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

Helps reduce and prevent blackheads and pimples.

Directions:

On clean skin, apply once a day only to affected areas.

In the first week, use a small amount once a day on alternate days.

Increase to up to 3 times a day if necessary.

If irritation occurs or your skin feels more sensitive, reduce applications.

Warnings:

For external use only.

Not to be used on children.

Do not apply to the eyelids, the edges of the nose and mouth, or to irritated or damaged slin.

Avoid the eye area.

For use during pregnancy, consult your doctor.

Avoid sun exposure when using this product.

In the first applications, you may experience a transient burning sensation or itchy or dry skin.

If the discomfort persists, discontinue use of the product and consult your doctor.

Keep out of the reach of children. Do not ingest

In case of accidental contact with the eyes, rinse thoroughly with water.

If irritation develops, discontinue use and consult your doctor.

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: 51531-8953
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
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SUCROSE STEARATE (UNII: 274KW0O50M)
BUTYL AVOCADATE (UNII: Q86RQ0D402)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
STEARETH-20 (UNII: L0Q8IK9E08)
.GAMMA.-UNDECALACTONE (UNII: QB1T0AG2YL)
GLYCERIN (UNII: PDC6A3C0OX)
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: 51531-8953-1	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(51531-8953)