drug facts

drug facts
SPL v2
SPL
SPL Set ID d5710d48-0a4b-49a6-b6b5-9a192afccd2a
Route
topical
Published
Effective Date 2024-01-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (200 mg)
Inactive Ingredients
alkyl (c12-15) benzoate caprylhydroxamic acid caprylyl glycol cetyl peg/ppg-10/1 dimethicone (hlb 5) cyclomethicone 6 cyclomethicone 5 dimethicone 100 dimethicone crosspolymer (450000 mpa.s at 12% in cyclopentasiloxane) dimethicone/vinyl dimethicone crosspolymer (soft particle) dimethiconol (2000 cst) edetate disodium glycerin hydrogen dimethicone (20 cst) microcrystalline wax peg-10 dimethicone (600 cst) peg-30 dipolyhydroxystearate (4000 mw) polyglyceryl-4 isostearate polyhydroxystearic acid (2300 mw) polysorbate 20 sodium chloride stearyl dimethicone (400 mpa.s at 50c) tetrahexyldecyl ascorbate .alpha.-tocopherol acetate trolamine triethoxycaprylylsilane water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2022-10-01

Purpose

Sunscreen

Description

Zinc Oxide 20%


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 20%

Uses:

Helps prevent sunburn. If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early 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.

Purpose:

Sunscreen

Warnings:

For external use only. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove.

Directions:
  • Apply liberally 15 minutes before sun exposure
  • Reapply:
  • After 40 minutes of swimming or sweating
    • Immediately after towel drying
    • 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 10 am- 2 pm
  • Wear long sleeve shirts and hats and sunglasses
Other Information:
  • Protect this product from excessive heat and direct sun
  • May stain some fabrics.

FREE FROM: Chemical Sunscreens, Oils, PABA, Parabens, Fragrances

Manufactured for: Shunly Skin Care LLC Meridian, ID 83646

www.shunlyskincare.com

Active Ingredients:

Zinc Oxide 20%

Inactive Ingredients:

C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cetyl PEG/PPG 10/1 Dimethicone, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium EDTA, Glycerin, Hydrogren Dimethicone, Microcrystalline Wax, PEG-10 Dimethicone, PEG-30 Dipolyhydroxytearate, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Polysorbate 20, Sodium Chloride, Stearyl Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Triethanolamine, Triethoxycaprylylsilane, Water

Principal Display Panel – 113 G Bottle Label

shunly ®

A BOTTLE

FULL OF SKINCARE

Zn20+

SPF40 Light

Moisturizer

Broad Spectrum UV Defense

FUSION FORMULA ® with

Zinc Oxide 20% / C / E

Water Resistant (40 mins)

NET.WT. 4 oz 113 g


Structured Label Content

Uses: (USES:)

Helps prevent sunburn. If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early 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.

Purpose: (PURPOSE:)

Sunscreen

Warnings: (WARNINGS:)

For external use only. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove.

Directions: (DIRECTIONS:)
  • Apply liberally 15 minutes before sun exposure
  • Reapply:
  • After 40 minutes of swimming or sweating
    • Immediately after towel drying
    • 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 10 am- 2 pm
  • Wear long sleeve shirts and hats and sunglasses
Other Information: (OTHER INFORMATION:)
  • Protect this product from excessive heat and direct sun
  • May stain some fabrics.

FREE FROM: Chemical Sunscreens, Oils, PABA, Parabens, Fragrances

Manufactured for: Shunly Skin Care LLC Meridian, ID 83646

www.shunlyskincare.com

Active Ingredients: (ACTIVE INGREDIENTS:)

Zinc Oxide 20%

Inactive Ingredients: (INACTIVE INGREDIENTS:)

C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cetyl PEG/PPG 10/1 Dimethicone, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium EDTA, Glycerin, Hydrogren Dimethicone, Microcrystalline Wax, PEG-10 Dimethicone, PEG-30 Dipolyhydroxytearate, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Polysorbate 20, Sodium Chloride, Stearyl Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Triethanolamine, Triethoxycaprylylsilane, Water

Principal Display Panel – 113 G Bottle Label (Principal Display Panel – 113 g Bottle Label)

shunly ®

A BOTTLE

FULL OF SKINCARE

Zn20+

SPF40 Light

Moisturizer

Broad Spectrum UV Defense

FUSION FORMULA ® with

Zinc Oxide 20% / C / E

Water Resistant (40 mins)

NET.WT. 4 oz 113 g


Advanced Ingredient Data


Raw Label Data

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