34f9688d-efa1-1d3f-e063-6294a90ab127

SPL v1
SPL
SPL Set ID 34f9688d-efa1-1d3f-e063-6294a90ab127
Route
topical
Published
Effective Date 2025-05-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (11.1 g)
Inactive Ingredients
coco-caprylate/caprate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-05-30

Description

• 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


Medication Information

Warnings and Precautions

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

• apply liberally 15 minutes before sun exposure

• reapply:

– after 80 minutes of swimming or sweating

– immediately after towel drying

– at least every 2 hours

• children under 6 months: Ask a doctor

Dosage and Administration

• 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

Description

• 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

Section 50565-1

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

Section 51727-6

*Pyrus Pyrifolia (Pear) Fruit Extract, *Lentinus Edodes Extract, △Coco-Caprylate/Caprate, **Sorbitan Olivate, **Polyglyceryl-2 Dipolyhydroxystearate, △Polyglyceryl-3 Polyricinoleate, *Copernicia Cerifera (Carnauba) Wax, **Cetearyl Alcohol, Chamaecyparis Obtusa Leaf Extract, **Polyhydroxystearic Acid, △Isostearic Acid, *Calendula Officinalis Flower Oil, Pyrus Communis (Pear) Flower Extract, *Vitis Vinifera (Grape) Seed Oil, **Cetyl Alcohol, Paeonia Suffruticosa Root Extract, Scutellaria Baicalensis Root Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Tuber Magnatum Extract, Inonotus Obliquus (Mushroom) Extract, Hericium Erinaceum (Mushroom) Extract, *Lactobacillus/Pear Juice Ferment Filtrate, *Persea Gratissima (Avocado) Butter, *Theobroma Cacao (Cocoa) Seed Butter, Propanediol, *Lactobacillus Plantarum/Pyrus Communis (Pear) Fruit/Pyrus Communis (Pear) Flower Ferment Filtrate, Pimpinella Anisum (Anise) Fruit Extract, Vanilla Planifolia Fruit Extract, Pyrus Malus (Apple) Fruit Extract, Cocos Nucifera (Coconut) Oil, Rosa Damascena Flower Aqua(Water/Eau), Hedera Helix (Ivy) Leaf/Stem Extract, Musa Sapientum (Banana) Flower Extract, Asiatic Acid, Aqua(Water/Eau), Alcohol, Madecassic Acid, Asiaticoside, Fragaria Chiloensis (Strawberry) Fruit Extract. (*Certified Organically Grown **Natural Origin △Ecocert ) / 54% Organic of Total

Section 51945-4

Section 55105-1

• 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


Structured Label Content

Warnings and Precautions (34071-1)

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 (34067-9)

• apply liberally 15 minutes before sun exposure

• reapply:

– after 80 minutes of swimming or sweating

– immediately after towel drying

– at least every 2 hours

• children under 6 months: Ask a doctor

Dosage and Administration (34068-7)

• 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

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

*Pyrus Pyrifolia (Pear) Fruit Extract, *Lentinus Edodes Extract, △Coco-Caprylate/Caprate, **Sorbitan Olivate, **Polyglyceryl-2 Dipolyhydroxystearate, △Polyglyceryl-3 Polyricinoleate, *Copernicia Cerifera (Carnauba) Wax, **Cetearyl Alcohol, Chamaecyparis Obtusa Leaf Extract, **Polyhydroxystearic Acid, △Isostearic Acid, *Calendula Officinalis Flower Oil, Pyrus Communis (Pear) Flower Extract, *Vitis Vinifera (Grape) Seed Oil, **Cetyl Alcohol, Paeonia Suffruticosa Root Extract, Scutellaria Baicalensis Root Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Tuber Magnatum Extract, Inonotus Obliquus (Mushroom) Extract, Hericium Erinaceum (Mushroom) Extract, *Lactobacillus/Pear Juice Ferment Filtrate, *Persea Gratissima (Avocado) Butter, *Theobroma Cacao (Cocoa) Seed Butter, Propanediol, *Lactobacillus Plantarum/Pyrus Communis (Pear) Fruit/Pyrus Communis (Pear) Flower Ferment Filtrate, Pimpinella Anisum (Anise) Fruit Extract, Vanilla Planifolia Fruit Extract, Pyrus Malus (Apple) Fruit Extract, Cocos Nucifera (Coconut) Oil, Rosa Damascena Flower Aqua(Water/Eau), Hedera Helix (Ivy) Leaf/Stem Extract, Musa Sapientum (Banana) Flower Extract, Asiatic Acid, Aqua(Water/Eau), Alcohol, Madecassic Acid, Asiaticoside, Fragaria Chiloensis (Strawberry) Fruit Extract. (*Certified Organically Grown **Natural Origin △Ecocert ) / 54% Organic of Total

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

• 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


Advanced Ingredient Data


Raw Label Data

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