SPL v1
SPL
SPL Set ID 43013b21-b3de-6d98-e063-6394a90adb80
Route
TOPICAL
Published
Effective Date 2025-05-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (25 g)
Inactive Ingredients
Sorbitan Oleate Polysorbate 80 Propylene Glycol Butyrospermum Parkii (shea) Oil Potassium Cetyl Phosphate Water Ethylhexyl Methoxycinnamate C13-14 Isoparaffin Phenoxyethanol Steareth-20 Ethylhexylglycerin Dimethicone Edetate Disodium Xanthan Gum Aluminum Hydroxide Laureth-7 Glycerin Cetearyl Alcohol Polyacrylamide (1500 Mw) Panthenol Octisalate Steareth-2 .alpha.-tocopherol Acetate Paraffinum Liquidum Sodium Acrylate/sodium Acryloyldimethyltaurate Copolymer (4000000 Mw) Silica C12-15 Alkyl Benzoate Isohexadecane Tocopherol Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-06

Description

Non-Nano Zinc Oxide 25%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Non-Nano Zinc Oxide 25%

Use

.helps prevent sunburn

.if used as directed with other sun protectionmeasures(see Directions),decreases therisk of skin cancer and early skin agingcaused by the sun

None

none

Section 51945-4

Warning

.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 doctorif rash occurs.

.Keep out of reach of children.lf product isswallowed, get medical help or contact aPoison Control Center right away.

Directions

.apply liberally 15 minutes before sun exposure.

.reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours

children after 6 months of age: 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 of 15 or higher and other sun protection.

measures including:

-limit time in the sun, especially from10am-2pm

-wear long-sleeve shirts, pants, hats, and sunglasses

Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

Questions?
Active Ingredient

Non-Nano Zinc Oxide 25%

Inactive Ingredients

Water, Tallow, Tocopherol(vitamin E),Centella Asiatica extract, Camellia Sinensisleaf extract, Rosmarinus Officinalis leafextract,Jojoba Esters, Lecithin, CeraAlba(beeswax),Glycerin,Titanium Dioxide.Cetyl Alcohol, Dioctyl Carbonate, Silica,Polyglycerol-10 Decaoleate.


Structured Label Content

Use (use)

.helps prevent sunburn

.if used as directed with other sun protectionmeasures(see Directions),decreases therisk of skin cancer and early skin agingcaused by the sun

None (none)

none

Section 51945-4 (51945-4)

Purpose

Sunscreen

Warning

.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 doctorif rash occurs.

.Keep out of reach of children.lf product isswallowed, get medical help or contact aPoison Control Center right away.

Directions

.apply liberally 15 minutes before sun exposure.

.reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours

children after 6 months of age: 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 of 15 or higher and other sun protection.

measures including:

-limit time in the sun, especially from10am-2pm

-wear long-sleeve shirts, pants, hats, and sunglasses

Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

Questions?
Active Ingredient

Non-Nano Zinc Oxide 25%

Inactive Ingredients (Inactive ingredients)

Water, Tallow, Tocopherol(vitamin E),Centella Asiatica extract, Camellia Sinensisleaf extract, Rosmarinus Officinalis leafextract,Jojoba Esters, Lecithin, CeraAlba(beeswax),Glycerin,Titanium Dioxide.Cetyl Alcohol, Dioctyl Carbonate, Silica,Polyglycerol-10 Decaoleate.


Advanced Ingredient Data


Raw Label Data

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