Mychelle®

Mychelle®
SPL v2
SPL
SPL Set ID a4df5ddd-1c69-431e-bd9f-45de5915dc69
Route
TOPICAL
Published
Effective Date 2022-01-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (21 g)
Inactive Ingredients
Water Arachidyl Alcohol Arachidyl Glucoside Docosanol Levomenol Butyloctyl Salicylate Shea Butter Caprylhydroxamic Acid Medium-chain Triglycerides Capryloyl Glycerin/sebacic Acid Copolymer (2000 Mpa.s) Caprylyl Glycol Carboxymethylcellulose Sodium, Unspecified Cetostearyl Alcohol Cetyl Alcohol Anhydrous Citric Acid Coco Glucoside Coconut Oil Diheptyl Succinate Glycerin Methyl Dihydroabietate Microcrystalline Cellulose Polyhydroxystearic Acid (2300 Mw) Karum Seed Oil Sodium Gluconate Hyaluronate Sodium Sodium Stearoyl Glutamate Cocoa Butter Tocopherol Undaria Pinnatifida Vanillin

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.
  • 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 21%

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

Arachidyl Alcohol, Arachidyl Glucoside, Behenyl Alcohol, Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea Butter), Caprylhydroxamic Acid, Caprylic/Capric Triglyceride, Capryloyl Glycerin/ Sebacic Acid Copolymer, Caprylyl Glycol , Cellulose Gum, Cetearyl Alcohol, Cetyl Alcohol, Citric Acid, Coco-Glucoside, Cocos Nucifera (Coconut) Oil, Diheptyl Succinate, Glycerin, Methyl Dihydroabietate, Microcrystalline Cellulose, Polyhydroxystearic Acid, Pongamia Glabra Seed Oil, Sodium Gluconate, Sodium Hyaluronate, Sodium Stearoyl Glutamate, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol, Undaria Pinnatifida Extract, Vanillin, Water

Principal Display Panel 177 Ml Tube Label

MyCHELLE®

DERMACEUTICALS

PROTECT

Replenishing Solar

Defense Body Lotion

SPF 50 Water Resistant

Broad-spectrum Protection,

Coconut Oil & Shea Butter

Moisturize & Soothe

REEF

SAFE

SAME FORMULA

NEW LOOK

clean

label

PROJECT®

CERTIFIED

6.0 fl oz/177 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.
  • 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 21%

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

Arachidyl Alcohol, Arachidyl Glucoside, Behenyl Alcohol, Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea Butter), Caprylhydroxamic Acid, Caprylic/Capric Triglyceride, Capryloyl Glycerin/ Sebacic Acid Copolymer, Caprylyl Glycol , Cellulose Gum, Cetearyl Alcohol, Cetyl Alcohol, Citric Acid, Coco-Glucoside, Cocos Nucifera (Coconut) Oil, Diheptyl Succinate, Glycerin, Methyl Dihydroabietate, Microcrystalline Cellulose, Polyhydroxystearic Acid, Pongamia Glabra Seed Oil, Sodium Gluconate, Sodium Hyaluronate, Sodium Stearoyl Glutamate, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol, Undaria Pinnatifida Extract, Vanillin, Water

Principal Display Panel 177 Ml Tube Label (PRINCIPAL DISPLAY PANEL - 177 mL Tube Label)

MyCHELLE®

DERMACEUTICALS

PROTECT

Replenishing Solar

Defense Body Lotion

SPF 50 Water Resistant

Broad-spectrum Protection,

Coconut Oil & Shea Butter

Moisturize & Soothe

REEF

SAFE

SAME FORMULA

NEW LOOK

clean

label

PROJECT®

CERTIFIED

6.0 fl oz/177 mL

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:56.587058 · Updated: 2026-03-14T23:00:10.231132