Mychelle®

Mychelle®
SPL v2
SPL
SPL Set ID 6d2b0af6-e570-4085-8456-2509ebaea37c
Route
TOPICAL
Published
Effective Date 2022-01-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (12 g)
Inactive Ingredients
Water Bentonite Butyloctyl Salicylate Caprylhydroxamic Acid Medium-chain Triglycerides Caprylyl Glycol Safflower Oil Cetostearyl Alcohol Coco Glucoside Glycerin Heptyl Undecylenate Hydrogenated Jojoba Oil, Randomized Methyl Dihydroabietate 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.
Section 50566-9
  • Stop use and ask a doctor if rash and irritation develops and lasts.
Section 50567-7
  • When using this product keep out of eyes.
  • Rinse with water to remove.
Section 50570-1
  • Do not use on damaged or broken skin.
Warnings

Do not puncture or incinerate can.

  • Keep away from fire and flames.
  • For external use only.
Directions
  • SHAKE WELL BEFORE USE.
  • Spray liberally and evenly 15 minutes before sun exposure. Hold container 4 to 6 inches from skin to apply. Do not spray directly on face. Spray on hands and apply to face. Avoid inhaling or exposing others to spray.
  • 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.
Other Information
  • Protect this product from excessive heat and direct sun.
  • May stain some fabrics
Active Ingredients

Zinc Oxide 12%

Inactive Ingredients

Bentonite, Butyloctyl Salicylate, Caprylhydroxamic Acid, Caprylic/Capric Triglyceride, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Seed Oil, Cetearyl Alcohol, Coco-Glucoside, Glycerin, Heptyl Undecylenate, Jojoba Esters, Methyl Dihydroabietate, Vanillin, Water

Principal Display Panel 177 Ml Bottle Label

MyCHELLE®

DERMACEUTICALS

PROTECT

Sun Shield

Clear Spray SPF 30

Water Resistant

Broad-spectrum Protection

Mineral-Rich Bentonite Clay

& Jojoba, Condition & Balance

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.
Section 50566-9 (50566-9)
  • Stop use and ask a doctor if rash and irritation develops and lasts.
Section 50567-7 (50567-7)
  • When using this product keep out of eyes.
  • Rinse with water to remove.
Section 50570-1 (50570-1)
  • Do not use on damaged or broken skin.
Purpose

Sunscreen

Warnings

Do not puncture or incinerate can.

  • Keep away from fire and flames.
  • For external use only.
Directions
  • SHAKE WELL BEFORE USE.
  • Spray liberally and evenly 15 minutes before sun exposure. Hold container 4 to 6 inches from skin to apply. Do not spray directly on face. Spray on hands and apply to face. Avoid inhaling or exposing others to spray.
  • 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.
Other Information (Other information)
  • Protect this product from excessive heat and direct sun.
  • May stain some fabrics
Active Ingredients

Zinc Oxide 12%

Inactive Ingredients

Bentonite, Butyloctyl Salicylate, Caprylhydroxamic Acid, Caprylic/Capric Triglyceride, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Seed Oil, Cetearyl Alcohol, Coco-Glucoside, Glycerin, Heptyl Undecylenate, Jojoba Esters, Methyl Dihydroabietate, Vanillin, Water

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

MyCHELLE®

DERMACEUTICALS

PROTECT

Sun Shield

Clear Spray SPF 30

Water Resistant

Broad-spectrum Protection

Mineral-Rich Bentonite Clay

& Jojoba, Condition & Balance

REEF

SAFE

SAME FORMULA

NEW LOOK

clean

label

PROJECT®

CERTIFIED

6.0 fl oz/177 mL


Advanced Ingredient Data


Raw Label Data

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