Mychelle®

Mychelle®
SPL v2
SPL
SPL Set ID 798c0c1e-87fc-414b-bc77-271893b24d82
Route
TOPICAL
Published
Effective Date 2022-01-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (17 g)
Inactive Ingredients
Yellow Wax Levomenol Shea Butter Calophyllum Tacamahaca Seed Oil Cannabis Sativa Seed Oil Candelilla Wax Hydrogenated Jojoba Oil, Randomized Rice Bran Oil Oryzanol Avocado Oil Jojoba Oil Cocoa Butter Tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2020-03-01

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
  • Apply liberally and evenly 15 minutes before sun exposure.
  • Reapply:
    • After 80 minutes of swimming or sweating.
    • Immediately after towel drying
    • 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 17%

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

Beeswax, Bisabolol, Butyrospermum Parkii (Shea Butter), Calophyllum Tacamahaca Seed Oil, Cannabis Sativa Seed Oil, Euphorbia Cerifera (Candelilla) Wax, Jojoba Esters, Octyldodecyl Olivate, Oryza Sativa (Rice) Bran Oil, Oryzanol, Persea Gratissima (Avocado) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol

Principal Display Panel 15 G Container Box

MyCHELLE®

DERMACEUTICALS

PROTECT

Sun Shield

Stick SPF 50

Non-Tinted

Water Resistant

Broad-spectrum

Protection, Avocado

& Vitamin E

Moisturize & Restore

REEF

SAFE

clean

label

PROJECT®

CERTIFIED

.52 oz/15 g

SAME FORMULA

NEW

LOOK


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
  • Apply liberally and evenly 15 minutes before sun exposure.
  • Reapply:
    • After 80 minutes of swimming or sweating.
    • Immediately after towel drying
    • 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 17%

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

Beeswax, Bisabolol, Butyrospermum Parkii (Shea Butter), Calophyllum Tacamahaca Seed Oil, Cannabis Sativa Seed Oil, Euphorbia Cerifera (Candelilla) Wax, Jojoba Esters, Octyldodecyl Olivate, Oryza Sativa (Rice) Bran Oil, Oryzanol, Persea Gratissima (Avocado) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol

Principal Display Panel 15 G Container Box (PRINCIPAL DISPLAY PANEL - 15 g Container Box)

MyCHELLE®

DERMACEUTICALS

PROTECT

Sun Shield

Stick SPF 50

Non-Tinted

Water Resistant

Broad-spectrum

Protection, Avocado

& Vitamin E

Moisturize & Restore

REEF

SAFE

clean

label

PROJECT®

CERTIFIED

.52 oz/15 g

SAME FORMULA

NEW

LOOK


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)