Label: TULA ULTIMATE SUN SERUM PENTAPEPTIDE SUNSCREEN BROAD SPECTRUM SPF 50- sunscreen serum liquid

  • 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 12, 2023

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  • Active ingredient

    Titanium dioxide 6%
    Zinc oxide 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.
    Stop use and ask a doctor if rash occurs.

  • Keep out of reach of children.

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

  • Directions

    • Shake well before use

    • Apply liberally 15 minutes before sun exposure.
    • Reapply at least every 2 hour.
    • 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

    WATER/EAU/AQUA, C12-15 ALKYL BENZOATE, DIMETHICONE, ISODODECANE, TRIETHYLHEXANOIN, BUTYLOCTYL SALICYLATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, SILICA, CAPRYLYL METHICONE, POLYGLYCERYL-3 POLYRICINOLEATE, STYRENE/ACRYLATES COPOLYMER, PENTYLENE GLYCOL, MAGNSESIUM SULFATE, TRIOLEIN, 1,2-HEXANEDIOL, ALPHA-GLUCAN OLIGOSACCHARIDE, AMINOPROPYL TRIETHOXYSILANE, AMMONIUM HYDROXIDE, BETA VULGARIS (BEET) ROOT EXTRACT, BUTYLENE GLYCOL, CAPRYLYL GLYCOL, CITRIC ACID, COCOS NUCIFERA (COCONUT) FRUIT EXTRACT, CURCUMA LONGA (TURMERIC) ROOT EXTRACT, DIATOMACEOUS EARTH, DIMETHICONE/PEG-10/15 CROSSPOLYMER, DIPROPYLENE GLYCOL, DISTEARDIMONIUM HECTORITE, EPILOBIUM ANGUSTIFOLIUM FLOWER/LEAF/STEM EXTRACT, ETHYLHEXYLGLYCERIN, GLYCERIN, HEDYCHIUM CORONARIUM ROOT EXTRACT, HEXYLENE GLYCOL, HYDRANGEA ARBORESCENS ROOT EXTRACT, INULIN, ISOSTEARIC ACID, JASMINUM OFFICINALE (JASMINE) FLOWER EXTRACT, JASMINUM OFFICINALE (JASMINE) FLOWER/LEAF EXTRACT, LACTIC ACID, LACTOBACILLUS, LACTOBACILLUS FERMENT, LACTOCOCCUS FERMENT LYSATE, LITHOTHAMNION CALCAREUM POWDER, MALTODEXTRIN, MANNITOL, MICA, MORUS ALBA ROOT EXTRACT, NYLON-12, PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, PENTAPEPTIDE-21, PENTAPEPTIDE-34 TRIFLUOROACETATE, PHENOXYETHANOL, POLYHYDROXYSTEARIC ACID, POLYMNIA SONCHIFOLIA ROOT JUICE, POLYSORBATE 20, POTASSIUM SORBATE, PROPANEDIOL, PROPYLENE CARBONATE, PRUNUS ARMENIACA (APRICOT) FRUIT EXTRACT, PRUNUS PERSICA (PEACH) FRUIT EXTRACT, PRUNUS PERSICA (PEACH) LEAF EXTRACT, PYRUS MALUS (APPLE) FRUIT EXTRACT, RESVERATROL, RUBUS IDAEUS (RASPBERRY) FRUIT EXTRACT, SCUTELLARIA LATERIFLORA EXTRACT, SODIUM BENZOATE, SODIUM CHLORIDE, SODIUM CITRATE, SODIUM METABISULFITE, STEARIC ACID, TOCOPHEROL, TRISODIUM ETHYLENEDIAMINE DISUCCINATE, ZINC SULFATE, TITANIUM DIOXIDE (CI 77891).

  • Other Information

    Protect this product from direct heat and excessive sun.

  • Questions or Comments?

    1-844-545-1236

  • TULA Ultimate Sun Serum PentaPeptide Sunscreen Broad Spectrum SPF 50 Label

    TULA SKINCARE

    Ultimate Sun Serum PentaPeptide Sunscreen

    Broad Spectrum SPF 50

    UVA + UVB Protection

    1.69 FL. OZ / 50 mL

    Ultimate Sun Serum Artwork

  • INGREDIENTS AND APPEARANCE
    TULA ULTIMATE SUN SERUM PENTAPEPTIDE SUNSCREEN  BROAD SPECTRUM SPF 50
    sunscreen serum liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72296-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE5.0076 g  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE6 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIATOMACEOUS EARTH (UNII: 2RF6EJ0M85)  
    DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    BETA VULGARIS (UNII: 4G174V5051)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    MICA (UNII: V8A1AW0880)  
    MORUS ALBA ROOT (UNII: CST1G9BZGD)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    HEDYCHIUM CORONARIUM ROOT (UNII: 92A6N0IQN9)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    APRICOT FRUIT VOLATILE OIL (UNII: 8T51U45R12)  
    SCUTELLARIA LATERIFLORA WHOLE (UNII: 7BP4DH5PDC)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    APPLE JUICE (UNII: 9871T0PD5P)  
    PRUNUS PERSICA LEAF (UNII: VN3501T41P)  
    RESVERATROL (UNII: Q369O8926L)  
    WATER (UNII: 059QF0KO0R)  
    ISODODECANE (UNII: A8289P68Y2)  
    TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCONUT JUICE (UNII: AMN6S4M09G)  
    LACTOBACILLUS ACIDOPHILUS (UNII: 1PRR1V42V5)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MANNITOL (UNII: 3OWL53L36A)  
    NYLON-12 (UNII: 446U8J075B)  
    PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    PENTAPEPTIDE-34 TRIFLUOROACETATE (UNII: SQS1FA1FGW)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    INULIN (UNII: JOS53KRJ01)  
    TRIOLEIN, 1-C-14 (UNII: 2ZML2Z5Q7B)  
    JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)  
    JASMINUM OFFICINALE LEAF (UNII: 6OG06384ID)  
    RASPBERRY JUICE (UNII: 427AYI9PDE)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ZINC SULFATE (UNII: 89DS0H96TB)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    EPILOBIUM ANGUSTIFOLIUM WHOLE (UNII: C278QS9YBT)  
    HYDRANGEA ARBORESCENS ROOT (UNII: SFK828Q2DE)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PEACH (UNII: 3OKE88I3QG)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72296-201-501 in 1 CARTON02/12/2023
    150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02002/12/2023
    Labeler - Tula Life LLC (080051358)
    Registrant - Tula Life LLC (080051358)