FDA.reportPublic FDA data

Tula Skincare Breakout Star Lightweight Acne Moisturizer

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2026-03-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:49:22

Label at a glance#

ProductTula Skincare Breakout Star Lightweight Acne Moisturizer
Active ingredientSALICYLIC ACID
Label structure10 sections

Indications and uses

For treatment of acne

Dosage and administration

Clean 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 uses 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#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 2%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Uses

INDICATIONS & USAGE SECTION

  • For treatment of acne

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

Apply only to areas with acne

Avoid contact with the eyes

If contact occurs, rinse thoroughly with water

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.

OTC - STOP USE SECTION

Stop use and ask a doctor if skin irritation occurs/gets worse.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Clean 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 uses 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 INGREDIENT SECTION

WATER, PROPANEDIOL, DIMETHICONE, GLYCERIN, DIMETHYL ISOSORBIDE, LACTOCOCCUS FERMENT LYSATE, POLYSORBATE 20, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, NIACINAMIDE, ALOE BARBADENSIS LEAF JUICE, AZELAIC ACID, BISABOLOL, CETEARYL OLIVATE, CITRULLUS LANATUS (WATERMELON) FRUIT EXTRACT, PYRUS MALUS (APPLE) FRUIT EXTRACT, CITRUS AURANTIUM DULCIS (ORANGE) PEEL EXTRACT, EPILOBIUM ANGUSTIFOLIUM FLOWER/LEAF/STEM EXTRACT, LACTIC ACID, LENS ESCULENTA (LENTIL) FRUIT EXTRACT, OCIMUM SANCTUM LEAF EXTRACT, OZONIZED ORYZA SATIVA (RICE) CALLUS CULTURE EXTRACT, PHENOXYETHANOL, POLYACRYLATE CROSSPOLYMER-6, SACCHARIDE ISOMERATE, SODIUM CHLORIDE, SODIUM LACTATE, SODIUM PCA, SORBITAN ISOSTEARATE, SORBITAN OLIVATE, TRISODIUM ETHYLENEDIAMINE DISUCCINATE, ETHYLHEXYLGLYCERIN, XANTHAN GUM

Questions or Comments?:

OTC - QUESTIONS SECTION

1-844-545-1236

SPL UNCLASSIFIED SECTION

Made in the USA from local & globally sourced materials

DIST. BY: TULA LIFE, INC. NY, NY 10003

#1035D TULA.COM

PRINCIPAL DISPLAY PANEL - 50 mL carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tula Skincare

breakout star

lightweight acne

moisturizer

salicylic acid

acne treatment

50 mL (1.7 FL OZ)

TULATULA

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
317152salicylic acid 2 % Topical CreamPSN2
317152salicylic acid 20 MG/ML Topical CreamSCD2
317152salicylic acid 2 % Topical CreamSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
6c6fc281-9445-2e9e-1c29-a09ddbc4299cProduct name220200213
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
2a856070-cbe7-4f85-be0f-09885ff91196Product name120150806
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84126-229-15Tula Skincare Breakout Star Lightweight Acne Moisturizer15 mL in 1 TUBECREAM152
84126-229-50Tula Skincare Breakout Star Lightweight Acne Moisturizer50 mL in 1 BOTTLE, PUMPCREAM502
84126-229-50Tula Skincare Breakout Star Lightweight Acne Moisturizer1 in 1 CARTONCREAM12
84126-229-51Tula Skincare Breakout Star Lightweight Acne Moisturizer50 mL in 1 BOTTLE, PUMPCREAM502

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84126-22984126-229-50, 84126-229-15, 84126-229-51

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Name, UNII, Kind table
NameUNIIKind
SACCHARIDE ISOMERATEW8K377W98IIACT
PROPANEDIOL5965N8W85TIACT
PYRUS MALUS (APPLE) FRUITB423VGH5S9IACT
SODIUM LACTATETU7HW0W0QTIACT
HOLY BASIL LEAFSCJ765569PIACT
POLYACRYLATE CROSSPOLYMER-6Q7UI015FF9IACT
VICIA LENS FRUITZYZ076G9JHIACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT
SORBITAN OLIVATEMDL271E3GRIACT
LACTIC ACID33X04XA5ATIACT
TRISODIUM ETHYLENEDIAMINE DISUCCINATEYA22H34H9QIACT
XANTHAN GUMTTV12P4NEEIACT
AZELAIC ACIDF2VW3D43YTIACT
BISABOLOL24WE03BX2TIACT
PHENOXYETHANOLHIE492ZZ3TIACT
GLYCERINPDC6A3C0OXIACT
SALICYLIC ACIDO414PZ4LPZACTIB
NIACINAMIDE25X51I8RD4IACT
EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP08H094218DIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
SODIUM PCA469OTG57A2IACT
LACTOCOCCUS LACTISF1A0PSN10VIACT
SODIUM CHLORIDE451W47IQ8XIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)86FQE96TZ4IACT
CITRUS AURANTIUM DULCIS (ORANGE) PEEL POWDERTI9T76XD44IACT
DIMETHYL ISOSORBIDESA6A6V432SIACT
RICE GERM7N2B70SFEZIACT
WATER059QF0KO0RIACT
ALOE BARBADENSIS LEAF JUICERUE8E6T4NBIACT
DIMETHICONE92RU3N3Y1OIACT
WATERMELON231473QB6RIACT
POLYSORBATE 207T1F30V5YHIACT

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tula Skincare Acne Heroes Acne Clearing KitSALICYLIC ACIDThe Procter & Gamble Manufacturing Company5967255f-b511-9c7f-e063-6294a90a3e632026-08-19WarningsExact identifier
ndc (package): 84126-229-15
ndc11 (package): 84126022915
Tula Skincare Clear Skin Starters Travel Size Acne and Blemish Fighting KitSALICYLIC ACIDThe Procter & Gamble Manufacturing Company4dc9e3eb-c4d0-b5e1-e063-6394a90a9b7e2026-03-24WarningsExact identifier
ndc (package): 84126-229-15
ndc11 (package): 84126022915
Tula Skincare Breakout Star Lightweight Acne MoisturizerSALICYLIC ACIDThe Procter & Gamble Manufacturing Company4bd1d5f5-1b3c-5e82-e063-6394a90a64542026-03-09WarningsExact identifier
ndc (package): 84126-229-51
ndc (package): 84126-229-50
ndc (package): 84126-229-15
ndc (product): 84126-229
ndc11 (package): 84126022950
ndc11 (package): 84126022951
ndc11 (package): 84126022915
spl id: 4c9c41c7-6fcd-61fa-e063-6294a90a4168
spl set id: 4bd1d5f5-1b3c-5e82-e063-6394a90a6454

Reported adverse events (FAERS/openFDA)#

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