SPL v1
SPL
SPL Set ID 34965587-c9b7-4066-e063-6394a90ab424
Route
TOPICAL
Published
Effective Date 2025-05-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (19.32 g)
Inactive Ingredients
Sodium Chloride Triethylhexanoin Triethoxycaprylylsilane 1,2-hexanediol Water Isododecane Houttuynia Cordata Flowering Top Butyloctyl Salicylate Cetyl Diglyceryl Tris(trimethylsiloxy)silylethyl Dimethicone (950 Mm2/s) Dipentaerythrityl Tri-polyhydroxystearate C15-19 Alkane Caprylyl Methicone Isopropyl Myristate Propanediol Disiloxane Disteardimonium Hectorite Glycerin Polyglyceryl-2 Dipolyhydroxystearate Propylheptyl Caprylate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-01

Description

Active ingredient(s) Zinc Oxide 19.32%


Medication Information

Warnings and Precautions

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 doctor if rash occurs

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

Indications and Usage

Use(s)

■ 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

Dosage and Administration

Directions

■ Apply liberally and evenly 15 minutes before sun exposure

■ Reapply at least every 2 hours

■ Use a water-resistant sunscreen if swimming or sweating

■ Children under 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 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

Description

Active ingredient(s) Zinc Oxide 19.32%

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, Butyloctyl Salicylate, Propylheptyl Caprylate, Propanediol, C15-19 Alkane, Disiloxane, Isododecane, Cetyl Diglyceryl Tris(Trimethylsiloxy)silylethyl Dimethicone, Caprylyl Methicone, Isopropyl Myristate, Sodium Chloride, Triethylhexanoin, Glycerin, Disteardimonium Hectorite, Methyl Methacrylate Crosspolymer, Polymethylsilsesquioxane, Triethoxycaprylylsilane, 1,2-Hexanediol, Dipentaerythrityl Tri-Polyhydroxystearate, Houttuynia Cordata Extract, Lauryl Dimethicone/Polyglycerin-3 Crosspolymer, Polyglyceryl-2 Dipolyhydroxystearate, Panthenol, Caprylyl Glycol, Glyceryl Caprylate, Melia Azadirachta Leaf Extract, Melia Azadirachta Flower Extract, Coccinia Indica Fruit Extract, Butylene Glycol, Amber Powder, Solanum Melongena (Eggplant) Fruit Extract, Curcuma Longa (Turmeric) Root Extract, Dipropylene Glycol, Ocimum Sanctum Leaf Extract, Corallina Officinalis Extract, Moringa Oleifera Seed Oil, Tocopherol, Sodium Citrate, Lecithin, Sodium Hyaluronate, Allantoin, Dipotassium Glycyrrhizate, Sodium PCA, Arginine, Ceramide NP, Erythritol, Asiaticoside, Madecassic Acid, Asiatic Acid, Centella Asiatica Extract, Pentylene Glycol, Octanediol

Section 51945-4

Section 53413-1

Questions

[email protected]

Section 55105-1

Purpose

Sunscreen

Section 55106-9

Active ingredient(s)

Zinc Oxide 19.32%

Section 60561-8

Other Information

■ Protect the product in this container from excessive heat and direct sun


Structured Label Content

Indications and Usage (34067-9)

Use(s)

■ 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

Dosage and Administration (34068-7)

Directions

■ Apply liberally and evenly 15 minutes before sun exposure

■ Reapply at least every 2 hours

■ Use a water-resistant sunscreen if swimming or sweating

■ Children under 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 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

Warnings and Precautions (34071-1)

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 doctor if rash occurs

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

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, Butyloctyl Salicylate, Propylheptyl Caprylate, Propanediol, C15-19 Alkane, Disiloxane, Isododecane, Cetyl Diglyceryl Tris(Trimethylsiloxy)silylethyl Dimethicone, Caprylyl Methicone, Isopropyl Myristate, Sodium Chloride, Triethylhexanoin, Glycerin, Disteardimonium Hectorite, Methyl Methacrylate Crosspolymer, Polymethylsilsesquioxane, Triethoxycaprylylsilane, 1,2-Hexanediol, Dipentaerythrityl Tri-Polyhydroxystearate, Houttuynia Cordata Extract, Lauryl Dimethicone/Polyglycerin-3 Crosspolymer, Polyglyceryl-2 Dipolyhydroxystearate, Panthenol, Caprylyl Glycol, Glyceryl Caprylate, Melia Azadirachta Leaf Extract, Melia Azadirachta Flower Extract, Coccinia Indica Fruit Extract, Butylene Glycol, Amber Powder, Solanum Melongena (Eggplant) Fruit Extract, Curcuma Longa (Turmeric) Root Extract, Dipropylene Glycol, Ocimum Sanctum Leaf Extract, Corallina Officinalis Extract, Moringa Oleifera Seed Oil, Tocopherol, Sodium Citrate, Lecithin, Sodium Hyaluronate, Allantoin, Dipotassium Glycyrrhizate, Sodium PCA, Arginine, Ceramide NP, Erythritol, Asiaticoside, Madecassic Acid, Asiatic Acid, Centella Asiatica Extract, Pentylene Glycol, Octanediol

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions

[email protected]

Section 55105-1 (55105-1)

Purpose

Sunscreen

Section 55106-9 (55106-9)

Active ingredient(s)

Zinc Oxide 19.32%

Section 60561-8 (60561-8)

Other Information

■ Protect the product in this container from excessive heat and direct sun


Advanced Ingredient Data


Raw Label Data

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