MYCHELLE SUN SHIELD LIQUID SPF 50 LIGHT/MEDIUM- zinc oxide liquid 
Bell International Laboratories, 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.

----------

MyChelle Sun Shield Liquid SPF 50 Light/Medium

Zinc Oxide 20.0%

Sunscreen

Uses

Helps prevent sunburn.

If used as directed with other sun protection measures (see DIRECTIONS), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only.

Do not use on damaged or broken skin.

When using this product keep out of eyes.

Rinse with water to remove. Stop use and ask a doctor if rash and irritation develops and lasts.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

SHAKE WELL BEFORE USE.
For daily use, apply to clean, dry skin and allow to absorb completely before applying makeup.
Apply liberally and evenly 15 minutes before sun exposure.
Use a water resistant sunscreen if swimming or sweating.
Reapply 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 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-sleeve shirts, pants, hats and sunglasses.
Children under 6 months: Ask a doctor.

Inactive Ingredients

Agave Tequilana Leaf Extract, Bentonite, Bisabolol, Butyloctyl Salicylate, Caprylhydroxamic Acid, Capryloyl Glycerin/Sebacic Acid Copolymer, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Oleosomes, Cetearyl Alcohol, Coco-Glucoside, Diheptyl Succinate,Ethyl Ferulate, Glycerin, Hydrolyzed Wheat Protein / PVP Crosspolymer,Iron Oxides, Jojoba Esters, Maltose, Octyldodecanol, Sodium Gluconate, Tocopherol, Trihydroxystearin, Water

Other Information

Protect this product from excessive heat and direct sun.

May stain some fabrics.

Bottle Label

Bottle Label

Package Box

Package Box

MYCHELLE SUN SHIELD LIQUID SPF 50 LIGHT/MEDIUM 
zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76150-331
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
LEVOMENOL (UNII: 24WE03BX2T)  
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
SODIUM GLUCONATE (UNII: R6Q3791S76)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
AGAVE TEQUILANA LEAF (UNII: 05545M0E3M)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
COCO GLUCOSIDE (UNII: ICS790225B)  
DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)  
ETHYL FERULATE (UNII: 5B8915UELW)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)  
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)  
MALTOSE, UNSPECIFIED FORM (UNII: XJ6S9RV06F)  
BENTONITE (UNII: A3N5ZCN45C)  
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)  
TOCOPHEROL (UNII: R0ZB2556P8)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76150-331-6830 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product01/20/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/20/2022
Labeler - Bell International Laboratories, Inc (967781555)

Revised: 1/2022
Document Id: d605f11c-4e8a-d1e5-e053-2995a90a787e
Set id: d605f11c-4e89-d1e5-e053-2995a90a787e
Version: 1
Effective Time: 20220120
 
Bell International Laboratories, Inc