Label: TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30- brightening skin tint lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 3, 2024

If you are a consumer or patient please visit this version.

  • Active Ingredients

    Avobenzone 3%

    Octisalate 5%

  • Purpose

    Sunscreen

  • Uses

    Helps prevent sunburn • if used as directed with other
    sun protection measures (see Directions), decreases the
    risk of skin cancer and early skin aging caused by the sun

  • Warnings

    For external use only.

    Do not use on damaged or broken skin
    When using this product keep out of eyes. Rinse with water to remove.


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

  • 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

    Apply liberally 15 minutes before sun exposure.
    Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 am – 2 pm, wear long sleeved shirts, pants, hats and sunglasses.

    Children under 6 months: Ask a doctor

  • Inactive Ingredients

    Aqua/Water/Eau, C9-12 Alkane , Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Ethylhexyl Palmitate, Triethylhexanoin, Polyglyceryl-6 Polyhydroxystearate, Polyglyceryl-6 Polyricinoleate, Isododecane, Silica, Butylene Glycol, Disteardimonium Hectorite, Trimethylsiloxysilicate, VP/Eicosene Copolymer, Glycerin, Argania Spinosa Kernel Oil, Tocopheryl Acetate, VP/Hexadecene Copolymer, Octyldodecyl Neopentanoate, Sodium Chloride, Magnesium Sulfate, Boron Nitride, Sorbitan Oleate, Polyglycerin-6, Caesalpinia Spinosa Fruit Extract, Octyldodecanol, Safflower oil/ Palm oil aminopropanediol esters , Mica , Lactococcus Ferment Lysate, Alpha-Glucan Oligosaccharide, Hydrogenated Lecithin, Bisabolol, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Simethicone, Kappaphycus Alvarezii Extract, Pongamia Glabra Seed Oil , Beta Vulgaris (Beet) Root Extract, Cystoseira Tamariscifolia Extract, Inulin, Niacinamide, Tocopherol, Tetrahexyldecyl Ascorbate, Ascorbyl Palmitate, Lactic Acid, Polymnia Sonchifolia Root Juice, Lactobacillus Ferment, Curcuma Longa (Turmeric) Root Extract, Maltodextrin, Ceramide NP, Dunaliella Salina Extract , Haematococcus Pluvialis Extract , Acacia Seyal Gum Extract, Lactobacillus, Ethylhexylglycerin, Aluminum Hydroxide, Sodium Hyaluronate, Citric Acid, 1,2-Hexanediol, Caprylyl Glycol, Phenoxyethanol, Sodium Benzoate, Potassium Sorbate, Titanium Dioxide (CI 77891), Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499).

  • INDICATIONS & USAGE

    Stop use and ask a doctor if rash occurs.

  • Principal Display Panel

    PDPLabel-carton

  • INGREDIENTS AND APPEARANCE
    TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 
    brightening skin tint lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59735-202
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 30 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    KARUM SEED OIL (UNII: 62160PU6FJ)  
    SAFFLOWER (UNII: 4VBL71TY4Y)  
    SORBITAN (UNII: 6O92ICV9RU)  
    ISODODECANE (UNII: A8289P68Y2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
    POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
    KAPPAPHYCUS ALVAREZII (UNII: T479H08K2O)  
    CAESALPINIA SPINOSA FRUIT POD (UNII: EXY4496LWD)  
    LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
    VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
    SMALLANTHUS SONCHIFOLIUS ROOT JUICE (UNII: M9S7HX36CT)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    POLYGLYCERIN-6 (UNII: M51422LRAM)  
    MICA (UNII: V8A1AW0880)  
    INULIN (UNII: JOS53KRJ01)  
    LACTOCOCCUS LACTIS (UNII: F1A0PSN10V)  
    .ALPHA.-GLUCAN OLIGOSACCHARIDE (UNII: S95658MI3W)  
    TURMERIC (UNII: 856YO1Z64F)  
    BETA VULGARIS (UNII: 4G174V5051)  
    CYSTOSEIRA TAMARISCIFOLIA (UNII: HRU0KH4VFH)  
    VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
    PENTAERYTHRITOL 3,5-DI-TERT-BUTYL-4-HYDROXYHYDROCINNAMATE (UNII: A8VXR0397K)  
    LACTOBACILLUS ACIDOPHILUS (UNII: 1PRR1V42V5)  
    CERAMIDE NP (UNII: 4370DF050B)  
    HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472)  
    ACACIA SEYAL WHOLE (UNII: 0H7YR6DN6P)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CAPRYLIC/CAPRIC MONO/DI-GLYCERIDES (UNII: U72Q2I8C85)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DUNALIELLA SALINA (UNII: F4O1DKI9A6)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    Product Characteristics
    Colorbrown (shade 2 - very light cool) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59735-202-011 in 1 CARTON08/01/2022
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02008/01/2022
    Labeler - MANA Products, Inc (078870292)
    Establishment
    NameAddressID/FEIBusiness Operations
    MANA Products, Inc032870270manufacture(59735-202)
    Establishment
    NameAddressID/FEIBusiness Operations
    MANA Products,Inc078870292manufacture(59735-202)