LIONESSE OPAL SHEER SHIELD SPF 30- octinoxate, homosalate, octisalate, oxybenzone, avobenzone lotion 
LIONESSE USA INC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Lionesse Opal Sheer Shield SPF 30

Active Ingredient

Octinoxate 7.40%

Homosalate 6.20%

Octisalate 5.20%

Oxybenzone 3.10%

Avobenzone 1.50%

Purpose

Sunscreen

Uses

•
Helps prevent sunburn.

Warnings

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

Keep out of eyes.

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

Stop using this product

and ask doctor if rash or redness develops and lasts.

Keep out of reach of children.

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

Directions

•
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

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

Inactive Ingredients

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

LIONESSE®
gem skin care

OPAL SHEER SHIELD
Opal Ecran Total
SPF 30
BROAD SPECTRUM

50G / 1.7 oz

image-01

Label

LIONESSE OPAL SHEER SHIELD SPF 30 
octinoxate, homosalate, octisalate, oxybenzone, avobenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72104-843
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.4 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE6.2 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5.2 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE3.1 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
MYRISTIC ACID (UNII: 0I3V7S25AW)  
PALMITIC ACID (UNII: 2V16EO95H1)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TOCOPHEROL (UNII: R0ZB2556P8)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72104-843-121 in 1 CARTON11/15/201710/17/2019
150 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/15/201710/17/2019
Labeler - LIONESSE USA INC. (079661431)

Revised: 1/2021
Document Id: 2169073b-a115-4c27-b2c3-a9d295308233
Set id: fd0419a8-7275-42b2-b126-91735b9c0292
Version: 2
Effective Time: 20210128
 
LIONESSE USA INC.