derma e sun protection mineral

derma e sun protection mineral
SPL v1
SPL
SPL Set ID bb8e3df2-23e8-4ad0-a662-ff02d156e7b1
Route
topical
Published
Effective Date 2024-04-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (241 mg)
Inactive Ingredients
silicon dioxide mica aluminum starch octenylsuccinate triethoxycaprylylsilane magnesium stearate stearic acid ferric oxide red phenoxyethanol ferric oxide yellow .alpha.-bisabolol, (+)- .alpha.-tocopherol ethylhexylglycerin isostearyl alcohol ceramide np

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-02-26

Purpose

Sunscreen

Description

Drug Facts


Medication Information

Warnings

For external use only

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 15 minutes before sun exposure
  • Reapply throughout the day
  • Children under 6 months of age: 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 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
    • reapply at least every 2 hours
    • use a water resistant sunscreen if swimming or sweating
Other Information
  • protect this product from excessive heat and direct sun.
Inactive Ingredients

Silica, Mica, Aluminum Starch Octenyl Succinate, Triethoxyoctylsilane, Magnesium Stearate, Stearic Acid, CI 77491, Phenoxyethanol, CI 77492, Bisabolol, Tocopherol, Ethylhexylglycerin, Isostearyl Alcohol, Ceramide NP.

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if rash occurs

Section 50567-7

When using this product keep out of eyes. Rinse with water to remove.

Active Ingredients

Zinc Oxide 24.1%

Principal Display Panel 5 G Bottle Box

CLINICALLY TESTED

DERMA • E

Proven

Clean

Beauty™

• NEW & IMPROVED

NEW & IMPROVED •

DERMA • E

ESSENTIALS

Sun Protection

Mineral Powder

Zinc Oxide & Ceramides

broad spectrum UVA/UVB

translucent finish for

all skin tones

spf

30

0.16 OZ / 5 g


Structured Label Content

Warnings

For external use only

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 15 minutes before sun exposure
  • Reapply throughout the day
  • Children under 6 months of age: 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 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
    • reapply at least every 2 hours
    • use a water resistant sunscreen if swimming or sweating
Other Information (Other information)
  • protect this product from excessive heat and direct sun.
Inactive Ingredients (Inactive ingredients)

Silica, Mica, Aluminum Starch Octenyl Succinate, Triethoxyoctylsilane, Magnesium Stearate, Stearic Acid, CI 77491, Phenoxyethanol, CI 77492, Bisabolol, Tocopherol, Ethylhexylglycerin, Isostearyl Alcohol, Ceramide NP.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

If product is 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 occurs

Section 50567-7 (50567-7)

When using this product keep out of eyes. Rinse with water to remove.

Active Ingredients

Zinc Oxide 24.1%

Principal Display Panel 5 G Bottle Box (PRINCIPAL DISPLAY PANEL - 5 g Bottle Box)

CLINICALLY TESTED

DERMA • E

Proven

Clean

Beauty™

• NEW & IMPROVED

NEW & IMPROVED •

DERMA • E

ESSENTIALS

Sun Protection

Mineral Powder

Zinc Oxide & Ceramides

broad spectrum UVA/UVB

translucent finish for

all skin tones

spf

30

0.16 OZ / 5 g


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)