Label: TULA SKINCARE PROTECT GLOW DAILY SUNSCREEN GEL BROAD SPECTRUM SPF 30 lotion

  • 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 24, 2021

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

  • Active Ingredients

    Avobenzone 3%

    Homosalate 10%

    Octisalate 5%

  • 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.
    Stop use and ask a docor if rash occurs
    Keep out of reach of children. If swalled, get medical help or contact a Poison Control Center right away.

  • Directions

    • apply generously 15 minutes before sun exposure
    • reapply at least every 2 hours
    • use a water-resistant sunscreen if swimming or sweating
    • 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
    value of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m. - 2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses
    • children under 6 months of age: Ask a doctor

  • Inactive ingredients

    Aqua/Water/Eau, Butyloctyl Salicylate, Pentylene Glycol,
    Lactococcus Ferment Lysate, 1,2-Hexanediol, Silica, Ectoin,
    Glycerin, Arginine, Hydroxyectoin, Ananas Sativus
    (Pineapple) Fruit Extract, Carica Papaya (Papaya) Fruit
    Extract, Lactic Acid, Camellia Sinensis Leaf Extract, Hedychium
    Coronarium Root Extract, Triethyl Citrate, Citrus Aurantium
    Dulcis (Orange) Peel Extract, Citrus Limon (Lemon) Peel
    Extract, Pyrus Communis (Pear) Fruit Extract, Pyrus Malus
    (Apple) Fruit Extract, Rubus Idaeus (Raspberry) Fruit Extract,
    Vanilla Planifolia Fruit Extract, Pimpinella Anisum Fruit
    Extract, Mica, Tocopherol, Ammonium Acryloyldimethyltaurate/
    VP Copolymer, Synthetic Fluorphlogopite, Hydrolyzed
    Wheat Protein/PVP Crosspolymer, Carbomer, Dibutyl Lauroyl
    Glutamide, Dibutyl Ethylhexanoyl Glutamide, Propanediol,
    Trisodium Ethylenediamine Disuccinate, Sodium Chloride,
    Sodium Benzoate, Ehtylhexylglycerin, Tin Oxide,
    Phenoxyethanol

  • Other Information

    • protect the product in this container from excessive heat and direct sun

  • Questions or Comments?

    1-844-545-1236

  • Principal Dispplay Panel

    72296-050-5072296-050-50

  • INGREDIENTS AND APPEARANCE
    TULA SKINCARE PROTECT GLOW DAILY SUNSCREEN GEL BROAD SPECTRUM SPF 30 
    tula skincare protect glow daily sunscreen gel broad spectrum spf 30 lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72296-050
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    LACTOCOCCUS LACTIS (UNII: F1A0PSN10V)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    ECTOINE (UNII: 7GXZ3858RY)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SILICON (UNII: Z4152N8IUI)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)  
    ARGININE (UNII: 94ZLA3W45F)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    DIBUTYL LAUROYL GLUTAMIDE (UNII: 3V7K3IA58X)  
    DIBUTYL ETHYLHEXANOYL GLUTAMIDE (UNII: 0IAF2L30VS)  
    HYDROXYECTOIN (UNII: CIJ7YN252E)  
    PINEAPPLE (UNII: 2A88ZO081O)  
    CARICA PAPAYA LEAF (UNII: 66J7636Z2I)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)  
    HEDYCHIUM CORONARIUM ROOT (UNII: 92A6N0IQN9)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CITRUS AURANTIUM FRUIT (UNII: DQD16J2B5O)  
    PEAR (UNII: 2ZN8DWC0YF)  
    RUBUS IDAEUS LEAF (UNII: 8O2V33JG64)  
    VANILLA PLANIFOLIA LEAF (UNII: WER36ZQQ2R)  
    PIMPINELLA ANISUM WHOLE (UNII: HO63CL229O)  
    APPLE (UNII: B423VGH5S9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72296-050-501 in 1 CARTON12/24/2021
    150 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/24/2021
    Labeler - Tula Life LLC (080051358)