Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID ceffd529-92ac-c92b-e053-2a95a90a5d0d
Route
TOPICAL
Published
Effective Date 2021-10-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (5 g) Niacinamide
Inactive Ingredients
Panthenol Glycerin

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2020-04-01

Description

niacinamide, zinc oxide


Medication Information

Warnings and Precautions

For external use only.

Flammable, keep away from fire or flame.

When using this product keep out of eyes. If contact with eyes occurs, rinse promptly and thoroughly with water.

Stop use and ask a doctor if significant irritation or sensitization develops.

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 15 minutes before sun exposure.

■ Reapply at least every 2 hours.

Dosage and Administration

external use only

Description

niacinamide, zinc oxide

Section 50565-1

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6

Aloe Barbadensis Leaf Water

Propanediol

Niacinamide

Glycerin

Zinc Oxide

Cucumis Sativus (Cucumber) Fruit Water

Bambusa Vulgaris Extract

Panthenol

Centella Asiatica Extract

Anthemis Nobilis Flower Extract

Cetearyl Alcohol

1,2-Hexanediol

Cetearyl Olivate

Sorbitan Olivate

Tocopheryl Acetate

Adenosine

Euterpe Oleracea Fruit Extract

Sodium Hyaluronate

Citric Acid

Madecassoside

Madecassic Acid

Asiaticoside

Calophyllum Tacamahaca Seed Extract

Houttuynia Cordata Extract

Olea Europaea (Olive) Leaf Extract

Ocimum Basilicum (Basil) Leaf Extract

Opuntia Ficus-Indica Extract

Nelumbium Speciosum Flower Extract

Hamamelis Virginiana (Witch Hazel) Leaf Extract

Hyaluronic Acid

Hydroxydecyl Ubiquinone

Anemarrhena Asphodeloides Root Extract

Collagen Extract

rh-Oligopeptide-1

Section 51945-4

Section 55105-1

Helps prevent sunburn

Section 55106-9

niacinamide, zinc oxide


Structured Label Content

Indications and Usage (34067-9)

■ Apply liberally 15 15 minutes before sun exposure.

■ Reapply at least every 2 hours.

Dosage and Administration (34068-7)

external use only

Warnings and Precautions (34071-1)

For external use only.

Flammable, keep away from fire or flame.

When using this product keep out of eyes. If contact with eyes occurs, rinse promptly and thoroughly with water.

Stop use and ask a doctor if significant irritation or sensitization develops.

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 THE CHILDREN

Section 51727-6 (51727-6)

Aloe Barbadensis Leaf Water

Propanediol

Niacinamide

Glycerin

Zinc Oxide

Cucumis Sativus (Cucumber) Fruit Water

Bambusa Vulgaris Extract

Panthenol

Centella Asiatica Extract

Anthemis Nobilis Flower Extract

Cetearyl Alcohol

1,2-Hexanediol

Cetearyl Olivate

Sorbitan Olivate

Tocopheryl Acetate

Adenosine

Euterpe Oleracea Fruit Extract

Sodium Hyaluronate

Citric Acid

Madecassoside

Madecassic Acid

Asiaticoside

Calophyllum Tacamahaca Seed Extract

Houttuynia Cordata Extract

Olea Europaea (Olive) Leaf Extract

Ocimum Basilicum (Basil) Leaf Extract

Opuntia Ficus-Indica Extract

Nelumbium Speciosum Flower Extract

Hamamelis Virginiana (Witch Hazel) Leaf Extract

Hyaluronic Acid

Hydroxydecyl Ubiquinone

Anemarrhena Asphodeloides Root Extract

Collagen Extract

rh-Oligopeptide-1

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Helps prevent sunburn

Section 55106-9 (55106-9)

niacinamide, zinc oxide


Advanced Ingredient Data


Raw Label Data

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