Label: TULA ULTIMATE SUN SERUM PENTAPEPTIDE SUNSCREEN BROAD SPECTRUM SPF 50- sunscreen serum liquid
- NDC Code(s): 72296-201-50
- 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 February 12, 2023
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
- Warnings
- Keep out of reach of children.
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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
- Questions or Comments?
- TULA Ultimate Sun Serum PentaPeptide Sunscreen Broad Spectrum SPF 50 Label
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INGREDIENTS AND APPEARANCE
TULA ULTIMATE SUN SERUM PENTAPEPTIDE SUNSCREEN BROAD SPECTRUM SPF 50
sunscreen serum liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72296-201 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 5.0076 g in 100 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 6 g in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:72296-201-50 1 in 1 CARTON 02/12/2023 1 50 mL 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 M020 02/12/2023 Labeler - Tula Life LLC (080051358) Registrant - Tula Life LLC (080051358)