42f17245-92a9-3915-e063-6394a90a6817

SPL v2
SPL
SPL Set ID 42f17245-92a9-3915-e063-6394a90a6817
Route
topical
Published
Effective Date 2023-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (200 mg)
Inactive Ingredients
mica bismuth oxychloride ci 77491 peg-30 dipolyhydroxystearate hydrogen dimethicone (20 cst) peg-10 dimethicone (600 cst) caprylhydroxamic acid edetate disodium anhydrous triethoxycaprylylsilane c12-15 alkyl benzoate caprylyl glycol cetyl peg/ppg-10/1 dimethicone (hlb 4) polysorbate 20 ci 77492 dimethicone/vinyl dimethicone crosspolymer (soft particle) triethanolamine water cyclohexasiloxane glycerin ci 77499 microcrystalline wax polyglyceryl-4 isostearate tetrahexyldecyl ascorbate alpha-tocopherol acetate cyclopentasiloxane dimethicone stearyl dimethicone (400 mpa.s at 50c) dimethiconol (2000 cst) polyhydroxystearic acid (2300 mw) sodium chloride dimethicone crosspolymer

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-11-01

Purpose

SUNSCREEN

Description

Zinc Oxide 20%


Medication Information

Warnings

For external use only. Do not use on broken or damaged skin. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

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. 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 10 a.m. - 2 p.m. Wear long-sleeved shirts, pants, hats and sunglasses.

Other Information

• Protect this product from excessive heat and direct sun • May stain some fabrics

Inactive Ingredients

Bismuth Oxychloride, 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, Hydrogen Dimethicone, Iron Oxides, Mica, 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

Description

Zinc Oxide 20%

Section 51945-4

Warning

KEEP OUT OF REACH OF CHILDREN

Active Ingredients

Zinc Oxide 20%


Structured Label Content

Warnings (WARNINGS)

For external use only. Do not use on broken or damaged skin. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

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.



Purpose (PURPOSE)

SUNSCREEN

Directions (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 10 a.m. - 2 p.m. Wear long-sleeved shirts, pants, hats and sunglasses.

Other Information (OTHER INFORMATION)

• Protect this product from excessive heat and direct sun • May stain some fabrics

Inactive Ingredients (INACTIVE INGREDIENTS)

Bismuth Oxychloride, 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, Hydrogen Dimethicone, Iron Oxides, Mica, 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

Section 51945-4 (51945-4)

Warning (WARNING)

KEEP OUT OF REACH OF CHILDREN

Active Ingredients

Zinc Oxide 20%


Advanced Ingredient Data


Raw Label Data

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