SEBOBALANCE Purifying Sebo-absorbing Mask

Manufacturer
Laboratoire Dr. Renaud
Effective date
2010-06-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:26:01

Label at a glance#

ProductSEBOBALANCE Purifying Sebo-absorbing Mask
Active ingredientSALICYLIC ACID
Label structure3 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 1% w/w.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

WATER/EAU • HECTORITE • BUTYLENE GLYCOL • SORBITOL • KAOLIN • MAGNESIUM ALUMINIUM SILICATE • ZINC OXIDE • PEG-40 HYDROGENATED CASTOR OIL • LACTIC ACID • XANTHAN GUM • ALMOND (PRUNUS AMYGDALUS DULCIS) OIL • ROSEMARY (ROSMARINUS OFFICINALIS) OIL • SAGE (SALVIA OFFICINALIS) OIL SPANISH • LAVANDIN (LAVANDULA LATIFOLIA) OIL • COLEUS FORSKOHLII OIL • GALANGAL (KAEMPFERIA GALANGA) EXTRACT • CHAMOMILE (ANTHEMIS NOBILIS) OIL • PEG-60 ALMOND GLYCERIDES • CAPRYLYL GLYCOL • CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL • NORDIHYDROGUAIARETIC ACID • OLEANOLIC ACID • ALLANTOIN • GLYCERIN • PHENOXYETHANOL • ETHYLHEXYLGLYCERIN • CARBOMER •

OTC - PURPOSE SECTION

For the treatment of acne and allows skin to heal.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Once or twice a week, after
a thorough cleansing of the skin, apply evenly
and sparingly to the face and the neck.
Pause for 20 minutes. Rinse liberally first with
lukewarm water, then with cold.

WARNINGS

WARNINGS SECTION

For external use only.
Using other topical acne medications at the same
time or immediately following use of this product
may increase dryness or irritation of the skin.
If this occurs, only one medication should be
used unless directed by a doctor. Avoid
direct contact with the eyes. If product gets
into the eyes, rinse liberally with water.
Discontinue use if skin irritation develops or
increases. If irritation persists, consult a doctor.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL




image of carton 60g label
image of carton 60g label
image of carton 60g label

image of tube 200g label
image of tube 200g label
image of tube 200g label

image of tube 60g label
image of tube 60g label
image of tube 60g label




INDICATIONS & USAGE SECTION

Enter section text here

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1014639salicylic acid 1 % PastePSN3
1014642Sebobalance 1 % Topical PastePSN3
1014642salicylic acid 0.01 MG/MG Paste [Sebobalance]SBD3
1014639salicylic acid 0.01 MG/MG PasteSCD3
1014639salicylic acid 1 % PasteSY3
1014642Sebobalance 0.01 MG/MG PasteSY3
1014642Sebobalance 1 % Topical PasteSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62499-535-092019-10-29C16284748780-1960f7f55-c4f7-8e05-e053-dbdaa90a074aDrug Facts
62499-535-112019-10-29C16284748780-1960f7f55-c4f7-8e05-e053-dbdaa90a074aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62499-535-08SEBOBALANCE Purifying Sebo-absorbing Mask60 g in 1 TUBEPASTE603
62499-535-09SEBOBALANCE Purifying Sebo-absorbing Mask200 g in 1 TUBEPASTE2003
62499-535-11SEBOBALANCE Purifying Sebo-absorbing Mask1 in 1 CARTONPASTE13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62499-535SEBOBALANCE PURIFYING SEBO-ABSORBING MASK (SALICYLIC ACID ) PASTE [LABORATOIRE DR. RENAUD]3Legacy NDC, 3 package rows20101007_21b4619d-324c-4ad5-b82b-40377e4a2f1d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZ3
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ3
ALLANTOININACTIVE INGREDIENT344S277G0Z3
ALMOND OILINACTIVE INGREDIENT66YXD4DKO93
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA3
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U3
CARBOMER 934INACTIVE INGREDIENTZ135WT92083
CHAMOMILE FLOWER OILINACTIVE INGREDIENT60F80Z61A93
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3P3
GALANGAL OILINACTIVE INGREDIENTK0951TAR6Z3
GLYCERININACTIVE INGREDIENTPDC6A3C0OX3
HECTORITEINACTIVE INGREDIENT08X4KI73EZ3
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEY3
KAOLININACTIVE INGREDIENT24H4NWX5CO3
LACTIC ACIDINACTIVE INGREDIENT33X04XA5AT3
LAVANDIN OILINACTIVE INGREDIENT9RES347CKG3
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NC3
MASOPROCOLINACTIVE INGREDIENT7BO8G1BYQU3
OLEANOLIC ACIDINACTIVE INGREDIENT6SMK8R7TGJ3
ORANGE OILINACTIVE INGREDIENTAKN3KSD11B3
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T3
ROSEMARY OILINACTIVE INGREDIENT8LGU7VM3933
SAGE OILINACTIVE INGREDIENTU27K0H1H2O3
SORBITOLINACTIVE INGREDIENT506T60A25R3
WATERINACTIVE INGREDIENT059QF0KO0R3
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE3
ZINC OXIDEINACTIVE INGREDIENTSOI2LOH54Z3

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62499-53562499-535-08, 62499-535-11, 62499-535-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 244 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SORBITOLSORBITOL506T60A25RTABLET, COATED / ORAL12.96 mgExact identifier — unii candidate
44 equally ranked IID candidates
LACTIC ACIDLACTIC ACID33X04XA5ATLOTION / TOPICAL5.7 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RGUM, CHEWING / ORAL6168 mgExact identifier — unii candidate
44 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCCAPSULE / ORAL60 mgExact identifier — unii candidate
17 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, DELAYED RELEASE / ORAL0.01 mgExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION, CONCENTRATE / ORAL300 mg/1mlExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYCAPSULE, EXTENDED RELEASE / ORAL410.82 mgExact identifier — unii candidate
12 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCONCENTRATE / ORAL600 mg/1mlExact identifier — unii candidate
44 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYTABLET, EXTENDED RELEASE / ORAL393 mgExact identifier — unii candidate
12 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / OPHTHALMIC0.88 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAMUSCULAR450 mgExact identifier — unii candidate
75 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL36 mgExact identifier — unii candidate
29 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYTABLET / SUBLINGUAL1.6 mgExact identifier — unii candidate
12 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SUSPENSION / SUBCUTANEOUS1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RINJECTION / SUBCUTANEOUS4.7 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii candidate
75 equally ranked IID candidates
LACTIC ACIDLACTIC ACID33X04XA5ATCONCENTRATE / ORAL50 mg/5mlExact identifier — unii candidate
18 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION/ DROPS / ORAL22 mgExact identifier — unii candidate
29 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL / TOPICAL1.05 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCONCENTRATE / ORAL1800 mgExact identifier — unii candidate
75 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RINJECTION / INTRALESIONAL45 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUPPOSITORY / VAGINAL227.9 mgExact identifier — unii candidate
75 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCSUSPENSION/ DROPS / ORAL4.15 mg/2.5mlExact identifier — unii candidate
17 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGUM, CHEWING / BUCCAL230 mgExact identifier — unii candidate
75 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYTABLET, FOR SUSPENSION / ORAL17 mgExact identifier — unii candidate
12 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEGEL / TOPICAL58 mgExact identifier — unii candidate
29 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPASTE / DENTAL14.6 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEAEROSOL, FOAM / TOPICAL0.27 %w/wExact identifier — unii candidate
29 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET / SUBLINGUAL50.5 mgExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCREAM, AUGMENTED / TOPICAL15 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / PERIODONTAL0.53 mgExact identifier — unii candidate
75 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYSUSPENSION / TOPICAL286 mgExact identifier — unii candidate
12 equally ranked IID candidates
LACTIC ACIDLACTIC ACID33X04XA5ATCAPSULE / ORAL132 mgExact identifier — unii candidate
18 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RLIQUID / ORAL53460 mgExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPOWDER, FOR SUSPENSION / ORAL12000 mgExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSYSTEM / TOPICAL6300 mgExact identifier — unii candidate
44 equally ranked IID candidates
ZINC OXIDEZINC OXIDESOI2LOH54ZSOLUTION / RESPIRATORY (INHALATION)3.11 %w/vExact identifier — unii candidate
6 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / AURICULAR (OTIC)63.64 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / VAGINALNAExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, COATED / ORAL14.21 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii candidate
75 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSPRAY / NASAL49 mgExact identifier — unii candidate
44 equally ranked IID candidates
CARBOMER 934CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)Z135WT9208GEL, METERED / TRANSDERMAL1 %w/wExact identifier — unii candidate
14 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TRANSDERMAL8.12 mgExact identifier — unii candidate
2 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCCREAM / TOPICAL3 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAVENOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TRANSDERMAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEELOZENGE / ORAL1264 mgExact identifier — unii candidate
29 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
LACTIC ACIDLACTIC ACID33X04XA5ATINJECTION / INTRACARDIAC0.01 %w/vExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii candidate
75 equally ranked IID candidates
ZINC OXIDEZINC OXIDESOI2LOH54ZINJECTION, SUSPENSION / SUBCUTANEOUSNAExact identifier — unii candidate
6 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RLIQUID / TOPICAL1 %w/wExact identifier — unii candidate
44 equally ranked IID candidates

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
6d00776f-043e-4e47-974d-a9f6fa63010821b4619d-324c-4ad5-b82b-40377e4a2f1d2010-06-29WarningsExact identifier
spl id: 6d00776f-043e-4e47-974d-a9f6fa630108
spl set id: 21b4619d-324c-4ad5-b82b-40377e4a2f1d

Reported adverse events (FAERS/openFDA)#

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