SPL v1
SPL
SPL Set ID 495e3266-a59f-42f7-e063-6394a90adfa3
Route
TOPICAL
Published
Effective Date 2026-01-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (48 g)
Inactive Ingredients
Phenoxyethanol Isooctane Butylene Glycol Aloe Barbadensis Leaf Juice Decyl Glucoside Sodium Chloride Dibutyl Adipate Caprylyl Glycol Ethylhexylglycerin Water Isobutane Tocopherol Zinc Gluconate Magnesium Chloride Bisabolol Glycerin Stearic Acid Calcium Gluconate Potassium Chloride Magnesium Aspartate Dipotassium Glycyrrhizate Hyaluronic Acid Copper Gluconate Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2026-01-27 Until 2027-01-29

Description

Zinc Oxide 24%


Medication Information

Warnings and Precautions

For external use only. . Danger. Flammable. Contents under pressure. . Do not use near fire, heat or while smoking. Do not puncture or incinerate. Store at temperatures below 120°F (48°C). Do not use on damaged or broken skin. . When using this product, keep out of eyes. If contact occurs, rinse thoroughly with water. 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. Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

Indications and Usage

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

Shake well before each use. Spray liberally and spread evenly by hand 15 minutes before sun exposure. Hold container 4 to 6 inches from the skin to apply.Rub in. Do not apply in windy conditions. Use in a well-ventilated area. Reapply: Reapply immediately after 80 minutes of swimming, sweating, or towel drying. Reapply 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 other sun protection measures including: . Limit time in the sun, especially from 10 a.m.-2 p.m. Wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months: Ask a doctor.

Description

Zinc Oxide 24%

Section 50565-1

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Chest pain, rapid heart beat, faintness, or dizziness occurs sudden, unexplained weight gain occurs,your hands or feet swell.

Section 50567-7

Shake well before each use. Spray liberally and spread evenly by hand 15 minutes before sun exposure. Hold container 4 to 6 inches from the skin to apply.Rub in. Do not apply in windy conditions . Use in a well-ventilated area. Reapply: Reapply immediately after 80 minutes of swimming, sweating, or towel drying. Reapply 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 other sun protection measures including : Limit time in the sun, especially from 10 a.m.-2 p.m. Wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months: Ask a doctor.

Section 50570-1

Do not use near fire, heat or while smoking. Do not puncture or incinerate. Store at temperatures below 120°F (48°C). • Do not use on damaged or broken skin. . When using this product, keep out of eyes. If contact occurs, rinse thoroughly with water

Section 51727-6

ALOE BARBADENSIS LEAF JUICE, DIBUTYL ADIPATE, ISOOCTANE, LAURYL PEG-10 TRIS(TRIMETHYLSILOXY)SILYLETHYL DIMETHICONE, POLYHYDROXYSTEARIC ACID, DECYL GLUCOSIDE, PHENOXYETHANOL, TOCOPHEROL, BISABOLOL, SILICA, BUTYLENE GLYCOL, ETHYLHEXYLGLYCERIN, DIPOTASSIUM GLYCYRRHIZATE, STEARIC ACID, PROPYLENE GLYCOL, XANTHAN GUM, OPUNTIA DILLENII EXTRACT, OPHIOPOGON JAPONICUS ROOT EXTRACT, AVENA SATIVA BRAN EXTRACT, PAEONIA ALBIFLORA ROOT EXTRACT, SCUTELLARIA BAICALENSIS ROOT EXTRACT, GREEN TEA (CAMELLIA SINENSIS)EXTRACT, WATER, HYALURONIC ACID, CAPRYLYL GLYCOL, ISOBUTANE, TOCOPHERYL ACETATE, GLYCERIN, COPPER GLUCONATE, SODIUM CHLORID, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, CALCIUM GLUCONATE, ZINC GLUCONATE, CERAMIDE, MAGNESIUM ASPARTATE.

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Zinc Oxide 24%


Structured Label Content

Indications and Usage (34067-9)

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)

Shake well before each use. Spray liberally and spread evenly by hand 15 minutes before sun exposure. Hold container 4 to 6 inches from the skin to apply.Rub in. Do not apply in windy conditions. Use in a well-ventilated area. Reapply: Reapply immediately after 80 minutes of swimming, sweating, or towel drying. Reapply 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 other sun protection measures including: . Limit time in the sun, especially from 10 a.m.-2 p.m. Wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months: Ask a doctor.

Warnings and Precautions (34071-1)

For external use only. . Danger. Flammable. Contents under pressure. . Do not use near fire, heat or while smoking. Do not puncture or incinerate. Store at temperatures below 120°F (48°C). Do not use on damaged or broken skin. . When using this product, keep out of eyes. If contact occurs, rinse thoroughly with water. 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. Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Chest pain, rapid heart beat, faintness, or dizziness occurs sudden, unexplained weight gain occurs,your hands or feet swell.

Section 50567-7 (50567-7)

Shake well before each use. Spray liberally and spread evenly by hand 15 minutes before sun exposure. Hold container 4 to 6 inches from the skin to apply.Rub in. Do not apply in windy conditions . Use in a well-ventilated area. Reapply: Reapply immediately after 80 minutes of swimming, sweating, or towel drying. Reapply 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 other sun protection measures including : Limit time in the sun, especially from 10 a.m.-2 p.m. Wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months: Ask a doctor.

Section 50570-1 (50570-1)

Do not use near fire, heat or while smoking. Do not puncture or incinerate. Store at temperatures below 120°F (48°C). • Do not use on damaged or broken skin. . When using this product, keep out of eyes. If contact occurs, rinse thoroughly with water

Section 51727-6 (51727-6)

ALOE BARBADENSIS LEAF JUICE, DIBUTYL ADIPATE, ISOOCTANE, LAURYL PEG-10 TRIS(TRIMETHYLSILOXY)SILYLETHYL DIMETHICONE, POLYHYDROXYSTEARIC ACID, DECYL GLUCOSIDE, PHENOXYETHANOL, TOCOPHEROL, BISABOLOL, SILICA, BUTYLENE GLYCOL, ETHYLHEXYLGLYCERIN, DIPOTASSIUM GLYCYRRHIZATE, STEARIC ACID, PROPYLENE GLYCOL, XANTHAN GUM, OPUNTIA DILLENII EXTRACT, OPHIOPOGON JAPONICUS ROOT EXTRACT, AVENA SATIVA BRAN EXTRACT, PAEONIA ALBIFLORA ROOT EXTRACT, SCUTELLARIA BAICALENSIS ROOT EXTRACT, GREEN TEA (CAMELLIA SINENSIS)EXTRACT, WATER, HYALURONIC ACID, CAPRYLYL GLYCOL, ISOBUTANE, TOCOPHERYL ACETATE, GLYCERIN, COPPER GLUCONATE, SODIUM CHLORID, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, CALCIUM GLUCONATE, ZINC GLUCONATE, CERAMIDE, MAGNESIUM ASPARTATE.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Zinc Oxide 24%


Advanced Ingredient Data


Raw Label Data

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