Mychelle®

Mychelle®
SPL v1
SPL
SPL Set ID 291883a9-8939-433c-8347-8f3dbb2f1a4b
Route
TOPICAL
Published
Effective Date 2021-03-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (20 g)
Inactive Ingredients
Water Agave Tequilana Leaf Bentonite Levomenol Butyloctyl Salicylate Caprylhydroxamic Acid Capryloyl Glycerin/sebacic Acid Copolymer (2000 Mpa.s) Caprylyl Glycol Carthamus Tinctorius Seed Oleosomes Cetostearyl Alcohol Coco Glucoside Diheptyl Succinate Ethyl Ferulate Glycerin Hydrolyzed Wheat Protein (enzymatic; 3000 Mw) Ferric Oxide Red Hydrogenated Jojoba Oil, Randomized Maltose, Unspecified Form Octyldodecanol Sodium Gluconate Tocopherol Trihydroxystearin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2021-04-01

Description

DRUG FACTS

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

DRUG FACTS

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.
Section 42229-5

DRUG FACTS

Section 50565-1

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

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.

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.
Active Ingredient

Zinc Oxide 20%

Other Information
  • Protect this product from excessive heat and direct sun.
  • May stain some fabrics.
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

Principal Display Panel 30 Ml Bottle Box

MyCHELLE®

DERMACEUTICALS

PROTECT

Sun Shield

Liquid SPF 50

Light

Broad-spectrum

Protection, Bentonite

Clay & Safflower

Smooth & Balance

REEF

SAFE

clean

label

PROJECT®

CERTIFIED

ADVANCED FORMULA

NEW

SHADE

1.0 fl oz/30 mL


Structured Label Content

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.
Section 42229-5 (42229-5)

DRUG FACTS

Section 50565-1 (50565-1)

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

Purpose

Sunscreen

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.

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.
Active Ingredient

Zinc Oxide 20%

Other Information
  • Protect this product from excessive heat and direct sun.
  • May stain some fabrics.
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

Principal Display Panel 30 Ml Bottle Box (PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box)

MyCHELLE®

DERMACEUTICALS

PROTECT

Sun Shield

Liquid SPF 50

Light

Broad-spectrum

Protection, Bentonite

Clay & Safflower

Smooth & Balance

REEF

SAFE

clean

label

PROJECT®

CERTIFIED

ADVANCED FORMULA

NEW

SHADE

1.0 fl oz/30 mL


Advanced Ingredient Data


Raw Label Data

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