Label: REVERSE BRIGHTENING DEFENSE FLUID- avobenzone, homosalate, octocrylene, octisalate 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 March 10, 2021

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

  • Active Ingredients

    Avobenzone 2.8%,
    Homosalate 9.3%,
    Octisalate 4.67%,
    Octocrylene 6.1 %

  • Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn.
    • When 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 doctor if

    • rash occurs.

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

  • Directions

    • Every AM, apply liberally and evenly over face + neck 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 AM-2 PM.
      • Wear long-sleeve shirts, pants, hats and sunglasses.
    • Children under 6 months:
      Ask a doctor.
  • Inactive ingredients

    Adenosine, Aminomethyl Propanol, Aqua/Eau/Water, Benzyl Alcohol, Butylene Glycol, C12-15 Alkyl Benzoate, Calcium Gluconate, Citral, Citric Acid, Cynara Scolymus (Artichoke) Leaf Extract, Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Dipotassium Glycyrrhizate, Fragrance/Parfum, Gluconolactone, Glycerin, Hydrogenated Lecithin, Limonene, Linalool, Methyl Carboxymethylphenyl Aminocarboxypropylphosphonate, Phenoxyethanol, Propanediol, Rosmarinic Acid, Rutin, Sesamum Indicum (Sesame) Seed Extract, Silica, Sodium Benzoate, Sodium Carbomer, Titanium Dioxide (Cl 77891), Tocopherol, Xanthan Gum.

  • Other Information

    Protect this product from excessive heat and direct sun.

  • Questions?

    1-888-995-5656

  • Principal Display Panel - 30 mL Carton Label

    RODAN+FIELDS

    REVERSE

    Brightening Defense
    Fluid Lotion

    Broad Spectrum SPF 50

    3AM

    30 mL/1. Fl. Oz. U.S.

    Principal Display Panel - 30 mL Carton Label
  • Principal Display Panel - 30 mL Tube Label

    RODAN+FIELDS

    REVERSE

    Brightening Defense Fluid Lotion

    Broad Spectrum SPF 50

    3AM

    Principal Display Panel - 30 mL Tube Label
  • INGREDIENTS AND APPEARANCE
    REVERSE BRIGHTENING DEFENSE FLUID 
    avobenzone, homosalate, octocrylene, octisalate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14222-2300
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.028 g  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE0.093 g  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.061 g  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.0467 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ADENOSINE (UNII: K72T3FS567)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CALCIUM GLUCONATE (UNII: SQE6VB453K)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    CITRAL (UNII: T7EU0O9VPP)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CYNARA SCOLYMUS LEAF (UNII: B71UA545DE)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    ROSMARINIC ACID (UNII: MQE6XG29YI)  
    RUTIN (UNII: 5G06TVY3R7)  
    SESAME SEED (UNII: 7Y1255HVXR)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14222-2300-11 in 1 CARTON03/09/2021
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/09/2021
    Labeler - Rodan & Fields (051659584)