    Revision Multi-Protection Sample

    3g MPC

    Revercel AM 1.7oz

    1.7oz AM

  • INGREDIENTS AND APPEARANCE
    DAILY MOISTURIZING ANTIOXIDANT SPF 50 
    avobenzone, homosalate, octinoxate, octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10477-7720
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE3 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    YEAST (UNII: 3NY3SM6B8U)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    EPIGALLOCATECHIN GALLATE (UNII: BQM438CTEL)  
    BETULA PUBESCENS BARK (UNII: 3R504894L9)  
    BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
    UBIDECARENONE (UNII: EJ27X76M46)  
    CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
    PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO)  
    SQUALANE (UNII: GW89575KF9)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    PALMITOYLLYSYLVALYLDIAMINOBUTYROYLTHREONINE (UNII: 1615WE9073)  
    POMEGRANATE (UNII: 56687D1Z4D)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALLANTOIN (UNII: 344S277G0Z)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    STEARETH-10 (UNII: FD0913P475)  
    SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10477-7720-11 in 1 CARTON06/26/2013
    148 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:10477-7720-2227 g in 1 TUBE; Type 0: Not a Combination Product06/26/2013
    3NDC:10477-7720-33 g in 1 TUBE; Type 0: Not a Combination Product06/26/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/26/2013
    Labeler - Goodier Cosmetics LLC (007317209)
    Registrant - Goodier Cosmetics LLC (007317209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Goodier Cosmetics LLC007317209manufacture(10477-7720)