CLEARPROOF SPOT SOLUTION FOR ACNE-PRONE SKIN- salicylic acid cream

ClearProof Spot Solution for Acne-Prone Skin by

Drug Labeling and Warnings

ClearProof Spot Solution for Acne-Prone Skin by is a Otc medication manufactured, distributed, or labeled by Mary Kay Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

This spot solution cream is formulated to target current blemishes.

Directions:

Apply directly to affected areas as needed.

Apply product sparingly to one or two small, affected areas during the first 3 days.

If no discomfort occurs, follow the directions stated above.

Warnings:

Not to be used for children under 3 years of age.

Avoid direct contact with eyes.

If product gets into eyes, rinse thoroughly with water.

INGREDIENTS:

AQUA, ETHYLHEXYL PALMITATE, STEARYL ALCOHOL, GLYCERIN, SALICYLIC ACID, TRIETHANOLAMINE,
CYCLOPENTASILOXANE, POLYSORBATE 60, PROPYLENE GLYCOL, GLYCERYL STEARATE,
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, BUTYL AVOCADATE, ETHYLENE/ACRYLIC ACID COPOLYMER, RETINYL PALMITATE, STEARETH-20, PEG-100 STEARATE, POLYACRYLATE-13, SUCROSE DISTEARATE, CETEARYL ALCOHOL, DIMETHICONE CROSSPOLYMER, SUCROSE STEARATE, POLYISOBUTENE, ARCTIUM LAPPA
ROOT EXTRACT, CITRIC ACID, DISODIUM EDTA, TITANIUM DIOXIDE/CI 77891, METHYLDIHYDROJASMONATE, C12-14
PARETH-12, EPILOBIUM ANGUSTIFOLIUM FLOWER/ LEAF/STEM EXTRACT, POLYSORBATE 20, CYCLOHEXASILOXANE, ETHYLENE BRASSYLATE, ETHYL LINALOOL, PHENOXYETHANOL, BUTYLENE GLYCOL, ISOBUTYL METHYL
TETRAHYDROPYRANOL, METHYLENEDIOXYPHENYL METHYLPROPANAL, METHYLPARABEN, CYSTOSEIRA
AMENTACEA/CAESPITOSA/BRANCHYCARPA EXTRACT, CHLORPHENESIN, GAMMA-UNDECALACTONE, BENZOIC
ACID, CYCLAMEN ALDEHYDE, SODIUM METABISULFITE, PROPYL GALLATE, CI 19140, CI 17200, CI 42090

Principal Display Panel - 29 g carton

clearproof

spot solution for acne-prone skin

29 g

INGREDIENTS AND APPEARANCE

CLEARPROOF SPOT SOLUTION FOR ACNE-PRONE SKIN 
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51531-5439
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
STEARETH-20 (UNII: L0Q8IK9E08)
.GAMMA.-UNDECALACTONE (UNII: QB1T0AG2YL)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SUCROSE STEARATE (UNII: 274KW0O50M)
BUTYL AVOCADATE (UNII: Q86RQ0D402)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PEG-100 STEARATE (UNII: YD01N1999R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
TROLAMINE (UNII: 9O3K93S3TK)
POLYSORBATE 60 (UNII: CAL22UVI4M)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y)
EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
ETHYL LINALOOL (UNII: SF2JS9GF5T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
3-(3,4-METHYLENEDIOXYPHENYL)-2-METHYLPROPANAL (UNII: L65EG8H6PA)
METHYLPARABEN (UNII: A2I8C7HI9T)
CHLORPHENESIN (UNII: I670DAL4SZ)
BENZOIC ACID (UNII: 8SKN0B0MIM)
CYCLAMEN ALDEHYDE (UNII: 4U37UX0E1E)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
WATER (UNII: 059QF0KO0R)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
SUCROSE DISTEARATE (UNII: 33X4X4B90S)
POLYISOBUTYLENE (2300 MW) (UNII: DSQ2V1DD1K)
ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S) (UNII: 1PEZ3NLY6I)
C12-14 PARETH-12 (UNII: M0LJS773XW)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
EDETATE DISODIUM (UNII: 7FLD91C86K)
2-ISOBUTYL-4-METHYLTETRAHYDROPYRAN-4-OL (UNII: VK5ZHH2T3F)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
PROPYL GALLATE (UNII: 8D4SNN7V92)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51531-5439-1	1 in 1 CARTON	11/30/2017
1		29 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		11/30/2017

Labeler - Mary Kay Inc. (049994452)

Establishment
Name	Address	ID/FEI	Business Operations
Mary Kay Inc.		103978839	manufacture(51531-5439)