Label: MYCHELLE SUN SHIELD LIQUID SPF 50 LIGHT/MEDIUM- zinc oxide liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 76150-331-68 - Packager: Bell International Laboratories, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated January 20, 2022
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- ACTIVE INGREDIENT
- PURPOSE
- Uses
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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.
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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
- Bottle Label
- Package Box
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INGREDIENTS AND APPEARANCE
MYCHELLE SUN SHIELD LIQUID SPF 50 LIGHT/MEDIUM
zinc oxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76150-331 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 20 g in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:76150-331-68 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 01/20/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 01/20/2022 Labeler - Bell International Laboratories, Inc (967781555)