Mychelle®

Mychelle®
SPL v2
SPL
SPL Set ID 137708c6-2ed0-4670-a605-1f522ecbc00f
Route
TOPICAL
Published
Effective Date 2022-01-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (13.5 g)
Inactive Ingredients
Water Alcohol Kukui Nut Oil Docosanol Levomenol Medium-chain Triglycerides Cetostearyl Alcohol Anhydrous Citric Acid Ergothioneine Ethyl Macadamiate Glycerin Glyceryl Isostearate Glyceryl Monostearate Hamamelis Virginiana Top Water Barley Hydrogenated Palm Glycerides Hypromellose, Unspecified Hydroxypropyl Distarch Phosphate, High Amylose Corn Isodecyl Neopentanoate Lecithin, Soybean Lonicera Caprifolium Flower Lonicera Japonica Flower Macadamia Oil Malic Acid, L- Phellodendron Amurense Bark Fytic Acid Polyglyceryl-10 Pentastearate Polyhydroxystearic Acid (2300 Mw) Porphyra Umbilicalis Potassium Cetyl Phosphate Sandalwood Sodium Hydroxide Sodium Lactate Sodium Stearoyl Lactylate .alpha.-tocopherol, D- .alpha.-tocopherol Acetate, D-

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
  • SHAKE WELL BEFORE USE.
  • For daily use, apply to clean, dry skin and allow to absorb completely before applying makeup.
  • Apply liberally 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 13.5%

Other Information

Protect this product from excessive heat and direct sun.

Inactive Ingredients

Alcohol, Aleurites Moluccanus Seed Oil, Aqua (Water), Behenyl Alcohol, Bisabolol (L-alpha), Candelilla/Jojoba/Rice Bran Polyglyceryl-3 Esters, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Citric Acid, Ergothioneine (L), Ethyl Macadamiate, Glycerin, Glyceryl Isostearate, Glyceryl Stearate, Hamamelis Virginiana (Witch Hazel) Water, Hordeum Distichon (Barley) Extract, Hydrogenated Palm Glycerides, Hydroxypropyl Methylcellulose, Hydroxypropyl Starch Phosphate, Isodecyl Neopentanoate, Lecithin, Lonicera Caprifolium (Honeysuckle) Flower Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Macadamia Ternifolia Seed Oil, Malic Acid (L), Phellodendron Amurense Bark Extract, Phytic Acid, Polyglyceryl-10 Pentastearate, Polyhydroxystearic Acid, Porphyra Umbilicalis (Red Algae) Extract, Potassium Cetyl Phosphate, Santalum Album (Sandalwood) Extract, Sodium Hydroxide, Sodium Lactate, Sodium Stearoyl Lactylate, Tocopherol (D-alpha), Tocopheryl Acetate (D-alpha)

Principal Display Panel 68 Ml Tube Box

MyCHELLE®

DERMACEUTICALS

PROTECT

Replenishing

Solar Defense

SPF 30

Broad-spectrum

Protection, Red Algae

Extract & Kukui Oil

Moisturize & Soothe

REEF

SAFE

clean

label

PROJECT®

CERTIFIED

2.3 fl oz/68 mL

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
  • SHAKE WELL BEFORE USE.
  • For daily use, apply to clean, dry skin and allow to absorb completely before applying makeup.
  • Apply liberally 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 13.5%

Other Information

Protect this product from excessive heat and direct sun.

Inactive Ingredients

Alcohol, Aleurites Moluccanus Seed Oil, Aqua (Water), Behenyl Alcohol, Bisabolol (L-alpha), Candelilla/Jojoba/Rice Bran Polyglyceryl-3 Esters, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Citric Acid, Ergothioneine (L), Ethyl Macadamiate, Glycerin, Glyceryl Isostearate, Glyceryl Stearate, Hamamelis Virginiana (Witch Hazel) Water, Hordeum Distichon (Barley) Extract, Hydrogenated Palm Glycerides, Hydroxypropyl Methylcellulose, Hydroxypropyl Starch Phosphate, Isodecyl Neopentanoate, Lecithin, Lonicera Caprifolium (Honeysuckle) Flower Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Macadamia Ternifolia Seed Oil, Malic Acid (L), Phellodendron Amurense Bark Extract, Phytic Acid, Polyglyceryl-10 Pentastearate, Polyhydroxystearic Acid, Porphyra Umbilicalis (Red Algae) Extract, Potassium Cetyl Phosphate, Santalum Album (Sandalwood) Extract, Sodium Hydroxide, Sodium Lactate, Sodium Stearoyl Lactylate, Tocopherol (D-alpha), Tocopheryl Acetate (D-alpha)

Principal Display Panel 68 Ml Tube Box (PRINCIPAL DISPLAY PANEL - 68 mL Tube Box)

MyCHELLE®

DERMACEUTICALS

PROTECT

Replenishing

Solar Defense

SPF 30

Broad-spectrum

Protection, Red Algae

Extract & Kukui Oil

Moisturize & Soothe

REEF

SAFE

clean

label

PROJECT®

CERTIFIED

2.3 fl oz/68 mL

SAME FORMULA

NEW

LOOK


Advanced Ingredient Data


Raw Label Data

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