drug facts

drug facts
SPL v2
SPL
SPL Set ID a06e6393-13c5-48b9-909a-3bdf7d58cad3
Route
topical
Published
Effective Date 2024-01-22
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 2022-07-01

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 skin aging caused by the sun.

Section 50565-1

Keep out of the 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 • At least every 2 hours

Children under 6 months: Ask a doctor

Other Information:

Protect this product from excessive heat and direct sun

May stain some fabrics

Active Ingredients:

Zinc Oxide 20%

Inactive Ingredients:

C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cetyl PEG/PPG10/1 Dimethicone, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium EDTA, Glycerin, Hydrogren Dimethicone, Microcrystalline Wax, PEG-10 Dimethicone, PEG-30 Dipolyhydroxystearate, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Polysorbate 20, Sodium Chloride, Stearyl Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Triethanolamine, Triethoxycaprylylsilane, Water

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 10:00 a.m.-2:00 p.m.
  • Wear long-sleeved snirts, pants, hats, and sunglasses
Principal Display Panel – 115 G Bottle Label

CLOVE HILL

come home to clear skin

acne-safe

mineral sunscreen

spf 40 broad spectrum

water resistant (40 mins)

net wt. 4 oz /115 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 skin aging caused by the sun.

Section 50565-1 (50565-1)

Keep out of the 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 • At least every 2 hours

Children under 6 months: Ask a doctor

Other Information: (OTHER INFORMATION:)

Protect this product from excessive heat and direct sun

May stain some fabrics

Active Ingredients: (ACTIVE INGREDIENTS:)

Zinc Oxide 20%

Inactive Ingredients: (INACTIVE INGREDIENTS:)

C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cetyl PEG/PPG10/1 Dimethicone, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium EDTA, Glycerin, Hydrogren Dimethicone, Microcrystalline Wax, PEG-10 Dimethicone, PEG-30 Dipolyhydroxystearate, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Polysorbate 20, Sodium Chloride, Stearyl Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Triethanolamine, Triethoxycaprylylsilane, Water

Sun Protection Measures: (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 10:00 a.m.-2:00 p.m.
  • Wear long-sleeved snirts, pants, hats, and sunglasses
Principal Display Panel – 115 G Bottle Label (Principal Display Panel – 115 g Bottle Label)

CLOVE HILL

come home to clear skin

acne-safe

mineral sunscreen

spf 40 broad spectrum

water resistant (40 mins)

net wt. 4 oz /115 g


Advanced Ingredient Data


Raw Label Data

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