![MYCHELLE DERMACEUTICALS SUN SHIELD NATURAL TAN SPF 50 BROAD SPECTRUM (ZINC OXIDE) LIQUID [FRENCH TRANSIT, LTD.]](https://medic.hrt.org//dailymed/images/57b94be7-6a35-494f-aeb4-9193a32ba5b6/shield-01.jpg)
| NDC | 72805-070-30 |
| Set ID | 57b94be7-6a35-494f-aeb4-9193a32ba5b6 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | French Transit, Ltd. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- 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 and evenly 15 minutes before sun exposure.
- Reapply:
- After 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
Agave Tequilana Leaf Extract, Bentonite, Butyloctyl Salicylate, Caprylhydroxamic Acid, Capryloyl Glycerin/Sebacic Acid Copolymer, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Oleosomes, Cetearyl Alcohol, Coco-Glucoside, Diheptyl Succinate, Glycerin, Hydrolyzed Wheat Protein / PVP Crosspolymer, Iron Oxides, Jojoba Esters, Maltose, Octyldodecanol, Sodium Gluconate, Tocopherol, Trihydroxystearin, Water
- Other Information
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box
-
INGREDIENTS AND APPEARANCE
MYCHELLE DERMACEUTICALS SUN SHIELD NATURAL TAN SPF 50 BROAD SPECTRUM
zinc oxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72805-070 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 16.1 g in 100 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Agave Tequilana Leaf (UNII: 05545M0E3M) Bentonite (UNII: A3N5ZCN45C) 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) Coco Glucoside (UNII: ICS790225B) Diheptyl Succinate (UNII: 057N7SS26Y) Glycerin (UNII: PDC6A3C0OX) Ferric Oxide Red (UNII: 1K09F3G675) Hydrogenated Jojoba Oil, Randomized (UNII: Q47ST02F58) Maltose, Unspecified Form (UNII: XJ6S9RV06F) Octyldodecanol (UNII: 461N1O614Y) Sodium Gluconate (UNII: R6Q3791S76) Tocopherol (UNII: R0ZB2556P8) Trihydroxystearin (UNII: 06YD7896S3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72805-070-30 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:72805-070-31 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)
