Drug Facts

Drug Facts
SPL v6
SPL
SPL Set ID 92043136-b4de-4d0f-9c0c-21482c5a3c94
Route
TOPICAL
Published
Effective Date 2022-11-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (20 g)
Inactive Ingredients
Water Caprylyl Caprylate/caprate Glycine Butyloctyl Salicylate Glyceryl Stearate Se Polyhydroxystearic Acid (2300 Mw) Peg-100 Stearate Butylene Glycol Polyglyceryl-2 Stearate Potassium Cetyl Phosphate Cetyl Alcohol Xanthan Gum Pongamol Ethylhexylglycerin Xylitylglucoside Anhydroxylitol Alpha-tocopherol Xylitol Trisodium Ethylenediamine Disuccinate Salicylic Acid Ceramide Ng Chicory Root Pentylene Glycol Polysorbate 20

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-05

Description

Zinc Oxide 20%

Purpose

Sunscreen


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

Warnings

For external use only



Do not use on damaged or broken skin



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



Stop use and ask a docor if rash occurs



Keep out of reach of children. If swalled, get medical help or contact a Poison Control Center right away.

Directions

• apply generously 15 minutes before sun exposure

• reapply at least every 2 hours

• use a water-resistant sunscreen if swimming or sweating

• 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

• children under 6 months of age: Ask a doctor

Questions?

Call 1-888-883-5507

Other Information

• protect the product in this container from excessive

heat and direct sun

Active Ingredients

Zinc Oxide 20%

Inactive Ingredients

Water, Caprylic/Capric Triglyceride, Caprylyl Caprylate/Caprate, Glycerin, Butyloctyl Salicylate, Glyceryl Stearate, Polyhydrostearic Acid, PEG-100 Stearate, Butylene Glycol, Polyglyceryl-2 Stearate, Potassium Cetyl Phosphate, Cetyl Alcohol, Cetearyl Alcohol, Xanthan Gum, Pongamol, Saccharomyces/Xylinum/Black Tea Ferment, Ethylhexylglycerin, Xylitylglucoside, Anhydroxylitol, Tocopherol, Xylitol, Trisodium Ethylenediamine Disuccinate, Salicylic Acid, Ceramide NG, Chichorium Intybus (Chicory) Root Extract, Pentylene Glycol, Sodium Hyaluronate, Polysorbate 20

Principal Display Panel

Keep Out of Reach of Children.

Keep out of reach of children.


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

Purpose

Sunscreen

Warnings

For external use only



Do not use on damaged or broken skin



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



Stop use and ask a docor if rash occurs



Keep out of reach of children. If swalled, get medical help or contact a Poison Control Center right away.

Directions

• apply generously 15 minutes before sun exposure

• reapply at least every 2 hours

• use a water-resistant sunscreen if swimming or sweating

• 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

• children under 6 months of age: Ask a doctor

Questions?

Call 1-888-883-5507

Other Information

• protect the product in this container from excessive

heat and direct sun

Active Ingredients

Zinc Oxide 20%

Inactive Ingredients (Inactive ingredients)

Water, Caprylic/Capric Triglyceride, Caprylyl Caprylate/Caprate, Glycerin, Butyloctyl Salicylate, Glyceryl Stearate, Polyhydrostearic Acid, PEG-100 Stearate, Butylene Glycol, Polyglyceryl-2 Stearate, Potassium Cetyl Phosphate, Cetyl Alcohol, Cetearyl Alcohol, Xanthan Gum, Pongamol, Saccharomyces/Xylinum/Black Tea Ferment, Ethylhexylglycerin, Xylitylglucoside, Anhydroxylitol, Tocopherol, Xylitol, Trisodium Ethylenediamine Disuccinate, Salicylic Acid, Ceramide NG, Chichorium Intybus (Chicory) Root Extract, Pentylene Glycol, Sodium Hyaluronate, Polysorbate 20

Principal Display Panel

Keep Out of Reach of Children. (Keep out of reach of children.)

Keep out of reach of children.


Advanced Ingredient Data


Raw Label Data

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