DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Zinc Oxide (8.7 g)

Inactive Ingredients

.beta.-bisabolol Peg-9 Diglycidyl Ether/sodium Hyaluronate Crosspolymer Aloe Vera Whole Citrus Nobilis Cocos Nucifera Whole Leptospermum Scoparium Whole Butyloctanol Almond Oil Tocopherol Candelilla Wax Sodium Beta-sitosteryl Sulfate Helianthus Annuus Whole Helianthus Annuus Seed Wax Carthamus Tinctorius Whole Butyrospermum Parkii (shea) Butter Unsaponifiables Avocado Oil Ricinus Communis Seed Mentha Spicata Oil Cocoa Butter Schinziophyton Rautanenii Whole Helichrysum Italicum Whole Simmondsia Chinensis Seed Stevia Rebaudiana Leaf Boswellia Serrata Resin Oil Potassium Hydrolyzed Jojoba Esters Carrot Seed Oil Honey Cymbopogon Flexuosus Whole Heptyl Undecylenate Butyloctyl Salicylate Rubus Idaeus Seed Squalene

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-09-02

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

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 two hours

Children under 6 months of age: ask a doctor

Description

Active Ingredient Purpose Zinc Oxide 8.5% ........................Sunscreen

Section 44425-7

Other information • protect this product

from excessive heat and direct sun.

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 50567-7

Directions

For sunscreen use: • apply liberally 15

minutes before sun exposure • use a water

resistant sunscreen if swimming or sweating

• reapply at least every two hours

Children under 6 months of age: ask a doctor

Section 51727-6

Inactive ingredients Simmondsia chinensis

(Jojoba) Seed Oil, Heptyl Undecylenate,

Euphorbia cerifera (Candelilla) Wax, Prunus

amygdalus dulcis (Sweet Almond) Oil, Jojoba

Esters, Persea gratissima (Avocado) Oil,

Theobroma cacao (Cocoa) Seed Butter,

Butyloctyl Salicylate, Rubus idaeus (Raspberry)

Seed Oil, Butyrospermum parkii (Shea) Butter,

Daucus carota sativa (Carrot) Seed Oil,

Boswellia carterii (Frankincense) Oil,

Helichrysum italicum Flower/Leaf/Stem Oil,

Cocos nucifera (Coconut) Fruit Extract,

Helianthus annuus (Sunflower) Seed Oil,

Bisabolol, Cymbopogon flexuosus

(Lemongrass) Oil, Mentha spicata

(Spearmint) Leaf/Stem Oil, Leptospermum

scoparium (Manuka) Branch/Leaf Oil,

Schinziophyton rautanenii (Mongongo) Kernel

Oil, Stevia rebaudiana Leaf/Stem Extract,

Beta-Sitosterol, Squalene, Carthamus

tinctorius (Safflower) Seed Oil, Ricinus

communis (Castor) Seed Oil, Aloe

barbadensis (Aloe) Extract, Helianthus

annuus (Sunflower) Seed Wax, Honey,

Tocopherol, Sodium Hyaluronate, Citrus

nobilis (Mandarin Orange) Peel Oil

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Active Ingredient Purpose

Zinc Oxide 8.5% ........................Sunscreen

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 two hours

Children under 6 months of age: ask a doctor

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 44425-7 (44425-7)

Other information • protect this product

from excessive heat and direct sun.

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 50567-7 (50567-7)

Directions

For sunscreen use: • apply liberally 15

minutes before sun exposure • use a water

resistant sunscreen if swimming or sweating

• reapply at least every two hours

Children under 6 months of age: ask a doctor

Section 51727-6 (51727-6)

Inactive ingredients Simmondsia chinensis

(Jojoba) Seed Oil, Heptyl Undecylenate,

Euphorbia cerifera (Candelilla) Wax, Prunus

amygdalus dulcis (Sweet Almond) Oil, Jojoba

Esters, Persea gratissima (Avocado) Oil,

Theobroma cacao (Cocoa) Seed Butter,

Butyloctyl Salicylate, Rubus idaeus (Raspberry)

Seed Oil, Butyrospermum parkii (Shea) Butter,

Daucus carota sativa (Carrot) Seed Oil,

Boswellia carterii (Frankincense) Oil,

Helichrysum italicum Flower/Leaf/Stem Oil,

Cocos nucifera (Coconut) Fruit Extract,

Helianthus annuus (Sunflower) Seed Oil,

Bisabolol, Cymbopogon flexuosus

(Lemongrass) Oil, Mentha spicata

(Spearmint) Leaf/Stem Oil, Leptospermum

scoparium (Manuka) Branch/Leaf Oil,

Schinziophyton rautanenii (Mongongo) Kernel

Oil, Stevia rebaudiana Leaf/Stem Extract,

Beta-Sitosterol, Squalene, Carthamus

tinctorius (Safflower) Seed Oil, Ricinus

communis (Castor) Seed Oil, Aloe

barbadensis (Aloe) Extract, Helianthus

annuus (Sunflower) Seed Wax, Honey,

Tocopherol, Sodium Hyaluronate, Citrus

nobilis (Mandarin Orange) Peel Oil

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Active Ingredient Purpose

Zinc Oxide 8.5% ........................Sunscreen

Advanced Ingredient Data

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"strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HELIANTHUS ANNUUS WHOLE", "unii": "17S27ZT6KR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HELIANTHUS ANNUUS SEED WAX", "unii": "42DG15CHXV", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARTHAMUS TINCTORIUS WHOLE", "unii": "5EMV416J82", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES", "unii": "0C9AC7D6XU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "AVOCADO OIL", "unii": "6VNO72PFC1", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "RICINUS COMMUNIS SEED", "unii": "7EK4SFN1TX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MENTHA SPICATA OIL", "unii": "C3M81465G5", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "COCOA BUTTER", "unii": "512OYT1CRR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SCHINZIOPHYTON RAUTANENII WHOLE", "unii": "QZK412ZY4H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HELICHRYSUM ITALICUM WHOLE", "unii": "391Z7DAJ6V", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SIMMONDSIA CHINENSIS SEED", "unii": "D24K2Q1F6H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEVIA REBAUDIANA LEAF", "unii": "6TC6NN0876", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BOSWELLIA SERRATA RESIN OIL", "unii": "5T1XCE6K8K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POTASSIUM HYDROLYZED JOJOBA ESTERS", "unii": "CH428W5O62", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARROT SEED OIL", "unii": "595AO13F11", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HONEY", "unii": "Y9H1V576FH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CYMBOPOGON FLEXUOSUS WHOLE", "unii": "0MK18YOA5G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HEPTYL UNDECYLENATE", "unii": "W77QUB6GXO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BUTYLOCTYL SALICYLATE", "unii": "2EH13UN8D3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ZINC OXIDE", "unii": "SOI2LOH54Z", "classCode": "ACTIB", "strengthNumerator": "8.7", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "RUBUS IDAEUS SEED", "unii": "M3CL7US2ZG", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SQUALENE", "unii": "7QWM220FJH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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", "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 two hours Children under 6 months of age: ask a doctor", "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.", "44425-7": "Other information • protect this product from excessive heat and direct sun.", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if rash occurs", "50567-7": "Directions For sunscreen use: • apply liberally 15 minutes before sun exposure • use a water resistant sunscreen if swimming or sweating • reapply at least every two hours Children under 6 months of age: ask a doctor", "51727-6": "Inactive ingredients Simmondsia chinensis (Jojoba) Seed Oil, Heptyl Undecylenate, Euphorbia cerifera (Candelilla) Wax, Prunus amygdalus dulcis (Sweet Almond) Oil, Jojoba Esters, Persea gratissima (Avocado) Oil, Theobroma cacao (Cocoa) Seed Butter, Butyloctyl Salicylate, Rubus idaeus (Raspberry) Seed Oil, Butyrospermum parkii (Shea) Butter, Daucus carota sativa (Carrot) Seed Oil, Boswellia carterii (Frankincense) Oil, Helichrysum italicum Flower/Leaf/Stem Oil, Cocos nucifera (Coconut) Fruit Extract, Helianthus annuus (Sunflower) Seed Oil, Bisabolol, Cymbopogon flexuosus (Lemongrass) Oil, Mentha spicata (Spearmint) Leaf/Stem Oil, Leptospermum scoparium (Manuka) Branch/Leaf Oil, Schinziophyton rautanenii (Mongongo) Kernel Oil, Stevia rebaudiana Leaf/Stem Extract, Beta-Sitosterol, Squalene, Carthamus tinctorius (Safflower) Seed Oil, Ricinus communis (Castor) Seed Oil, Aloe barbadensis (Aloe) Extract, Helianthus annuus (Sunflower) Seed Wax, Honey, Tocopherol, Sodium Hyaluronate, Citrus nobilis (Mandarin Orange) Peel Oil", "55105-1": "Sunscreen", "55106-9": "Active Ingredient Purpose Zinc Oxide 8.5% ........................Sunscreen"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information