Label: TULA SKINCARE ACNE HEROES ACNE-CLEARING ROUTINE- acne-clearing routine kit kit
- NDC Code(s): 72296-902-01
- 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 February 11, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
-
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.
-
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
TULA Skincare Keep it Clear Acne Foam Cleanser:
Aqua/Water/Eau, Sodium Methyl 2-Sulfolaurate, Disodium 2-Sulfolaurate, Disodium Laureth Sulfosuccinate, Lactococcus Ferment Lysate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Azelaic Acid, Morinda Citrifolia Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Vaccinium Angustifolium (Blueberry) Fruit Extract, Zingiber Officinale (Ginger) Root Extract, Lactic Acid, Hydrolyzed Algin, Glycerin, Citric Acid, Phospholipids, Caprylyl Glycol, Sodium Chloride, Benzoic Acid, Sodium Hydroxide, Sodium Glycolate, Trisodium Dicarboxymethyl Alaninate, Butylene Glycol, Chlorphenesin, Sodium Benzoate, Ethylhexylglycerin, Phenoxyethanol
TULA breakout star oil-free acne moisturizer:
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
TULA acne clearing and tone correcting gel:
Water/Aqua/Eau, Sodium Polyacrylate, Sodium PCA, Glycerin, Polyacrylate Crosspolymer-6, Azelaic Acid, Lactococcus Ferment Lysate, Zinc PCA, Epilobium Angustifolium Flower/Leaf/Stem Extract, Niacinamide, Bisabolol, Allantoin, Sodium Hyaluronate, Lactic Acid, Sodium Benzoate, Sodium Chloride, Sodium Metabisulfite, Ehtylhexylglyceirn, Phenoxyethanol
- Questions or Comments?
- TULA Skincare Acne Heroes Acne-Clearing Routine Kit Artwork
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INGREDIENTS AND APPEARANCE
TULA SKINCARE ACNE HEROES ACNE-CLEARING ROUTINE
acne-clearing routine kit kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72296-902 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72296-902-01 1 in 1 CARTON 02/12/2023 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE 50 g in 100 Part 2 1 BOTTLE, PLASTIC 30 g in 100 Part 3 1 BOTTLE, PUMP 180 g in 100 Part 1 of 3 TULA BREAKOUT STAR OIL-FREE ACNE MOISTURIZER
acne moisturizer liquidProduct Information Item Code (Source) NDC:72296-904 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 PROPANEDIOL (UNII: 5965N8W85T) AZELAIC ACID (UNII: F2VW3D43YT) CITRULLUS LANATUS WHOLE (UNII: 3J5I6254YO) SACCHARIDE ISOMERATE (UNII: W8K377W98I) NIACINAMIDE (UNII: 25X51I8RD4) CITRUS AURANTIUM FLOWER (UNII: O730ZX2Z83) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM LACTATE (UNII: TU7HW0W0QT) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) LENTIL (UNII: 6O38V6B52O) EPILOBIUM ANGUSTIFOLIUM WHOLE (UNII: C278QS9YBT) XANTHAN GUM (UNII: TTV12P4NEE) ALOE VERA LEAF (UNII: ZY81Z83H0X) 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) .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z) CETEARYL OLIVATE (UNII: 58B69Q84JO) LACTIC ACID (UNII: 33X04XA5AT) ORYZA SATIVA WHOLE (UNII: 84IVV0906Z) PHENOXYETHANOL (UNII: HIE492ZZ3T) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) SORBITAN OLIVATE (UNII: MDL271E3GR) TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q) APPLE (UNII: B423VGH5S9) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 50 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 M006 Part 2 of 3 TULA ACNE CLEARING AND TONE CORRECTING GEL
tula acne clearing and tone correcting gel liquidProduct Information Item Code (Source) NDC:72296-903 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 SODIUM BENZOATE (UNII: OJ245FE5EU) WATER (UNII: 059QF0KO0R) ZINC (UNII: J41CSQ7QDS) .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z) EPILOBIUM ANGUSTIFOLIUM WHOLE (UNII: C278QS9YBT) PHENOXYETHANOL (UNII: HIE492ZZ3T) SACCHARIDE ISOMERATE (UNII: W8K377W98I) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM METABISULFITE (UNII: 4VON5FNS3C) HYALURONATE SODIUM (UNII: YSE9PPT4TH) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERIN (UNII: PDC6A3C0OX) LACTOCOCCUS LACTIS (UNII: F1A0PSN10V) NIACINAMIDE (UNII: 25X51I8RD4) AZELAIC ACID (UNII: F2VW3D43YT) LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) ALLANTOIN (UNII: 344S277G0Z) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 30 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M006 Part 3 of 3 TULA SKINCARE KEEP IT CLEAR ACNE FOAM CLEANSER
tula skincare keep it clear acne foam cleanser liquidProduct Information Item Code (Source) NDC:72296-905 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 PROPANEDIOL (UNII: 5965N8W85T) DIMETHYL ISOSORBIDE (UNII: SA6A6V432S) LACTOCOCCUS LACTIS (UNII: F1A0PSN10V) NIACINAMIDE (UNII: 25X51I8RD4) ALOE VERA LEAF (UNII: ZY81Z83H0X) AZELAIC ACID (UNII: F2VW3D43YT) SODIUM CHLORIDE (UNII: 451W47IQ8X) GLYCERIN (UNII: PDC6A3C0OX) EPILOBIUM ANGUSTIFOLIUM WHOLE (UNII: C278QS9YBT) SACCHARIDE ISOMERATE (UNII: W8K377W98I) XANTHAN GUM (UNII: TTV12P4NEE) BLUEBERRY (UNII: 253RUG1X1A) WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) POLYSORBATE 20 (UNII: 7T1F30V5YH) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4) .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z) CITRULLUS LANATUS WHOLE (UNII: 3J5I6254YO) CITRUS AURANTIUM FLOWER (UNII: O730ZX2Z83) ORYZA SATIVA WHOLE (UNII: 84IVV0906Z) PHENOXYETHANOL (UNII: HIE492ZZ3T) CETEARYL OLIVATE (UNII: 58B69Q84JO) LACTIC ACID (UNII: 33X04XA5AT) SODIUM LACTATE (UNII: TU7HW0W0QT) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) SORBITAN OLIVATE (UNII: MDL271E3GR) TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 180 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M006 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M006 02/12/2023 Labeler - TULA Life LLC (080051358) Registrant - TULA Life LLC (080051358)
