SPL v2
SPL
SPL Set ID 3a10657a-bc16-181d-e063-6294a90a485b
Route
TOPICAL
Published
Effective Date 2022-07-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (20 mg)
Inactive Ingredients
Sorbitan Olivate Water Coco-glucoside Vinylpyrrolidone/eicosene Copolymer Caprylic/capric Triglyceride Isostearic Acid Xanthan Gum Glycerin Polyglyceryl-3 Pentaricinoleate Cetearyl Alcohol Bentonite Polyhydroxystearic Acid (2300 Mw) Squalane Caprylhydroxamic Acid Sodium Gluconate Cetyl Palmitate Lecithin, Sunflower

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2025-08-01 Until 2026-08-01

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

Section 51945-4

Warnings



Warnings

. For external use only " Do not use on damaged or broken skin.

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

remove. . Keep away from face to avoid breathing it. . Do not puncture or

incinerate. . Contents under pressure. . Do not store at temperatures

about 120"F .. Stop use and ask a doctor if rash occurs. . Keep out of

reach of children. If product is swallowed, get medical help or contact a

Poison Control Center right away.

Directions





.Spray generously and spread evenly 15 minutes before sun exposure .

Hold container 4 to 6 inches from skin to apply. " Do not spray directly into

face. . Spray on hands then apply to face. . Do not apply in windy

conditions. . Use in well-vertilated areas. . Children under 6 months of

age: ask a doctor" reapply:" after 80 minutes of swimming or sweating"

immediately after towel drying . at least every 2 hours 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 take 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 the product in this container from

excessive heat and direct sun

Active Ingredients

Zinc Oxide - 20%

Inactive Ingredients



Water/Aqua/Eau, Caprylic/Capric Triglyceride,

Cetearyl Alcohol, Glycerin, Sorbitan Olivate, Cetyl Palmitate,

Coco-Glucoside, VP/Eicosene Copalymer, Bentonite, Polyhydroxystearic

Acid, Caprylhydroxamic Acid, Methylheptylglycerin, Polyglyceryl-3

Polyricinoleate, Isostearic Acid, Lecithin, Xanthan Gum, Squalane,

Sodium Gluconate

Questions Or Comments?

Call 1-855-280-7854

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

Section 51945-4 (51945-4)

Purpose

Sunscreen

Warnings



Warnings

. For external use only " Do not use on damaged or broken skin.

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

remove. . Keep away from face to avoid breathing it. . Do not puncture or

incinerate. . Contents under pressure. . Do not store at temperatures

about 120"F .. Stop use and ask a doctor if rash occurs. . Keep out of

reach of children. If product is swallowed, get medical help or contact a

Poison Control Center right away.

Directions





.Spray generously and spread evenly 15 minutes before sun exposure .

Hold container 4 to 6 inches from skin to apply. " Do not spray directly into

face. . Spray on hands then apply to face. . Do not apply in windy

conditions. . Use in well-vertilated areas. . Children under 6 months of

age: ask a doctor" reapply:" after 80 minutes of swimming or sweating"

immediately after towel drying . at least every 2 hours 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 take 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 the product in this container from

excessive heat and direct sun

Active Ingredients

Zinc Oxide - 20%

Inactive Ingredients



Water/Aqua/Eau, Caprylic/Capric Triglyceride,

Cetearyl Alcohol, Glycerin, Sorbitan Olivate, Cetyl Palmitate,

Coco-Glucoside, VP/Eicosene Copalymer, Bentonite, Polyhydroxystearic

Acid, Caprylhydroxamic Acid, Methylheptylglycerin, Polyglyceryl-3

Polyricinoleate, Isostearic Acid, Lecithin, Xanthan Gum, Squalane,

Sodium Gluconate

Questions Or Comments? (Questions or comments?)

Call 1-855-280-7854

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

Keep out of reach of children


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)