SPL v2
SPL
SPL Set ID 1a392f6b-1bb1-c49d-e063-6294a90a791d
Route
TOPICAL
Published
Effective Date 2024-06-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (20 g)
Inactive Ingredients
Undecane Diisostearoyl Polyglyceryl-3 Dimer Dilinoleate 4-(p-hydroxyphenyl)-2-butanone Sodium Citrate Tocopherol Ferric Oxide Yellow Polyglyceryl-6 Stearate Jacaranda Mimosifolia Whole Mica Triethoxycaprylylsilane Glycerin Ferric Oxide Red Triethyl Citrate Tridecane Kalanchoe Pinnata Whole Medium-chain Triglycerides Xanthan Gum Polyglyceryl-3 Diisostearate Brassica Napus Whole Jojoba Oil, Randomized Water Glucose Oxidase Squalane Magnesium Sulfate, Unspecified Form Bixa Orellana Leaf Polyhydroxystearic Acid (2300 Mw) Stearoyl Glutamic Acid Ferrosoferric Oxide Octyldodecyl Stearoyl Stearate Polyglyceryl-6 Polyricinoleate Isoamyl Laurate Stearalkonium Bentonite

Identifiers & Packaging

Pill Appearance
Color: brown
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-07

Description

Zinc Oxide 20%


Medication Information

Warnings and Precautions

For external use only. 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

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

Topical Lotion

Description

Zinc Oxide 20%

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if rash occurs.

Section 50569-3

Stop use and ask a doctor if rash occurs. Children under 6 months of age: ask a doctor

Section 51727-6

Aqua/Water/Eau, Caprylic/Capric Triglyceride, Undecane, Isoamyl Laurate, Polyglyceryl-6 Polyhydroxystearate, Tridecane, Glycerin, Magnesium Sulfate, Octyldodecyl Stearoyl Stearate, Polyglyceryl-6 Polyricinoleate,Brassica Napus Extract, Stearalkonium Bentonite, Triethyl Citrate, Diisostearoyl Polyglyceryl-3 Dimer Dilinoleate, Polyhydroxystearic Acid, Bixa Orellana Leaf Extract, Deoxyribonuclease, Glucose Oxidase, Jacaranda Mimosifolia Flower Extract, Kalanchoe Pinnata Leaf Extract, Raspberry Ketone, Sodium Citrate, Xanthan Gum, Squalane, Jojoba Esters, Polyglyceryl-3 Diisostearate, Stearoyl Glutamic Acid, Mica, Triethoxycaprylylsilane, Tocopherol, Iron Oxides

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Zinc Oxide 20%

Section 59845-8

Apply generously and evenly 15 minutes before sun exposure. Apply to all skin exposed to the sun at least every 2 hours. Reapply after 40 minutes of swimming or sweating. Children under 6 months of age: ask a doctor.

Sun Protection Measures: Spending time in the sun increases 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 highre and other sun protection measures including: limit time in the sun, especially from 10am-2pm, wear long-sleeved shirts, pants, hats, and sunglasses.

Section 60561-8

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


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)

Topical Lotion

Warnings and Precautions (34071-1)

For external use only. 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 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs.

Section 50569-3 (50569-3)

Stop use and ask a doctor if rash occurs. Children under 6 months of age: ask a doctor

Section 51727-6 (51727-6)

Aqua/Water/Eau, Caprylic/Capric Triglyceride, Undecane, Isoamyl Laurate, Polyglyceryl-6 Polyhydroxystearate, Tridecane, Glycerin, Magnesium Sulfate, Octyldodecyl Stearoyl Stearate, Polyglyceryl-6 Polyricinoleate,Brassica Napus Extract, Stearalkonium Bentonite, Triethyl Citrate, Diisostearoyl Polyglyceryl-3 Dimer Dilinoleate, Polyhydroxystearic Acid, Bixa Orellana Leaf Extract, Deoxyribonuclease, Glucose Oxidase, Jacaranda Mimosifolia Flower Extract, Kalanchoe Pinnata Leaf Extract, Raspberry Ketone, Sodium Citrate, Xanthan Gum, Squalane, Jojoba Esters, Polyglyceryl-3 Diisostearate, Stearoyl Glutamic Acid, Mica, Triethoxycaprylylsilane, Tocopherol, Iron Oxides

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Zinc Oxide 20%

Section 59845-8 (59845-8)

Apply generously and evenly 15 minutes before sun exposure. Apply to all skin exposed to the sun at least every 2 hours. Reapply after 40 minutes of swimming or sweating. Children under 6 months of age: ask a doctor.

Sun Protection Measures: Spending time in the sun increases 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 highre and other sun protection measures including: limit time in the sun, especially from 10am-2pm, wear long-sleeved shirts, pants, hats, and sunglasses.

Section 60561-8 (60561-8)

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


Advanced Ingredient Data


Raw Label Data

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