Label: CLEAR REFLECTION COMPLEXION- salicylic acid kit

  • 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 August 19, 2021

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

  • Active Ingredient:

    Salicylic Acid 0.5 percent

    PART 1 - CLEAR REFLECTION FOAMING CLEANSER

    Salicylic Acid

    0.5 percent

    PART 2 - CLEAR REFLECTION COMPLEXION ACNE TREATMENT SERUM

    2 percent Salicylic Acid

    PART 3 - CLEAR REFLECTION COMPLEXION Pore Refining Toner

    Active Ingredient

    Salicylic Acid

    PART 4 - CLEAR REFLECTION COMPLEXION Topical Rehydrating Emulsion

    Active Ingredient

    Salicylic Acid

  • Warnings

    For external use only

    PART 1 CLEANSER WARNING

    For external use only.

    PART 2 - ACNE TREATMENT SERUM Warnings:

    For external use only.

    PART 3 - CLEAR REFLECTION COMPLEXION Pore Refining Toner

    For external use only.

    PART 4

    For external use only

  • DO NOT USE

    Do not use this medication if you have very sensitive skin or if you are sensitive to salicylic acid.

    PART 1 CLEANSER

    Do not use this medication if you have very sensitive skin or if you are sensitive to salicylic acid.

    PART 2 - ACNE TREATMENT SERUM

    Do not use this medication if you have very sensitive skin or if you are sensitive to salicylic acid.

    PART 3 - CLEAR REFLECTION COMPLEXION Pore Refining Toner

    Do not use this medication if you have very sensitive skin or if you are sensitive to salicylic acid.

    PART 4 - Clear Reflection COMPLEXION Topical Rehydrating Emulsion

    Do not use this medication if you have very sensitive skin or if you are sensitive to salicylic acid.

  • WHEN USING

    When using this product

    • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
    • avoid contact with eyes.
    • If contact occurs, rinse thoroughly with water.

    PART 2 - ACNE TREATMENT SERUM

    Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time

    • avoid contact with eyes
    • If contact occurs, rinse thoroughly with water.

    PART 3 - Pore Refining Toner

    When using this product

    • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time
    • avoid contact with eyes
    • if contact occurs, rinse thoroughly with water.

    PART 4 - Topical Rehydrating Emulsion

    PART 1

    When using this product

    skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs only use one topical acne medication at a time

    avoid contact with eyes

    if contact occurs rinse thoroughly with water

  • KEEP OUT OF REACH OF CHILDREN

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

    PART 3 - Pore Refining Toner

    Keep out of reach of children.

    If swallowed get medical help or contact a Poison Control Center right away.

    Part 4 - Topical Rehydrating Emulsion

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

    PART 1

    Keep out of reach of children

    If swallowed get medical help or contact a Poison Control Center right away

    PART 2

    Keep out of reach of children.

    If swallowed get medical help or contact a Poison Control Center right away.

  • Directions

    PART 1 - FOAMING CLEANSER - DIRECTIONS

    Use in the morning and evening. Wet face. Gently massage 1-2 pumps of foaming cleanser all over face, avoiding eye area.

    PART 3 - Pore Refining Toner

    Directions

    In the evening, apply toner to dry face with cotton pad to gently lift away dirt and impurities. Avoid the eye area. This product contains alcohol that can be drying to the skin. Those with drier skin may opt to use this product every other day to prevent excess drying.

    PART 4 - Topical Rehydrating Emulsion

    Recommended use is at nightime after cleansing skin with Clear Reflection Complexion Foaming Cleanser.

    PART 2

    Directions

    In the morning, after cleansing face, apply serum evenly and make sure all problem areas are treated. Mild tingling may occur. If bothersome dryness or peeling occurs, reduce application to once every other day.

  • Inactive Ingredients

    Aqua (Water), Decyl Glucoside, Sodium C14-16 Olefin Sulfonate, Glycerin, Sodium Cocoyl Isethionate, Butylene Glycol, PEG-7 Glyceryl Cocoate, Sodium PCA, Disodium EDTA, PEG-5m, Caprylyl Glycol, Cinnamal, Dihydroeugenol, Ethylhexylglycerin, Hexylene Glycol, Phenoxyethanol, Sodium Hydroxide.

    PART 1 - FOAMING CLEANSER INACTIVES

    Aqua (Water), Decyl Glucoside, Sodium C14-16 Olefin Sulfonate, Glycerin, Sodium Cocoyl Isethionate, Butylene Glycol, PEG-7 Glyceryl Cocoate, Sodium PCA, Disodium EDTA, PEG-5M, Caprylyl Glycol, Cinnamal, Dihydroeugenol, Ethylhexylglycerin, Hexylene Glycol, Phenoxyethanol, Sodium Hydroxide.

    PART 2 - ACNE TREATMENT SERUM

    Cyclopentasiloxane, Dimethiconol, Isopropyl Alcohol, Octyldodecanol, Helianthus Annuus (Sunflower) Seed Oil, Dimethicone, Dihydroeugenol, Isoeugenyl Acetate, Cinnamal, Ethyl Vanillin.

    PART 3 - Pore Refining Toner

    Isopropyl Alcohol, Aqua (Water), Hamamelis Virginiana (Witch Hazel), Glycerin, Butylene Glycol, Sodium PCA, Benzoic Acid, Camphor, Citric Acid, Dihydroeugenol, Isoeugenyl Acetate, Peppermint Oil, Cinnamal, Yellow 5 (CI 19140), Blue 1 (CI 42090).

    PART 4 - Topical Rehydrating Emulsion

    Inactive Ingredients:

    Aqua (Water), Stearic Acid, Propylene Glycol, Sodium Hydroxide, Citric Acid, Glycol Stearate, Squalane, Steareth-2, Steareth-21, PPG-12/SMDI Copolymer, Dihydroeugenol, Glyceryl Stearate, PEG-100 Stearate, Ceteareth-20, Cetearyl Alcohol, Bisabolol, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Caprylyl Glycol, Carbomer, Cinnamal, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Hexylene Glycol, Hydroxypropyl Starch Phosphate, Isoeugenyl Acetate, Niacinamide, Phenoxyethanol, Polysorbate 20, Potassium Lactate.

  • PURPOSE

    Acne Treatment

    PART 2 - Acne Treatment Serum

    Purpose: Acne Treatment

    PART 4

    Purpose

    Acne Treatment

    PART 3

    Purpose

    Acne Treatment

    PART 1

    Acne Treatment

  • INDICATIONS & USAGE

    see individual parts

    PART 1
    FOAMING CLEANSER

    Use cleanser morning and evening

    PART 2
    ACNE TREATMENT SERUM

    Recommended use is in the morning after cleansing and before applying any makeup.

    part 3
    Pore Refining Toner

    For regular and oil-prone skin use at least 3 times a week in the evening after cleansing skin.

    PART 4
    Topical Rehydrating Emulsion

    Recommended use is at nightime after cleansing

  • QUESTIONS

    Call Customer Service at 1 800 990 6552 or contact customerservice@dermamedics.com

  • PRINCIPAL DISPLAY PANEL

    KIT ART CLEAR REFLECTIONART FOR ENTIRE 4 PART KIT

    PART 1 - CLEAR REFLECTION COMPLEXION FOAMING CLEANSER

    subsection art CLEANSER

    PART 2 - ACNE TREATMENT SERUM

    PART 2 - SERUM IMAGE

    PART 4 - CLEAR REFLECTION TOPICAL REHYDRATING EMULSION

    PART 4 - CLEAR REFLECTION TOPICAL REHYDRATING EMULSION

    EMULSION SCREENPRINT

    PART 3

    PART 3 - TONER PACKAGE

  • INGREDIENTS AND APPEARANCE
    CLEAR REFLECTION COMPLEXION 
    salicylic acid kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-710
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76348-710-011 in 1 BOX; Type 0: Not a Combination Product07/01/2021
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 10 BOTTLE, PLASTIC 1 g  in 112 
    Part 20 BOTTLE, PUMP 1.1 g  in 53 
    Part 30 BOTTLE, PUMP 1 g  in 112 
    Part 40 BOTTLE, PUMP 1 g  in 52 
    Part 1 of 4
    CLEAR REFLECTION COMPLEXION PORE REFININGTONER 
    salicylic acid toner liquid
    Product Information
    Item Code (Source)NDC:76348-693
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.56 g  in 112 g
    Inactive Ingredients
    Ingredient NameStrength
    DIHYDROEUGENOL (UNII: A3XE712277)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    ISOEUGENYL ACETATE (UNII: 9DF21GI8W6)  
    CINNAMALDEHYDE (UNII: SR60A3XG0F)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76348-693-04112 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D07/01/2021
    Part 2 of 4
    CLEAR REFLECTION COMPLEXION REHYDRATING EMULSION 
    salicylic acid emulsion emulsion
    Product Information
    Item Code (Source)NDC:76348-694
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1 g  in 53 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
    STEARETH-21 (UNII: 53J3F32P58)  
    HYDROXYPROPYL CORN AMYLOPECTIN, PHOSPHATE CROSSLINKED (4000 MPA.S AT 5%) (UNII: GSS77345H7)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DIHYDROEUGENOL (UNII: A3XE712277)  
    ISOEUGENYL ACETATE (UNII: 9DF21GI8W6)  
    CINNAMALDEHYDE (UNII: SR60A3XG0F)  
    DIMETHICONE 500 (UNII: 5L1VVC3K8O)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    SQUALANE (UNII: GW89575KF9)  
    STEARETH-2 (UNII: V56DFE46J5)  
    PPG-12/SMDI COPOLYMER (UNII: 1BK9DDD24E)  
    POTASSIUM LACTATE, DL- (UNII: 276897E67U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    POLYETHYLENE GLYCOL 4500 (UNII: TVH7653921)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76348-694-5553 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D07/01/2021
    Part 3 of 4
    CLEAR REFLECTION COMPLEXION FOAMING CLEANSER 
    salicylic acid soap
    Product Information
    Item Code (Source)NDC:76348-691
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.56 g  in 112 g
    Inactive Ingredients
    Ingredient NameStrength
    DIHYDROEUGENOL (UNII: A3XE712277)  
    CINNAMALDEHYDE (UNII: SR60A3XG0F)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    POLYETHYLENE OXIDE 200000 (UNII: 11628IH70O)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76348-691-01112 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D08/19/2021
    Part 4 of 4
    CLEAR REFLECTION COMPLEXION SERUM 
    salicylic acid 0.5% serum liquid
    Product Information
    Item Code (Source)NDC:76348-692
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1 g  in 50 g
    Inactive Ingredients
    Ingredient NameStrength
    ETHYL VANILLIN (UNII: YC9ST449YJ)  
    ISOEUGENYL ACETATE (UNII: 9DF21GI8W6)  
    CINNAMALDEHYDE (UNII: SR60A3XG0F)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE 12500 (UNII: D1R3R4B8M8)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    DIHYDROEUGENOL (UNII: A3XE712277)  
    DIMETHICONOL (50000 CST) (UNII: R2285D73YT)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76348-692-0252 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D07/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D07/01/2021
    Labeler - RENU LABORATORIES, INC. (945739449)
    Establishment
    NameAddressID/FEIBusiness Operations
    RENU LABORATORIES, INC.945739449manufacture(76348-710)