3a10657a-bc16-181d-e063-6294a90a485b

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

Purpose

Sunscreen

Description

Zinc Oxide - 20%


Medication Information

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.

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





.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

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

Description

Zinc Oxide - 20%

Section 51945-4

Active Ingredients

Zinc Oxide - 20%

Questions Or Comments?

Call 1-855-280-7854

Keep Out of Reach of Children

Keep out of reach of children


Structured Label Content

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.

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





.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

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

Section 51945-4 (51945-4)

Active Ingredients

Zinc Oxide - 20%

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)