FDA.reportPublic FDA data

Acne Fighting Foundation Caramel

Manufacturer
Zhejiang Ayan Biotech Co.,Ltd.
Effective date
2023-11-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:59:20

Label at a glance#

ProductAcne Fighting Foundation Caramel
Active ingredientSALICYLIC ACID
Label structure7 sections

Indications and uses

For the treatment of acne Helps prevent new acne blemishes

Dosage and administration

clear the skin thoroughly 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#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 0.5%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Uses

INDICATIONS & USAGE SECTION

  • For the treatment of acne
  • Helps prevent new acne blemishes

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

skin irritation and dryness is 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.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • clear the skin thoroughly 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

Water (Aqua), Cyclopentasiloxane, Dimethicone, Ethoxydiglycol, Propylene Glycol, PEG-10 Dimethicone, Hydrogenated Polyisobutene, Cyclohexasiloxane, Nylon-12, Dimethicone Crosspolymer, Dimethicone/PEG-10/15 Crosspolymer, Triethoxycaprylylsilane, Talc, Quaternium-18 Bentonite, Magnesium Sulfate, Butylene Glycol, Aloe Barbadensis Leaf Extract, Hamamelis Virginiana (Witch Hazel) Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Cinnamomum Camphora (Camphor) Bark Oil, Glycerin, Palmitoyl Hexapeptide-12, Caprylyl Glycol, Ethylhexylglycerin, Phenoxyethanol, MAY CONTAIN: Titanium Dioxide (CI 77891), Red Iron Oxide (CI 77491), Yellow Iron Oxide (CI 77492), Black Iron Oxide (CI 77499)

Questions or comments?

OTC - QUESTIONS SECTION

1-855-353-7320

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer PackageOuter PackageInner PackageInner Package

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
248684salicylic acid 0.5 % Topical CreamPSN2
248684salicylic acid 5 MG/ML Topical CreamSCD2
248684salicylic acid 0.5 % Topical CreamSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70412-435-01Acne Fighting Foundation Caramel1 in 1 BOXCREAM12
70412-435-01Acne Fighting Foundation Caramel36 mL in 1 BOTTLECREAM362

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70412-435ACNE FIGHTING FOUNDATION CARAMEL (SALICYLIC ACID) CREAM [ZHEJIANG AYAN BIOTECH CO.,LTD.]2Current NDC, Legacy NDC, 2 package rows20231108_92c4fe5f-fcc8-4dde-9f34-a55f53e009bb.zip

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70412-43570412-435-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CYCLOMETHICONE 50THT5PCI0RIACT
DIMETHICONE92RU3N3Y1OIACT
DIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
HYDROGENATED POLYBUTENE (1300 MW)7D1YQ9Y5EZIACT
CYCLOMETHICONE 6XHK3U310BAIACT
NYLON-12446U8J075BIACT
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)UF7620L1W6IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
TALC7SEV7J4R1UIACT
BENTOQUATAM7F465U79Q1IACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
ALOE VERA LEAFZY81Z83H0XIACT
WITCH HAZEL101I4J0U34IACT
TEA TREE OILVIF565UC2GIACT
CAMPHOR OIL75IZZ8Y727IACT
GLYCERINPDC6A3C0OXIACT
PALMITOYL HEXAPEPTIDE-12HO4ZT5S86CIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SALICYLIC ACIDO414PZ4LPZACTIB

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
Acne Fighting Foundation CaramelSALICYLIC ACIDZhejiang Ayan Biotech Co.,Ltd.92c4fe5f-fcc8-4dde-9f34-a55f53e009bb2023-11-06WarningsExact identifier
ndc (package): 70412-435-01
ndc (product): 70412-435
ndc11 (package): 70412043501
spl id: 098738da-207e-8b6a-e063-6294a90ae6e2
spl set id: 92c4fe5f-fcc8-4dde-9f34-a55f53e009bb

Reported adverse events (FAERS/openFDA)#

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