TULA Breakout Star Oil-free Acne Moisturizer: Package Insert and Label Information

TULA BREAKOUT STAR OIL-FREE ACNE MOISTURIZER- salicylic acid liquid
Tula Life LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active Ingredients

Salicylic Acid 2.0%

Purpose

Acne Treatment

Uses

• treats acne

• Helps prevent the development or new acne blemishes

Warnings

For external use only
Using other topical 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.

When using this product
• avoid contact with the eyes
• if contact occurs, rinse thoroughly with water

Keep out of reach of children

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

Directions

• 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
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

Aqua/Water/Eau, 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, Cirusllus 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, 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?

1-844-545-1236

Principal Display Panel

72296-020-50
(click image for full-size original)

TULA BREAKOUT STAR OIL-FREE ACNE MOISTURIZER
tula breakout star oil-free acne moisturizer liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:72296-020
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 2 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER
PROPANEDIOL
DIMETHICONE
GLYCERIN
DIMETHYL ISOSORBIDE
LACTOCOCCUS LACTIS
POLYSORBATE 20
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)
NIACINAMIDE
ALOE VERA LEAF
AZELAIC ACID
BISABOLOL OXIDE A
CETEARYL OLIVATE
CITRULLUS LANATUS WHOLE
CITRUS AURANTIUM FLOWER
EPILOBIUM ANGUSTIFOLIUM WHOLE
LACTIC ACID
ORYZA SATIVA WHOLE
PHENOXYETHANOL
SACCHARIDE ISOMERATE
SODIUM CHLORIDE
SODIUM LACTATE
SORBITAN ISOSTEARATE
SORBITAN OLIVATE
TRISODIUM ETHYLENEDIAMINE DISUCCINATE
ETHYLHEXYLGLYCERIN
XANTHAN GUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72296-020-50 1 TUBE in 1 CARTON contains a TUBE
1 50 g in 1 TUBE This package is contained within the CARTON (72296-020-50)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 11/25/2019
Labeler — Tula Life LLC (080051358)

Revised: 11/2019 Tula Life LLC

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