FDA.reportPublic FDA data

Tula Skincare protect and go dewy glow sunscreen stick broad spectrum SPF 50

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2025-01-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:52:34

Label at a glance#

ProductTula Skincare protect and go dewy glow sunscreen stick broad spectrum SPF 50
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
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

Avobenzone 3.0%

Homosalate 10.0%

Octisalate 5.0%

Octocrylene 10.0%

OTC - PURPOSE SECTION

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

Polyamide-8, C12-15 alkyl benzoate, coco-caprylate/caprate, isopropyl isostearate, butyloctyl salicylate, polyamide-3, VP/eicosene copolymer, carica papaya (papaya) fruit extract, tetrahexyldecyl ascorbate, rubus chamaemorus seed oil, tocopherol, oryza sativa (rice) germ extract, oryza sativa (rice) extract, helianthus annuus (sunflower) seed oil, hylocereus undatus fruit extract, glycine soja (soybean) oil, tocopheryl acetate, caprylyl glycol, caprylic/capric triglyceride, diethylhexyl syringylidenemalonate, pentaerythrityl tetra =-di-t-butyl hydroxyhydrocinnamate, isostearic acid, polyglyceryl-3 diisostearate

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-844-545-1236

SPL UNCLASSIFIED SECTION

Dist. by TULA LIFE, INC.

NY, NY 10003

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TULA

protect + go

dewy glow

SUNSCREEN STICK

BROAD SPECTRUM SPF 50

0.5 OZ (14 g)

TULATULA

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84126-070-14Tula Skincare protect and go dewy glow sunscreen stick broad spectrum SPF 501 in 1 CARTONSTICK12
84126-070-14Tula Skincare protect and go dewy glow sunscreen stick broad spectrum SPF 5014 g in 1 CYLINDERSTICK142

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84126-070TULA SKINCARE PROTECT AND GO DEWY GLOW SUNSCREEN STICK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) STICK [THE PROCTER & GAMBLE MANUFACTURING COMPANY]2Current NDC, 2 package rows20250115_2b9acb63-b32c-336c-e063-6394a90a4a9c.zip

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84126-07084126-070-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYAMIDE-3 (12000 MW)L7P3YWF22XIACT
CAPRYLYL GLYCOL00YIU5438UIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
POLYAMIDE-8 (4500 MW)77723GV81AIACT
ISOPROPYL ISOSTEARATEC67IXB9Y7TIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
HYLOCEREUS UNDATUS FRUITWUG58TD53XIACT
VINYLPYRROLIDONE/EICOSENE COPOLYMER035MV9S1C3IACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
GLYCINE SOJA (SOYBEAN) OIL241ATL177AIACT
POLYGLYCERYL-3 DIISOSTEARATE46P231IQV8IACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
DIETHYLHEXYL SYRINGYLIDENEMALONATE3V5U97P248IACT
C12-15 ALKYL BENZOATEA9EJ3J61HQIACT
RUBUS CHAMAEMORUS SEED OILWH495F04LZIACT
TOCOPHEROLR0ZB2556P8IACT
RICE GERM7N2B70SFEZIACT
ISOSTEARIC ACIDX33R8U0062IACT
CARICA PAPAYA (PAPAYA) FRUITKU94FIY6JBIACT
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL3W1JG795YIIACT
PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE255PIF62MSIACT

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
Tula Skincare protect and go dewy glow sunscreen stick broad spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company2b9acb63-b32c-336c-e063-6394a90a4a9c2025-01-13WarningsExact identifier
ndc (package): 84126-070-14
ndc (product): 84126-070
ndc11 (package): 84126007014
spl id: 2b9dead9-3e98-cdc8-e063-6394a90ae096
spl set id: 2b9acb63-b32c-336c-e063-6394a90a4a9c

Reported adverse events (FAERS/openFDA)#

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