Mychelle®

Mychelle®
SPL v1
SPL
SPL Set ID 0821857c-d67f-4da1-af66-5e7f64cce59b
Route
TOPICAL
Published
Effective Date 2021-03-25
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.

Section 50567-7

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.

Section 50570-1

Do not use on damaged or broken skin.

Warnings

For external use only.

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 20.0%

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/Medium

Broad-spectrum

Protection, Bentonite

Clay & Safflower

Smooth & Balance

REEF

SAFE

clean

label

PROJECT®

CERTIFIED

SAME FORMULA

NEW

NAME

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.

Section 50567-7 (50567-7)

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.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin.

Purpose

Sunscreen

Warnings

For external use only.

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 20.0%

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/Medium

Broad-spectrum

Protection, Bentonite

Clay & Safflower

Smooth & Balance

REEF

SAFE

clean

label

PROJECT®

CERTIFIED

SAME FORMULA

NEW

NAME

1.0 fl oz/30 mL

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:29.116599 · Updated: 2026-03-14T22:59:28.137987