FDA.reportPublic FDA data

CAUDALIE Vinopure Acne Serum Salicylic Acid Acne Treatment Gel

Manufacturer
Caudalie USA Inc.
Effective date
2025-12-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:28:06

Label at a glance#

ProductCAUDALIE Vinopure Acne Serum
Active ingredientSALICYLIC ACID
Label structure14 sections

Indications and uses

• For the treatment/management of acne • Clears acne pimples and allows skin to heal • Helps prevent new acne pimples and blackheads from forming

Dosage and administration

• Clean the skin throughly before applying this product. • Cover the entire affected area with a thin layer one to three times daily. • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor. • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient Purpose

Salicylic Acid 0.5% ....................... Acne Medication

OTC - PURPOSE SECTION

Active ingredient Purpose

Salicylic Acid 0.5%................Acne Medication

Uses

INDICATIONS & USAGE SECTION

• For the treatment/management of acne
• Clears acne pimples and allows skin to heal
• Helps prevent new acne pimples and blackheads from forming

Warnings

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

When using this product • skin irritation and dryness are 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

WARNINGS SECTION

Sunburn Alert: This product contains alpha hydroxy acids (AHAs) that may increase your skin’s sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards.

Directions

DOSAGE & ADMINISTRATION SECTION

• Clean the skin throughly before applying this product.

• Cover the entire affected area with a thin layer one to three times daily.

• Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.

• If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Alcohol, Aqua/Water/Eau, Butylene Glycol, Citral, Citric Acid, Citronellol, Cymbopogon Citratus Leaf Oil, Geraniol, Gluconolactone, Helianthus Annuus (Sunflower) Seed Oil, Lavandula Hybrida Oil, Limonene, Linalool, Melissa Officinalis Leaf Oil, Mentha Piperita (Peppermint) Oil, Niacinamide, Palmitoyl Grape Seed Extract, Pelargonium Graveolens Flower Oil, Rosa Damascena Flower Water,
Rosmarinus Officinalis (Rosemary) Leaf Oil, Sodium Citrate, Sodium Hyaluronate, Sodium Hydroxide, Sodium Phytate, Triethyl Citrate, Tocopherol, Xanthan Gum.

Questions?

OTC - QUESTIONS SECTION

+1-866-826-1615

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CAUDALIE

Vinopure Acne Serum 30 mL - 1 Fl. Oz. 30 mL Primary Label30 mL Primary Label

30 mL Secondary Label30 mL Secondary Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CAUDALIE

Vinopure Acne Serum

10 mL - 0.3 Fl. Oz.

10 mL Primary Label10 mL Primary Label

10 mL Secondary Label10 mL Secondary Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CAUDALIE

Vinopure Acne Serum

Acne Set containing 10 mL - 0.3 Fl. Oz.

Acne Set LabelAcne Set Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CAUDALIE

Vinopure Acne Serum

Acne Set containing 30 mL - 1 Fl. Oz.

Acne Set Label 2025Acne Set Label 2025

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
252296salicylic acid 0.5 % Topical GelPSN3
252296salicylic acid 0.005 MG/MG Topical GelSCD3
252296salicylic acid 0.5 % Topical GelSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76296-070-10CAUDALIE Vinopure Acne Serum10 mL in 1 BOTTLEGEL103
76296-070-10CAUDALIE Vinopure Acne Serum1 in 1 CARTONGEL13
76296-070-19CAUDALIE Vinopure Acne Serum10 mL in 1 BOTTLEGEL103
76296-070-19CAUDALIE Vinopure Acne Serum1 in 1 CARTONGEL13
76296-070-30CAUDALIE Vinopure Acne Serum30 mL in 1 BOTTLEGEL303
76296-070-30CAUDALIE Vinopure Acne Serum1 in 1 CARTONGEL13
76296-070-39CAUDALIE Vinopure Acne Serum1 in 1 CARTONGEL13
76296-070-39CAUDALIE Vinopure Acne Serum30 mL in 1 BOTTLEGEL303

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76296-07076296-070-30, 76296-070-10, 76296-070-19, 76296-070-39

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CITRALT7EU0O9VPPIACT
CITRONELLOLP01OUT964KIACT
SODIUM PHYTATE88496G1ERLIACT
XANTHAN GUMTTV12P4NEEIACT
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL3W1JG795YIIACT
LIMONENE, (+/-)-9MC3I34447IACT
PALMITOYL GRAPE SEED EXTRACTZZE3L9H7KHIACT
GERANIOLL837108USYIACT
LINALOOL, (+/-)-D81QY6I88EIACT
ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL8LGU7VM393IACT
MENTHA PIPERITA (PEPPERMINT) OILAV092KU4JHIACT
PELARGONIUM GRAVEOLENS FLOWER OIL3K0J1S7QGCIACT
SODIUM HYALURONATEYSE9PPT4THIACT
SODIUM HYDROXIDE55X04QC32IIACT
LAVANDULA HYBRIDA OIL9RES347CKGIACT
MELISSA OFFICINALIS LEAF OILPTP6R7263MIACT
CITRIC ACID2968PHW8QPIACT
CYMBOPOGON CITRATUS LEAF OIL5BIA40E9EDIACT
NIACINAMIDE25X51I8RD4IACT
TRIETHYL CITRATE8Z96QXD6UMIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
SALICYLIC ACIDO414PZ4LPZACTIB
WATER059QF0KO0RIACT
GLUCONOLACTONEWQ29KQ9POTIACT
SODIUM CITRATE1Q73Q2JULRIACT
ROSA DAMASCENA FLOWERJWB78P295AIACT

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
CAUDALIE Vinopure Acne SerumSALICYLIC ACIDCaudalie USA Inc.266ba6e3-5450-e9a9-e063-6394a90ab8f42025-12-22WarningsExact identifier
ndc (package): 76296-070-30
ndc (package): 76296-070-19
ndc (package): 76296-070-39
ndc (package): 76296-070-10
ndc (product): 76296-070
ndc11 (package): 76296007010
ndc11 (package): 76296007019
ndc11 (package): 76296007039
ndc11 (package): 76296007030
spl id: 468e0076-5ea4-e4ed-e063-6294a90a5c19
spl set id: 266ba6e3-5450-e9a9-e063-6394a90ab8f4

Reported adverse events (FAERS/openFDA)#

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