FDA.reportPublic FDA data

PRISME PRIMER Color Correcting Primer SPF 20 PA

Manufacturer
LVMH Fragrance Brands
Effective date
2023-11-06
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:21:58

Label at a glance#

ProductPRISME PRIMER Color Correcting Primer SPF 20 PA Shade 03 JAUNE
Active ingredientOCTINOXATE, TITANIUM DIOXIDE
Label structure8 sections

Dosage and administration

Apply liberally 15 minutes before sun exposure Reapply at least every 2 hours Use a water resistant sunscreen if swimming or sweating Spending time in the sun increases your risk of skin cancer and early skin aging. To decreases this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: Sun Protection Measures.  limit time in the sun, especially fro...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 4.00 %

Titanium Dioxide 2.37 %

Purpose

OTC - PURPOSE SECTION

Sunscreen

Use

INDICATIONS & USAGE SECTION

  • helps prevent sunburn if used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun Directions

For external use only

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • on damaged or broken skin

undefined

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure
  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating
  • Spending time in the sun increases your risk of skin cancer and early skin aging. To decreases this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: Sun Protection Measures. 
  • limit time in the sun, especially from 10 a.m. - 2 p.m.
  • wear long-sleeve shirts, pants, hats and sunglasses
  •  Children under 6 months of age: ask a doctor

Other information

SPL UNCLASSIFIED SECTION

  • Protect the product in this container from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

aqua (water), cyclopentasiloxane, butylene glycol, alcohol, cetyl peg/ppg-10/1 dimethicone, phenyl trimethicone, phenoxyethanol, sorbitan sesquioleate, aluminum hydroxide, dimethicone, stearic acid, disteardimonium hectorite, sodium myristoyl glutamate, calcium gluconate, tetrasodium EDTA, parfum (fragrance), propylene carbonate, viola tricolor extract, pentylene glycol, hydrolyzed rice protein, magnesium aspartate, zinc gluconate, BHT, ethylhexylglycerin, geraniol, rosa multiflora fruit extract, magnolia obovata bark extract, copper gluconate, pentaerythrityltetra-di-t-butyl hydroxyhydrocinnamate, tocopherol. [May contain: mica, CI 77891 (titanium dioxide), CI 77492 - CI 77491 (iron oxides)].

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-855-424-8563

Monday-Friday 9am to 5pm EST

us.customerservice@lvmhfragrancebrands.com

Package Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

JAUNE 1JAUNE 1JAUNE 2JAUNE 2

Products#

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

DailyMed product names page 1 of 1 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60905-006360905-0063-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CYCLOMETHICONE 50THT5PCI0RIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
ALCOHOL3K9958V90MIACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
DIMETHICONE92RU3N3Y1OIACT
STEARIC ACID4ELV7Z65APIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
SODIUM MYRISTOYL GLUTAMATEAYU7QD893WIACT
CALCIUM GLUCONATESQE6VB453KIACT
EDETATE SODIUMMP1J8420LUIACT
PROPYLENE CARBONATE8D08K3S51EIACT
VIOLA TRICOLOR9Q24RAI43VIACT
PENTYLENE GLYCOL50C1307PZGIACT
MAGNESIUM ASPARTATER17X820ROLIACT
ZINC GLUCONATEU6WSN5SQ1ZIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GERANIOLL837108USYIACT
ROSA MULTIFLORA FRUITEZ5DSL4T27IACT
MAGNOLIA OBOVATA BARKSM9Z2LD5TKIACT
COPPER GLUCONATERV823G6G67IACT
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)255PIF62MSIACT
TOCOPHEROLR0ZB2556P8IACT
MICAV8A1AW0880IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERRIC OXIDE RED1K09F3G675IACT
OCTINOXATE4Y5P7MUD51ACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB

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
25276c56-370b-5e7d-e063-6294a90a2d0d92fa05f4-65fd-4a02-8b7d-58f4a774daa12024-10-23WarningsExact identifier
spl set id: 92fa05f4-65fd-4a02-8b7d-58f4a774daa1

Reported adverse events (FAERS/openFDA)#

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