FDA.reportPublic FDA data

Triple Protection Sunscreen Broad Spectrum SPF 30

Manufacturer
Vivier Pharma Inc
Effective date
2023-10-19
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
legacy-cache
Hydrated at
2026-08-01 21:23:49

Label at a glance#

ProductTriple Protection Sunscreen Broad Spectrum SPF 30
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure7 sections

Indications and uses

Helps prevent sunburn and provides a sun protection factor of 30. Ideal for daily use; can be applied under makeup.

Dosage and administration

Apply daily to face, neck and chest. Apply liberally and evenly 15 minutes before sun exposure. Reapply at least every 2 hours or as needed after towel drying, perspiring heavily or washing. For use on children less than 6 months of age, consult a healthcare practitioner. Use a water resistant sunscreen if swimming or sweating.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 10.0%
Zinc Oxide 8.0%

PURPOSE

OTC - PURPOSE SECTION

Sunscreen

USES

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn and provides a sun protection factor of 30.
  • Ideal for daily use; can be applied under makeup.

WARNINGS

WARNINGS SECTION

For external use only

  • The sun may cause sunburn, premature aging of the skin and skin cancer. Avoiding the sun, wearing protective clothing and
    regular use of sunscreens over the years may reduce the chance of these harmful effects.​

When using this product

OTC - WHEN USING SECTION

  • Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
  • Do not use on damaged or broken skin.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Rash or irritation develops and lasts.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • Apply daily to face, neck and chest.
  • Apply liberally and evenly 15 minutes before sun exposure.
  • Reapply at least every 2 hours or as needed after towel drying, perspiring heavily or washing.
  • For use on children less than 6 months of age, consult a healthcare practitioner.
  • Use a water resistant sunscreen if swimming or sweating.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

ALUMINA, AMMONIUM ACRYLOYLDIMETHYLTAURATE, BIS PEG/PPG-16-16 PEG/PPG16/16 DIMETHICONE, BUTYLPARABEN, C12-15 ALKYL
BENZOATE, CAMELIA SINENSIS (GREEN TEA) EXTRACT, CAPRYLIC/- CAPRIC TRIGLYCERIDE, CETEARETH 20, CETEARYL ALCOHOL, CETYL
DIMETHICONE, CITRUS MEDICA LIMONUM (LEMON BIOFLAVANOIDS) PEEL EXTRACT, CYCLOMETHICONE, DIMETHICONE, DIPROPYLENE GLYCOL DIBENZOATE, EICOSENE COPOLYMER, ETHYLPARABEN, GLYCERIN, GLYCERYL STEARATE, ISOPROPYL TITANIUM TRIISOSTEARATE, METHYLPARABEN, PHENOXYETHANOL, POLYHYDROXYSTEARIC ACID, POLYSORBATE 20, PPG-15 STEARYL ETHER BENZOATE, PROPYLPARABEN, PYRUS MALUS (APPLE) FRUIT EXTRACT, SACCHARUM OFFICINARUM (SUGAR CANE) EXTRACT, SODIUM ASCORBYL PHOSPHATE, TOCOPHERYL ACETATE, TRIETHOXYCAPRYLYLSILANE, WATER/EAU, XANTHAN GUM.

Questions?

OTC - QUESTIONS SECTION

450 455 9779 1 877 484 8437

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

outerouterupdated 60mL inner packagingupdated 60mL inner packaging

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67226-2231TRIPLE PROTECTION SUNSCREEN BROAD SPECTRUM SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [VIVIER PHARMA INC]9Legacy NDC20231020_1c2425da-b35a-460e-8fef-675e367ce615.zip

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67226-223167226-2231-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALUMINUM OXIDELMI26O6933IACT
AMMONIUM ACRYLOYLDIMETHYLTAURATEKBC00G95HIIACT
BUTYLPARABEN3QPI1U3FV8IACT
GREEN TEA LEAFW2ZU1RY8B0IACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
LEMON PEEL72O054U628IACT
CYCLOMETHICONENMQ347994ZIACT
DIMETHICONE92RU3N3Y1OIACT
DIPROPYLENE GLYCOL DIBENZOATE6OA5ZDY41OIACT
ETHYLPARABEN14255EXE39IACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
ISOPROPYL TITANIUM TRIISOSTEARATE949E3KBJ1IIACT
METHYLPARABENA2I8C7HI9TIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 207T1F30V5YHIACT
PPG-15 STEARYL ETHER BENZOATE80D2J6361MIACT
PROPYLPARABENZ8IX2SC1OHIACT
APPLEB423VGH5S9IACT
SUGARCANE81H2R5AOH3IACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
WATER059QF0KO0RIACT
XANTHAN GUMTTV12P4NEEIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIM

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
08171e41-8db2-67c3-e063-6394a90a0c121c2425da-b35a-460e-8fef-675e367ce6152023-10-19WarningsExact identifier
spl id: 08171e41-8db2-67c3-e063-6394a90a0c12
spl set id: 1c2425da-b35a-460e-8fef-675e367ce615

Reported adverse events (FAERS/openFDA)#

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