SPL v1
SPL
SPL Set ID 464e2d4e-9837-e6d5-e063-6294a90a726a
Route
TOPICAL
Published
Effective Date 2026-01-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (16.1 g)
Inactive Ingredients
Citric Acid Geranyl Acetate Macadamia Ternifolia Seed Oil Alpha-tocopherol Acetate Polyester-7 Sodium Phytate Caprylic/capric Triglyceride Palmitoyl Glycine Glyceryl Stearate Steareth-20 Cetearyl Alcohol Sodium Citrate Phenoxyethanol Sodium Hydroxide Acetyl Hexapeptide-8 Caprylyl Glycol Glutathione Palmitamide Tetramethyl Acetyloctahydronaphthalenes Triethoxycaprylylsilane Coco-caprylate/caprate Tocopherol Neopentyl Glycol Diheptanoate Sclerotium Gum Ceramide Np Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate Sorbitan Stearate Potassium Sorbate Acetic Acid Glycerin Copper Lysinate Hydroxycitronellal Limonene, (+/-)- Water Polyhydroxystearic Acid (2300 Mw) Fragrance 13576 1,2-hexanediol Linum Usitatissimum (linseed) Seed Oil Ammonium Acryloyldimethyltaurate/beheneth-25 Methacrylate Crosspolymer (52000 Mpa.s) Salvia Hispanica Seed Oil Citronellol Linalool Linalyl Acetate Benzyl Alcohol Pongamia Pinnata Seed Methyl-d-glucopyranoside Polysorbate 60 C12-15 Alkyl Benzoate Bisabolol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-06

Description

Zinc Oxide 16.1%


Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

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

Dosage and Administration

Directions

For Sunscreen Use:

■ Apply liberally 15 minutes before sun exposure.

■ Use a water resistant sunscreen if swimming or sweating.

■ Reapply at least every 2 hours.

■ Not for use on children.

■ 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

Zinc Oxide 16.1%

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if ■ rash occurs.

Section 50567-7

When using this product ■ keep out of eyes. Rinse with water to remove.

Section 50570-1

Do not use ■ on damaged or broken skin.

Section 51727-6

Water/Aqua/Eau, Caprylic/Capric Triglyceride, Polyhydroxystearic Acid,

Triethoxycaprylylsilane, Coco-Caprylate/Caprate, Tocopherol, Glycerin,

Steareth-20, Sorbitan Stearate, Cetearyl Alcohol, Polysorbate 60, C12-15

Alkyl Benzoate, Tocopheryl Acetate, Polyester-7, Neopentyl Glycol

Diheptanoate, Methylglucoside Phosphate, Copper Lysinate/Prolinate,

Palmitoyl Glycine, Bisabolol, Glyceryl Stearate, Benzyl Alcohol, Capylyl

Glycol, 1,2-Hexanediol, Linum Usitatissimum (Linseed) Seed Oil, Ammonium

Acryloyldimethyltaurate/Beheneth-25 Methacrylate Crosspolymer,

Sodium Citrate, Pongamia Pinnata Seed Extract, Salvia Hispanica Seed

Oil, Macadamia Ternifolia Seed Oil, Fragrance (Parfum), Sclerotium

Gum, Ceramide NP, Citric Acid, Phenoxyethanol, Potassium Sorbate,

Acetic Acid, Acetyl Hexapeptide-8, S-Palmitoylglutathione, Pentaerythrityl

Tetra-Di-T-Butyl Hydroxyhydrocinnamate, Sodium Hydroxide, Sodium

Phytate, Citronellol, Geranyl Acetate, Hydroxycitronellal, Limonene, Linalool,

Linalyl Acetate, Tetramethyl Acetyloctahydronaphthalenes

Section 51945-4

Section 53413-1

1-888-823-7837

Section 55105-1

Sunscreen

Section 55106-9

Zinc Oxide 16.1%

Section 60561-8

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


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

Directions

For Sunscreen Use:

■ Apply liberally 15 minutes before sun exposure.

■ Use a water resistant sunscreen if swimming or sweating.

■ Reapply at least every 2 hours.

■ Not for use on children.

■ 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)

For external use only.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if ■ rash occurs.

Section 50567-7 (50567-7)

When using this product ■ keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

Do not use ■ on damaged or broken skin.

Section 51727-6 (51727-6)

Water/Aqua/Eau, Caprylic/Capric Triglyceride, Polyhydroxystearic Acid,

Triethoxycaprylylsilane, Coco-Caprylate/Caprate, Tocopherol, Glycerin,

Steareth-20, Sorbitan Stearate, Cetearyl Alcohol, Polysorbate 60, C12-15

Alkyl Benzoate, Tocopheryl Acetate, Polyester-7, Neopentyl Glycol

Diheptanoate, Methylglucoside Phosphate, Copper Lysinate/Prolinate,

Palmitoyl Glycine, Bisabolol, Glyceryl Stearate, Benzyl Alcohol, Capylyl

Glycol, 1,2-Hexanediol, Linum Usitatissimum (Linseed) Seed Oil, Ammonium

Acryloyldimethyltaurate/Beheneth-25 Methacrylate Crosspolymer,

Sodium Citrate, Pongamia Pinnata Seed Extract, Salvia Hispanica Seed

Oil, Macadamia Ternifolia Seed Oil, Fragrance (Parfum), Sclerotium

Gum, Ceramide NP, Citric Acid, Phenoxyethanol, Potassium Sorbate,

Acetic Acid, Acetyl Hexapeptide-8, S-Palmitoylglutathione, Pentaerythrityl

Tetra-Di-T-Butyl Hydroxyhydrocinnamate, Sodium Hydroxide, Sodium

Phytate, Citronellol, Geranyl Acetate, Hydroxycitronellal, Limonene, Linalool,

Linalyl Acetate, Tetramethyl Acetyloctahydronaphthalenes

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

1-888-823-7837

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Zinc Oxide 16.1%

Section 60561-8 (60561-8)

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)