mychelle®

mychelle®
SPL v3
SPL
SPL Set ID d52ecb43-01f2-437e-be10-b7681ea81687
Route
topical
Published
Effective Date 2019-09-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (20.5 g)
Inactive Ingredients
water bentonite levomenol butyloctyl salicylate caprylhydroxamic acid capryloyl glycerin/sebacic acid copolymer (2000 mpa.s) caprylyl glycol carthamus tinctorius seed oleosomes cetostearyl alcohol anhydrous citric acid diheptyl succinate galactoarabinan glycerin glyceryl monocaprylate glyceryl stearate citrate hydrogenated jojoba oil, randomized polyhydroxystearic acid (2300 mw) raspberry seed oil sodium stearoyl glutamate tocopherol

Identifiers & Packaging

Marketing Status
otc monograph final completed Since 2017-11-01 Until 2019-09-10

Purpose

Sunscreen

Description

DRUG FACTS


Medication Information

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.

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.
Purpose

Sunscreen

Directions
  • SHAKE WELL BEFORE USE.
  • For daily use, apply to clean, dry skin and allow to absorb completely before applying make-up.
  • Apply liberally 15 minutes before sun exposure.
  • Reapply After 80 minutes of swimming or sweating.
  • Immediately after towel drying. At least every 2 hours.
  • Children under 6 months: ask a doctor.
  • 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.
Other Information
  • Protect this product from excessive heat and direct sun.
  • May stain some fabrics
Inactive Ingredients

Bentonite, Bisabolol, Butyloctyl Salicylate, Caprylhydroxamic Acid, Capryloyl Glycerin/Sebacic Acid Copolymer, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Oleosomes, Cetearyl Alcohol, Citric Acid, Diheptyl Succinate, Galactoarabinan, Glycerin, Glyceryl Caprylate, Glyceryl Stearate Citrate, Jojoba Esters, Polyhydroxystearic Acid, Rubus Idaeus (Raspberry) Seed Oil, Sodium Stearoyl Glutamate, Tocopherol, Water

Description

DRUG FACTS

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.

Active Ingredient

Zinc Oxide 20.5%

Principal Display Panel 30 Ml Bottle Box

SUN

PROTECTION

Sun Shield

Liquid

SPF 50

Broad Spectrum

NON-TINTED

MyChelle®

dermaceuticals

REEF

SAFE

1 fl oz / 30 mL


Structured Label Content

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.

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.
Purpose

Sunscreen

Directions
  • SHAKE WELL BEFORE USE.
  • For daily use, apply to clean, dry skin and allow to absorb completely before applying make-up.
  • Apply liberally 15 minutes before sun exposure.
  • Reapply After 80 minutes of swimming or sweating.
  • Immediately after towel drying. At least every 2 hours.
  • Children under 6 months: ask a doctor.
  • 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.
Other Information
  • Protect this product from excessive heat and direct sun.
  • May stain some fabrics
Inactive Ingredients

Bentonite, Bisabolol, Butyloctyl Salicylate, Caprylhydroxamic Acid, Capryloyl Glycerin/Sebacic Acid Copolymer, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Oleosomes, Cetearyl Alcohol, Citric Acid, Diheptyl Succinate, Galactoarabinan, Glycerin, Glyceryl Caprylate, Glyceryl Stearate Citrate, Jojoba Esters, Polyhydroxystearic Acid, Rubus Idaeus (Raspberry) Seed Oil, Sodium Stearoyl Glutamate, Tocopherol, Water

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.

Active Ingredient

Zinc Oxide 20.5%

Principal Display Panel 30 Ml Bottle Box (PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box)

SUN

PROTECTION

Sun Shield

Liquid

SPF 50

Broad Spectrum

NON-TINTED

MyChelle®

dermaceuticals

REEF

SAFE

1 fl oz / 30 mL


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)