Label: CLEAR REFLECTION COMPLEXION- salicylic acid kit
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Contains inactivated NDC Code(s)
NDC Code(s): 76348-691-01, 76348-692-02, 76348-693-04, 76348-694-55, view more76348-710-01 - Packager: RENU LABORATORIES, INC.
- 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.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient:
- Warnings
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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.
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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.
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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.
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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.
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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
- INDICATIONS & USAGE
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CLEAR REFLECTION COMPLEXION
salicylic acid kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76348-710 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76348-710-01 1 in 1 BOX; Type 0: Not a Combination Product 07/01/2021 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 0 BOTTLE, PLASTIC 1 g in 112 Part 2 0 BOTTLE, PUMP 1.1 g in 53 Part 3 0 BOTTLE, PUMP 1 g in 112 Part 4 0 BOTTLE, PUMP 1 g in 52 Part 1 of 4 CLEAR REFLECTION COMPLEXION PORE REFININGTONER
salicylic acid toner liquidProduct Information Item Code (Source) NDC:76348-693 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 0.56 g in 112 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:76348-693-04 112 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 07/01/2021 Part 2 of 4 CLEAR REFLECTION COMPLEXION REHYDRATING EMULSION
salicylic acid emulsion emulsionProduct Information Item Code (Source) NDC:76348-694 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 1 g in 53 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:76348-694-55 53 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 07/01/2021 Part 3 of 4 CLEAR REFLECTION COMPLEXION FOAMING CLEANSER
salicylic acid soapProduct Information Item Code (Source) NDC:76348-691 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 0.56 g in 112 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:76348-691-01 112 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 08/19/2021 Part 4 of 4 CLEAR REFLECTION COMPLEXION SERUM
salicylic acid 0.5% serum liquidProduct Information Item Code (Source) NDC:76348-692 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 1 g in 50 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:76348-692-02 52 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 07/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 07/01/2021 Labeler - RENU LABORATORIES, INC. (945739449) Establishment Name Address ID/FEI Business Operations RENU LABORATORIES, INC. 945739449 manufacture(76348-710)