FDA.reportPublic FDA data

ROSE SIL VOUS PLAIT SPF30 GENTLE MINERAL SUNSCREEN

Manufacturer
Everyday Group Limited
Effective date
2021-12-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:24:46

Label at a glance#

ProductROSE SIL VOUS PLAIT SPF30 GENTLE MINERAL SUNSCREEN
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure7 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 signs of aging caused by the sun

Dosage and administration

Apply liberally 15 minutes before sun exposure Reapply: After 80 minutes of swimming or sweating Immediately after towel drying  At least every 2 hours 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 th...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 11.25%

Titanium Dioxide 1.50%

Purpose

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 signs of aging caused by the sun

Warnings

WARNINGS SECTION

For external use only

Do not use 

OTC - DO NOT USE SECTION

on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

keep out of eyes, rinse with water to remove

Stop use and ask a doctor

OTC - STOP USE SECTION

if rash occurs

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 liberally 15 minutes before sun exposure
  • Reapply:
  • After 80 minutes of swimming or sweating
  • Immediately after towel drying 
  • At least every 2 hours
  • 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. to 2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Organic Aloe Barbadensis Leaf Juice, Caprylic/Capric Triglyceride, Glycerin, Cetearyl Alcohol, Coconut Alkanes, Coco-Caprylate, Cetearyl Glucoside, Cetyl Palmitate, Galactoarabinan, Rosa Centifolia Flower Extract, Lavandula Angustifolia (Lavender) Flower Extract, Camellia Sinensis (Green Tea) Leaf Extract, Sorbitan Oleate, Sorbitan Palmitate, Anhydroxylitol, Coco-Caprylate/Caprate, Xylitylglucoside, Xylitol, Glyceryl Isostearate, Polyhydroxystearic Acid, Tocopherol, Sorbitan Isostearate, Caprylyl/Capryl Glucoside, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Alumina, Jojoba Esters, Phenoxyethanol, Benzyl Alcohol.

Other information

SPL UNCLASSIFIED SECTION

Protect the product in this container from excessive heat and direct sun. Store below 86°F/30°C

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72098-00372098-003-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
GLYCERINPDC6A3C0OXIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
COCONUT ALKANES1E5KJY107TIACT
COCO-CAPRYLATE4828G836N6IACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
CETYL PALMITATE5ZA2S6B08XIACT
GALACTOARABINANSL4SX1O487IACT
ROSA CENTIFOLIA FLOWERCS4TE8FF7OIACT
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER19AH1RAF4MIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
SORBITAN MONOOLEATE06XEA2VD56IACT
SORBITAN MONOPALMITATE77K6Z421KUIACT
ANHYDROXYLITOL8XWR7NN42FIACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
XYLITYLGLUCOSIDEO0IEZ166FBIACT
XYLITOLVCQ006KQ1EIACT
GLYCERYL ISOSTEARATEHYE7O27HAOIACT
TOCOPHEROLR0ZB2556P8IACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT
CAPRYLYL/CAPRYL OLIGOGLUCOSIDEE00JL9G9K0IACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)86FQE96TZ4IACT
ALUMINUM OXIDELMI26O6933IACT
PHENOXYETHANOLHIE492ZZ3TIACT
BENZYL ALCOHOLLKG8494WBHIACT
ZINC OXIDESOI2LOH54ZACTIM
TITANIUM DIOXIDE15FIX9V2JPACTIB

Source Document#

Source XML · Source PDF

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
d2455fae-8bdf-1017-e053-2995a90ad53f043612d2-4bd3-4939-921d-de877fd649e02021-12-03WarningsExact identifier
spl id: d2455fae-8bdf-1017-e053-2995a90ad53f
spl set id: 043612d2-4bd3-4939-921d-de877fd649e0

Reported adverse events (FAERS/openFDA)#

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