FDA.reportPublic FDA data

Tula Skincare Protect and Deflect Mineral Sunscreen Broad Spectrum SPF 30

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2025-01-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:41:28

Label at a glance#

ProductTula Skincare Protect and Deflect Mineral Sunscreen Broad Spectrum SPF 30
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure10 sections

Indications and 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

Dosage and administration

apply liberally 15 minutes before sun exposure reapply at least every 2 hours use 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 sun, especially from 1...

Storage and handling

protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

TITANIUM DIOXIDE 3.6%

ZINC OXIDE 2.34%

OTC - PURPOSE SECTION

Sunscreen

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use

  • on damaged or broken skin

OTC - WHEN USING SECTION

When using this product

  • keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use 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 sun, especially from 10 a.m. - 2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses
  • children under 6 months: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • protect this product from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

WATER, ISODODECANE, C12-15 ALKYL BENZOATE, DIMETHICONE, TRIETHYLHEXANOIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, BUTYLOCTYL SALICYLATE, CAPRYLYL METHICONE, SILICA, STYRENE/ACRYLATES COPOLYMER, PENTYLENE GLYCOL, MAGNESIUM SULFATE, TRIOLEIN, LACTOBACILLUS, LACTOBACILLUS FERMENT, LACTOCOCCUS FERMENT LYSATE, BETA VULGARIS (BEET) ROOT EXTRACT, CURCUMA LONGA (TURMERIC) ROOT EXTRACT, PRUNUS PERSICA (PEACH) LEAF EXTRACT, EPILOBIUM ANGUSTIFOLIUM FLOWER/LEAF/STEM EXTRACT, HEDYCHIUM CORONARIUM ROOT EXTRACT, INULIN, LACTIC ACID, POLYMNIA SONCHIFOLIA (YACON) ROOT JUICE, ALPHA-GLUCAN OLIGOSACCHARIDE, LITHOTHAMNION CALCAREUM POWDER, ZINC SULFATE, AMINOPROPYL TRIETHOXYSILANE, BUTYLENE GLYCOL, TOCOPHEROL, DIATOMACEOUS EARTH, POLYGLYCERYL-3 POLYRICINOLEATE, DIMETHICONE/PEG-10/15 CROSSPOLYMER, DIPROPYLENE GLYCOL, GLYCERIN, DISTEARDIMONIUM HECTORITE, ISOPROPYL TITANIUM TRIISOSTEARATE, ISOSTEARIC ACID, MALTODEXTRIN, MANNITOL, MICA, NYLON-12, PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, PHENYL TRIMETHICONE, POLYHYDROXYSTEARIC ACID, PROPANEDIOL, PROPYLENE CARBONATE, RUBUS IDAEUS (RASPBERRY) FRUIT EXTRACT, PYRUS MALUS (APPLE) FRUIT EXTRACT, SODIUM BENZOATE, SODIUM CITRATE, SODIUM METABISULFITE, STEARIC ACID, ETHYLHEXYLGLYCERIN, PHENOXYETHANOL, SODIUM CHLORIDE, AMMONIUM HYDROXIDE, TRISODIUM ETHYLENEDIAMINE DISUCCINATE, 1,2-HEXANEDIOL, CAPRYLYL GLYCOL, CI 77891/TITANIUM DIOXIDE, CI 77491/CI77492/IRON OXIDES

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-844-545-1236

SPL UNCLASSIFIED SECTION

Distr. by : TULA LIFE, INC. NY, NY 10003

PRINCIPAL DISPLAY PANEL - 45 mL CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TULA

SKINCARE

protect + deflect

mineral sunsceren fluid

BROAD SPECTRUM SPF 30


45 mL (1.52 FL OZ)

TULATULA

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84126-072TULA SKINCARE PROTECT AND DEFLECT MINERAL SUNSCREEN BROAD SPECTRUM SPF 30 (TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1Unmatched20250210_2bafca5a-9a6e-16b8-e063-6294a90ab919.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 62 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84126-07284126-072-45

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 60 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISOPROPYL TITANIUM TRIISOSTEARATE949E3KBJ1IIACT
MICAV8A1AW0880IACT
POLYGLYCERYL-3 PENTARICINOLEATE7Q0OK5DOT4IACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
MAGNESIUM SULFATEDE08037SABIACT
NYLON-12446U8J075BIACT
EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP08H094218DIACT
PHYMATOLITHON CALCAREUM6J1M3WA0ZKIACT
CAPRYLYL GLYCOL00YIU5438UIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
PHENOXYETHANOLHIE492ZZ3TIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIB
PYRUS MALUS (APPLE) FRUITB423VGH5S9IACT
SODIUM CHLORIDE451W47IQ8XIACT
DIATOMACEOUS EARTH2RF6EJ0M85IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
C12-15 ALKYL BENZOATEA9EJ3J61HQIACT
INULINJOS53KRJ01IACT
DIPROPYLENE GLYCOLE107L85C40IACT
MANNITOL3OWL53L36AIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
HEDYCHIUM CORONARIUM ROOT92A6N0IQN9IACT
BEETN487KM8COKIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
LACTOBACILLUS5307V7XW8IIACT
PENTYLENE GLYCOL50C1307PZGIACT
POLYMNIA SONCHIFOLIA ROOT JUICEM9S7HX36CTIACT
PROPANEDIOL5965N8W85TIACT
SODIUM BENZOATEOJ245FE5EUIACT
TRISODIUM ETHYLENEDIAMINE DISUCCINATEYA22H34H9QIACT
CURCUMA LONGA (TURMERIC) ROOT856YO1Z64FIACT
PROPYLENE CARBONATE8D08K3S51EIACT
RUBUS IDAEUS (RASPBERRY) FRUIT4N14V5R27WIACT
SODIUM METABISULFITE4VON5FNS3CIACT
TRIETHYLHEXANOIN7K3W1BIU6KIACT
AMMONIA5138Q19F1XIACT
CAPRYLYL METHICONEQ95M2P1KJLIACT
SODIUM CITRATE1Q73Q2JULRIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
3d365f23-6037-95f1-e063-6294a90a707b2bafca5a-9a6e-16b8-e063-6294a90ab9192025-08-25WarningsExact identifier
spl set id: 2bafca5a-9a6e-16b8-e063-6294a90ab919

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.