SPL v1
SPL
SPL Set ID 48ce4ef7-e24a-4894-e063-6294a90a49c8
Route
TOPICAL
Published
Effective Date 2026-01-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (24 g)
Inactive Ingredients
Hydroxyacetophenone Butyl Acrylate/methyl Methacrylate/methacrylic Acid Copolymer (18000 Mw) Dimethicone C9-12 Alkane Isododecane Ethylhexylglycerin Water Peg-9 Polydimethylsiloxyethyl Dimethicone Isobutane Triethoxycaprylylsilane Bisabolol Ethylhexyl Palmitate Glycerin Butyloctyl Salicylate Chrysanthellum Indicum Top Gentiana Scabra Root Sodium Chloride Phenoxyethanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-20

Description

Active Ingredient Zinc Oxide 24%....... .. PurposeSunscreen


Medication Information

Warnings and Precautions

WarningsFor external use only. FLAMMABLE.Don't use near heat, flame or while smoking.Do not use on damaged or broken skin.When using this product .keep out of eye. Rinse with water to remove. Keep away form face to avoid breathing it. .Use only as directed. .Don't puncture or incinerate. Contents underpressure..Don't store at temperatures above 120F(49C).

Indications and Usage

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 protection measures including:. Limit time in the sun,especially from 10 a.m. - 2 p.m..Wear long-sleeve shirts,pants, hats, and sunglasses.

Dosage and Administration

hake well before use. .Hold container 4 to 6 inches from the skin to apply.-Don't spray directly into face. Spray into hands then apply to face. .Apply liberally to exposed areas 15 minutes before sun exposure. Reapply at least every two hours, after 80 minutes of swimming or sweating, or immediately after towel-drying

Description

Active Ingredient Zinc Oxide 24%....... .. PurposeSunscreen

Section 50565-1

Keep out of reach of children, if swallowed, get medical help or contact a Poison Control center right away.

Section 51727-6

Inactive Ingredients: Water (Aqua), Chrysanthellum Indicum Extract, Isobutane,Triethoxycaprylylsilane, Dimethicone, Ethylhexyl Palmitate,Gentiana Scabra Root Extract, Isododecane, Glycerin, C9-12 Alkane, Acrylates Copolymer, Butyloctyl Salicylate, PEG-9 Polydimethylsiloxyethyl Dimethicone, Sodium Chloride,Phenoxyethanol, Ethylhexylglycerin, Bisabolol, ButyleneGlycol, Hydroxyacetophenone.

Section 51945-4

Section 55105-1

Uses

Helps prevent sunburn.If used as directed with other sun protection measures(SeeDirections), decresses the risk of skin cancer and early skin aging caused by the sun.

Section 55106-9

Active Ingredient

Zinc Oxide 24%.......

..

PurposeSunscreen


Structured Label Content

Indications and Usage (34067-9)

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 protection measures including:. Limit time in the sun,especially from 10 a.m. - 2 p.m..Wear long-sleeve shirts,pants, hats, and sunglasses.

Dosage and Administration (34068-7)

hake well before use. .Hold container 4 to 6 inches from the skin to apply.-Don't spray directly into face. Spray into hands then apply to face. .Apply liberally to exposed areas 15 minutes before sun exposure. Reapply at least every two hours, after 80 minutes of swimming or sweating, or immediately after towel-drying

Warnings and Precautions (34071-1)

WarningsFor external use only. FLAMMABLE.Don't use near heat, flame or while smoking.Do not use on damaged or broken skin.When using this product .keep out of eye. Rinse with water to remove. Keep away form face to avoid breathing it. .Use only as directed. .Don't puncture or incinerate. Contents underpressure..Don't store at temperatures above 120F(49C).

Section 50565-1 (50565-1)

Keep out of reach of children, if swallowed, get medical help or contact a Poison Control center right away.

Section 51727-6 (51727-6)

Inactive Ingredients: Water (Aqua), Chrysanthellum Indicum Extract, Isobutane,Triethoxycaprylylsilane, Dimethicone, Ethylhexyl Palmitate,Gentiana Scabra Root Extract, Isododecane, Glycerin, C9-12 Alkane, Acrylates Copolymer, Butyloctyl Salicylate, PEG-9 Polydimethylsiloxyethyl Dimethicone, Sodium Chloride,Phenoxyethanol, Ethylhexylglycerin, Bisabolol, ButyleneGlycol, Hydroxyacetophenone.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Uses

Helps prevent sunburn.If used as directed with other sun protection measures(SeeDirections), decresses the risk of skin cancer and early skin aging caused by the sun.

Section 55106-9 (55106-9)

Active Ingredient

Zinc Oxide 24%.......

..

PurposeSunscreen


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)