mychelle®

mychelle®
SPL v1
SPL
SPL Set ID 22c2839b-601b-4378-b36d-c41b2d1ea039
Route
topical
Published
Effective Date 2019-02-26
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 cannabis sativa seed oil candelilla wax hydrogenated jojoba oil, randomized octyldodecyl oleate gamma oryzanol avocado oil jojoba oil tocopherol

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2017-11-01

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
  • 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.
    • 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

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

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 17%

Principal Display Panel 15 G Container Box

SUN

PROTECTION

Sun Shield

Stick

SPF 50

Broad Spectrum

NON-TINTED

REEF

SAFE

WATER

RESISTANT

MyChelle®

dermaceuticals

.52 oz / 15 g


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
  • 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.
    • 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

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

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 17%

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

SUN

PROTECTION

Sun Shield

Stick

SPF 50

Broad Spectrum

NON-TINTED

REEF

SAFE

WATER

RESISTANT

MyChelle®

dermaceuticals

.52 oz / 15 g


Advanced Ingredient Data


Raw Label Data

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