Label: TULA BREAKOUT STAR OIL-FREE ACNE MOISTURIZER liquid
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- NDC Code(s): 72296-020-15, 72296-020-50
- Packager: Tula Life LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated December 26, 2022
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- Active Ingredients
- Purpose
- Uses
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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
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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, 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?
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INGREDIENTS AND APPEARANCE
TULA BREAKOUT STAR OIL-FREE ACNE MOISTURIZER
tula breakout star oil-free acne moisturizer liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72296-020 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 2 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PROPANEDIOL (UNII: 5965N8W85T) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCERIN (UNII: PDC6A3C0OX) DIMETHYL ISOSORBIDE (UNII: SA6A6V432S) LACTOCOCCUS LACTIS (UNII: F1A0PSN10V) POLYSORBATE 20 (UNII: 7T1F30V5YH) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4) NIACINAMIDE (UNII: 25X51I8RD4) ALOE VERA LEAF (UNII: ZY81Z83H0X) AZELAIC ACID (UNII: F2VW3D43YT) .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z) CETEARYL OLIVATE (UNII: 58B69Q84JO) CITRULLUS LANATUS WHOLE (UNII: 3J5I6254YO) CITRUS AURANTIUM FLOWER (UNII: O730ZX2Z83) EPILOBIUM ANGUSTIFOLIUM WHOLE (UNII: C278QS9YBT) LACTIC ACID (UNII: 33X04XA5AT) ORYZA SATIVA WHOLE (UNII: 84IVV0906Z) PHENOXYETHANOL (UNII: HIE492ZZ3T) SACCHARIDE ISOMERATE (UNII: W8K377W98I) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM LACTATE (UNII: TU7HW0W0QT) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) SORBITAN OLIVATE (UNII: MDL271E3GR) TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) XANTHAN GUM (UNII: TTV12P4NEE) APPLE (UNII: B423VGH5S9) WATERMELON (UNII: 231473QB6R) LENTIL (UNII: 6O38V6B52O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72296-020-50 1 in 1 CARTON 12/26/2022 1 50 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:72296-020-15 1 in 1 CARTON 12/26/2022 2 15 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 12/26/2022 Labeler - Tula Life LLC (080051358)
