SPL v1
SPL
SPL Set ID 48c9d08d-9a91-7df5-e063-6294a90a1c4a
Route
TOPICAL
Published
Effective Date 2026-01-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (48 mg)
Inactive Ingredients
Citronellol Geraniol Benzyl Benzoate Linalyl Acetate Menthol Aqua Benzyl Alcohol Hexyl Cinnamal Alpha-isomethyl Ionone Linalool Geranyl Acetate Pogostemon Cablin Oil Acetyl Cedrene Amyl Salicylate Pelargonium Graveolens Flower Oil Coumarin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2026-01-15 Until 2027-01-26

Description

Zinc Oxide 24%


Medication Information

Warnings and Precautions

Warnings For enternal use only, - Danger. Flammable. Contents under pres - De not use near fire, heat or while smoking. Do not puncture or incinerate. Store at temperatures below 120*F (48C). - De not wse on damaged or braken skin. - When using this product, keep ouf of eyes. If contact occurs, rinse thoroughly with waler. . Stop use and aak a doctor if rash occurs. + Koop out of reach of chiidren. If swailowed, get medical help or contact a Poison Contrel Center iright away. - Usn only as directed. Intentional misuse by deliberately concentrating and inhaling the comtents can be harmful or fatal.

Indications and Usage

Uses Helps prevent sunburm. .l used as directed with other sun protection measures (see Directlens), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and Administration

Twice each day,4 sprays (1ml)each time. 50 days supply

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

Directions - Shake well before sach use. Spray liberally and spread evenly by hand 15 minules before sun exppsure. • Hald contsiner 4 tp & inches from the skin to apply.Rub in. -Do not apply in windy conditions. Use in a well-vent lated area. Reapply: Atter BD minutes of swimming. sweating .or immediately after towel drying A! leust every 2 hours. . Sun Protaction Measures: Spending time in the sun incresses your risk of skin cancer and early skin aging. To decrease this risk, reggularty use a sunscreen with a Biroed Spectrum SPF velue of 15 or higher and other sun protection measures includirg: - Limil time in the sun, especially from 10 am-2 pm. -Wsar long-slesve shiris, pands, hats, and Snglascs. Children under é months: Ask a doctor

Section 50570-1

You ae under 18 years of age, Do not use it on babies and children your scalp is red.inflamed.infected, irritated, or painful

You use other medicines on the scalp.Ask a doctor before use if you hace heart disease..

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.

Section 51945-4

Section 55105-1

unscreen

Section 55106-9

Zinc Oxide 24%


Structured Label Content

Indications and Usage (34067-9)

Uses Helps prevent sunburm. .l used as directed with other sun protection measures (see Directlens), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and Administration (34068-7)

Twice each day,4 sprays (1ml)each time. 50 days supply

Warnings and Precautions (34071-1)

Warnings For enternal use only, - Danger. Flammable. Contents under pres - De not use near fire, heat or while smoking. Do not puncture or incinerate. Store at temperatures below 120*F (48C). - De not wse on damaged or braken skin. - When using this product, keep ouf of eyes. If contact occurs, rinse thoroughly with waler. . Stop use and aak a doctor if rash occurs. + Koop out of reach of chiidren. If swailowed, get medical help or contact a Poison Contrel Center iright away. - Usn only as directed. Intentional misuse by deliberately concentrating and inhaling the comtents 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)

Directions - Shake well before sach use. Spray liberally and spread evenly by hand 15 minules before sun exppsure. • Hald contsiner 4 tp & inches from the skin to apply.Rub in. -Do not apply in windy conditions. Use in a well-vent lated area. Reapply: Atter BD minutes of swimming. sweating .or immediately after towel drying A! leust every 2 hours. . Sun Protaction Measures: Spending time in the sun incresses your risk of skin cancer and early skin aging. To decrease this risk, reggularty use a sunscreen with a Biroed Spectrum SPF velue of 15 or higher and other sun protection measures includirg: - Limil time in the sun, especially from 10 am-2 pm. -Wsar long-slesve shiris, pands, hats, and Snglascs. Children under é months: Ask a doctor

Section 50570-1 (50570-1)

You ae under 18 years of age, Do not use it on babies and children your scalp is red.inflamed.infected, irritated, or painful

You use other medicines on the scalp.Ask a doctor before use if you hace heart disease..

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.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

unscreen

Section 55106-9 (55106-9)

Zinc Oxide 24%


Advanced Ingredient Data


Raw Label Data

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