FDA.reportPublic FDA data

ClearProof Spot Solution for Acne-Prone Skin

Manufacturer
Mary Kay Inc.
Effective date
2020-06-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:34:47

Label at a glance#

ProductClearProof Spot Solution for Acne-Prone Skin
Active ingredientSALICYLIC ACID
Label structure5 sections

Dosage and administration

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.

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

This spot solution cream is formulated to target current blemishes.

Directions:

DOSAGE & ADMINISTRATION SECTION

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:

WARNINGS AND PRECAUTIONS SECTION

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:

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

clearproof

spot solution for acne-prone skin

29 g

image of EU export cartonimage of EU export carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
317152salicylic acid 2 % Topical CreamPSN1
317152salicylic acid 20 MG/ML Topical CreamSCD1
317152salicylic acid 2 % Topical CreamSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51531-5439-1ClearProof Spot Solution for Acne-Prone Skin1 in 1 CARTONCREAM11
51531-5439-1ClearProof Spot Solution for Acne-Prone Skin29 g in 1 TUBECREAM291

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51531-5439CLEARPROOF SPOT SOLUTION FOR ACNE-PRONE SKIN (SALICYLIC ACID) CREAM [MARY KAY INC.]12 package rows20201209_a8db2fdb-00c9-0be7-e053-2a95a90aab0c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 47 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51531-543951531-5439-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 46 matching rows.

Name, UNII, Kind table
NameUNIIKind
VITAMIN A PALMITATE1D1K0N0VVCIACT
STEARETH-20L0Q8IK9E08IACT
.GAMMA.-UNDECALACTONEQB1T0AG2YLIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SUCROSE STEARATE274KW0O50MIACT
BUTYL AVOCADATEQ86RQ0D402IACT
POLYSORBATE 207T1F30V5YHIACT
PEG-100 STEARATEYD01N1999RIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)UF7620L1W6IACT
ARCTIUM LAPPA ROOT597E9BI3Z3IACT
ETHYLENE BRASSYLATE9A87HC7RODIACT
SALICYLIC ACIDO414PZ4LPZACTIB
ETHYLHEXYL PALMITATE2865993309IACT
TROLAMINE9O3K93S3TKIACT
POLYSORBATE 60CAL22UVI4MIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
METHYL DIHYDROJASMONATE (SYNTHETIC)3GW44CIE3YIACT
EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP08H094218DIACT
CYCLOMETHICONE 6XHK3U310BAIACT
ETHYL LINALOOLSF2JS9GF5TIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
3-(3,4-METHYLENEDIOXYPHENYL)-2-METHYLPROPANALL65EG8H6PAIACT
METHYLPARABENA2I8C7HI9TIACT
CHLORPHENESINI670DAL4SZIACT
BENZOIC ACID8SKN0B0MIMIACT
CYCLAMEN ALDEHYDE4U37UX0E1EIACT
D&C RED NO. 339DBA0SBB0LIACT
WATER059QF0KO0RIACT
STEARYL ALCOHOL2KR89I4H1YIACT
CYCLOMETHICONE 50THT5PCI0RIACT
SUCROSE DISTEARATE33X4X4B90SIACT
POLYISOBUTYLENE (2300 MW)DSQ2V1DD1KIACT
ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S)1PEZ3NLY6IIACT
C12-14 PARETH-12M0LJS773XWIACT
PHENOXYETHANOLHIE492ZZ3TIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a8db2fdb-00ca-0be7-e053-2a95a90aab0ca8db2fdb-00c9-0be7-e053-2a95a90aab0c2020-06-24WarningsExact identifier
spl id: a8db2fdb-00ca-0be7-e053-2a95a90aab0c
spl set id: a8db2fdb-00c9-0be7-e053-2a95a90aab0c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.