FDA.reportPublic FDA data

Lionesse Opal Sheer Shield SPF 30

Manufacturer
LIONESSE USA INC.
Effective date
2018-02-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:03:22

Label at a glance#

ProductLionesse Opal Sheer Shield SPF 30
Active ingredientOCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONE
Label structure8 sections

Indications and uses

• Helps prevent sunburn.

Dosage and administration

• After cleansing, apply liberally and evenly 15 minutes before sun exposure. Smooth over face and neck and chest daily for optimal results. • Reapply at least every two (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 S...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.40%

Homosalate 6.20%

Octisalate 5.20%

Oxybenzone 3.10%

Avobenzone 1.50%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn.

Warnings

WARNINGS SECTION

For external use only. Do not use on damaged or broken skin.

Keep out of eyes.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If contact occurs, rinse with water. If rash or irritation develops, discontinue use and consult your physician.

Stop using this product

OTC - STOP USE SECTION

and ask doctor if rash or redness develops and lasts.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If accidental ingestion, call the Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • After cleansing, apply liberally and evenly 15 minutes before sun exposure. Smooth over face and neck and chest daily for optimal results.
  • Reapply at least every two (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 the sun, especially from 10 a.m. – 2 p.m.
    • wear long-sleeved shirts, pants, hats and sunglasses For children under 6 months of age: Ask doctor.

Other Information

OTHER SAFETY INFORMATION

Protect the product in this container from excessive heat and direct sun. Store at room temperature.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua, C12-15 Alkyl Benzoate, Glyceryl Stearate, Glycerin, Stearic Acid, Camellia Sinensis Extract, Aloe Barbadensis Leaf Extract, Diamond Powder, Retinyl Palmitate, Tocopherol, Polysorbate 60, Vegetable Oil, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, PEG-100 Stearate, Carbomer, Sodium PCA, Disodium EDTA, Triethanolamine, Phenoxyethanol, Ethylhexylglycerin, Fragrance.

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LIONESSE®
gem skin care

OPAL SHEER SHIELD
Opal Ecran Total
SPF 30
BROAD SPECTRUM

50G / 1.7 oz

image-01
image-01

Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72104-843-122021-02-01C16284748780-19d75b9d0-ed55-f424-e053-dadaa90a57ceLionesse Opal Sheer Shield SPF 30
72104-843-122020-01-31C16284748780-19d75b9d0-ed55-f424-e053-dadaa90a57ceLionesse Opal Sheer Shield SPF 30

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72104-84372104-843-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OXYBENZONE95OOS7VE0YACTIB
AVOBENZONEG63QQF2NOXACTIB
WATER059QF0KO0RIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
MYRISTIC ACID0I3V7S25AWIACT
PALMITIC ACID2V16EO95H1IACT
STEARIC ACID4ELV7Z65APIACT
TOCOPHEROLR0ZB2556P8IACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
ALOE VERA LEAFZY81Z83H0XIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
POLYSORBATE 60CAL22UVI4MIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
TROLAMINE9O3K93S3TKIACT

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
2169073b-a115-4c27-b2c3-a9d295308233fd0419a8-7275-42b2-b126-91735b9c02922021-01-28WarningsExact identifier
spl set id: fd0419a8-7275-42b2-b126-91735b9c0292

Reported adverse events (FAERS/openFDA)#

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