Label: MYCHELLE DERMACEUTICALS SUN SHIELD NON-TINTED SPF 50 BROAD SPECTRUM- zinc oxide liquid
-
Contains inactivated NDC Code(s)
NDC Code(s): 72805-080-30, 72805-080-31 - Packager: French Transit, Ltd.
- 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 September 9, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
-
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
-
Directions
- SHAKE WELL BEFORE USE.
- For daily use, apply to clean, dry skin and allow to absorb completely before applying make-up.
- Apply liberally 15 minutes before sun exposure.
- Reapply After 80 minutes of swimming or sweating.
- Immediately after towel drying. At least every 2 hours.
- Children under 6 months: ask a doctor.
- 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.
-
Inactive Ingredients
Bentonite, Bisabolol, Butyloctyl Salicylate, Caprylhydroxamic Acid, Capryloyl Glycerin/Sebacic Acid Copolymer, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Oleosomes, Cetearyl Alcohol, Citric Acid, Diheptyl Succinate, Galactoarabinan, Glycerin, Glyceryl Caprylate, Glyceryl Stearate Citrate, Jojoba Esters, Polyhydroxystearic Acid, Rubus Idaeus (Raspberry) Seed Oil, Sodium Stearoyl Glutamate, Tocopherol, Water
- Other Information
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box
-
INGREDIENTS AND APPEARANCE
MYCHELLE DERMACEUTICALS SUN SHIELD NON-TINTED SPF 50 BROAD SPECTRUM
zinc oxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72805-080 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 20.5 g in 100 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Bentonite (UNII: A3N5ZCN45C) Levomenol (UNII: 24WE03BX2T) Butyloctyl Salicylate (UNII: 2EH13UN8D3) Caprylhydroxamic Acid (UNII: UPY805K99W) Capryloyl Glycerin/Sebacic Acid Copolymer (2000 MPA.S) (UNII: N7YC58165T) Caprylyl Glycol (UNII: 00YIU5438U) Carthamus Tinctorius Seed Oleosomes (UNII: 9S60Q72309) Cetostearyl Alcohol (UNII: 2DMT128M1S) Anhydrous Citric Acid (UNII: XF417D3PSL) Diheptyl Succinate (UNII: 057N7SS26Y) Galactoarabinan (UNII: SL4SX1O487) Glycerin (UNII: PDC6A3C0OX) Glyceryl Monocaprylate (UNII: TM2TZD4G4A) Glyceryl Stearate Citrate (UNII: WH8T92A065) Hydrogenated Jojoba Oil, Randomized (UNII: Q47ST02F58) Polyhydroxystearic Acid (2300 MW) (UNII: YXH47AOU0F) Raspberry Seed Oil (UNII: 9S8867952A) Sodium Stearoyl Glutamate (UNII: 65A9F4P024) Tocopherol (UNII: R0ZB2556P8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72805-080-30 1 in 1 BOX 11/01/2017 09/10/2019 1 30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 2 NDC:72805-080-31 1 in 1 BOX 09/10/2019 2 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/01/2017 Labeler - French Transit, Ltd. (100044380)
