Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 077399ff-decd-4d24-a939-b3727fd152ad
Route
TOPICAL
Published
Effective Date 2020-09-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (160 mg)
Inactive Ingredients
Medium-chain Triglycerides Ceramide Np Cyclomethicone 6 Cyclomethicone 5 Dimethicone 20 Dimethicone Crosspolymer (450000 Mpa.s At 12% In Cyclopentasiloxane) Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Dimethiconol (2000 Cst) Brown Iron Oxide Hydrogen Dimethicone (20 Cst) Peg-10 Dimethicone (600 Cst) Polyhydroxystearic Acid (2300 Mw) Tetrahexyldecyl Ascorbate .alpha.-tocopherol Acetate Vinyl Dimethicone/methicone Silsesquioxane Crosspolymer

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-09-01

Description

Zinc Oxide 16%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 16%

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 50565-1
  • Keep out of reach of children, if swallowed, get medical help or contact a poison control center right away.
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
  • For external use only
Directions
  • apply liberally 15 minutes before sun exposure
  • use a water resistant product if swimming or sweating
  • reapply 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 value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10am-2pm. Wear long-sleeved shirts, pants, hats, and sunglasses
Other Information
  • protect this product from excessive heat and direct sun
  • may stain some fabrics
Active Ingredients

Zinc Oxide 16%

Inactive Ingredients

Capric/Caprylic Triglyceride, Ceramide 3, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Hydrogen Dimethicone, Iron Oxide, PEG-10 Dimethicone, Polyhydroxystearic Acid, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Vinyl Dimethicone/Hydrogen Dimethicone Silsesquioxane Crosspolymer

Principal Display Panel – 1.75 Oz Carton Label

DAILY

MINERAL

SUNSCREEN

SHEER TINT

BROAD SPECTRUM

SPF 40

DERMSTORE

NET WT. 1.75 oz / 50 g


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 50565-1 (50565-1)
  • Keep out of reach of children, if swallowed, get medical help or contact a poison control center right away.
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
  • For external use only
Directions
  • apply liberally 15 minutes before sun exposure
  • use a water resistant product if swimming or sweating
  • reapply 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 value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10am-2pm. Wear long-sleeved shirts, pants, hats, and sunglasses
Other Information
  • protect this product from excessive heat and direct sun
  • may stain some fabrics
Active Ingredients

Zinc Oxide 16%

Inactive Ingredients

Capric/Caprylic Triglyceride, Ceramide 3, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Hydrogen Dimethicone, Iron Oxide, PEG-10 Dimethicone, Polyhydroxystearic Acid, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Vinyl Dimethicone/Hydrogen Dimethicone Silsesquioxane Crosspolymer

Principal Display Panel – 1.75 Oz Carton Label (Principal Display Panel – 1.75 oz Carton Label)

DAILY

MINERAL

SUNSCREEN

SHEER TINT

BROAD SPECTRUM

SPF 40

DERMSTORE

NET WT. 1.75 oz / 50 g


Advanced Ingredient Data


Raw Label Data

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