SPL v1
SPL
SPL Set ID 2ce06566-2eb0-9a00-e063-6394a90a9ba9
Route
TOPICAL
Published
Effective Date 2024-12-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (188 mg)
Inactive Ingredients
Polyhydroxystearic Acid (2300 Mw) Citric Acid Monohydrate Dunaliella Salina Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) Karum Seed Oil Squalane Chimyl Alcohol Persea Gratissima (avocado) Oil Sclerotium Gum Cocos Nucifera (coconut) Fruit Juice Xanthan Gum Polyglyceryl-4 Laurate Polyglyceryl-6 Laurate 1,2-hexanediol C13-15 Alkane Glycerin Dimethicone Water Caprylic/capric Triglyceride Trisodium Ethylenediamine Disuccinate Tasmannia Lanceolata Leaf Isoamyl Laurate Propanediol Soybean Cucumber Hydroxyacetophenone Sorbitan Isostearate Tocopherol Naringin Hydroxyapatite Carthamus Tinctorius (safflower) Oleosomes Sodium Citrate Glyceryl Citrate/lactate/linoleate/oleate Aloe Barbadensis Leaf Juice Pongamia Pinnata Seed Phenylpropanol Magnolia Officinalis Bark Chondrus Crispus Carrageenan Sodium Hyaluronate Caprylyl Glycol Haematococcus Pluvialis

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-12-18

Description

Zinc Oxide 18.8%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 18.8%

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.

Section 50565-1

• Keep out of reach of children.

Section 50566-9

• Stop use and ask a doctor if rash occurs

Section 50567-7

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1

• Do not use on damaged or broken skin.

Section 51945-4

Section 69718-5

Purpose:

Sunscreen

Warnings:

• For external use only

Directions:

• Shake well before use.

• Apply liberally to face and body 15 minutes before sun exposure.

• Use a water resistant sunscreen if swimming or sweating.

• Reapply at least every 2 hours.

• Children under 6 months of age: ask a doctor.

• Sun Protection Measures: Spending time in the sun increases your 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 higher and other sun protection measures including:

• Limit your time in the sun, especially from 10 a.m. – 2 p.m.

• Wear long-sleeved shirts, pants, hats, and sunglasses.

Active Ingredient:

Zinc Oxide 18.8%

Inactive Ingredients:

Water (Aqua), Dimethicone, Caprylic/Capric Triglyceride, Glycerin, Squalane, C13-15 Alkane, Polyglyceryl-4 Laurate, Hydroxyapatite, Persea Gratissima (Avocado) Oil, Polyglyceryl-6 Laurate, Isoamyl Laurate, Propanediol, Polyhydroxystearic Acid, 1,2-Hexanediol, Carthamus Tinctorius (Safflower) Oleosomes, Sodium Citrate, Citric Acid, Glyceryl Citrate/Lactate/Linoleate/Oleate, Maris Limus Extract, Sclerotium Gum, Aloe Barbadensis Leaf Juice, Cocos Nucifera (Coconut) Fruit Juice, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Xanthan Gum, Glycine Soja (Soybean) Seed Extract, Magnolia Officinalis Bark Extract, Chondrus Crispus Extract, Pongamia Pinnata Seed Extract, Cucumis Sativus (Cucumber) Fruit Extract, Pongamia Glabra Seed Oil, Trisodium Ethylenediamine Disuccinate, Chimyl Alcohol, Tasmannia Lanceolata Leaf Extract, Hydroxyacetophenone, Sorbitan Isostearate, Phenylpropanol, Caprylyl Glycol, Tocopherol, Dunaliella Salina Extract, Haematococcus Pluvialis Extract, Sodium Hyaluronate, Naringin


Structured Label Content

Uses: (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.

Section 50565-1 (50565-1)

• Keep out of reach of children.

Section 50566-9 (50566-9)

• Stop use and ask a doctor if rash occurs

Section 50567-7 (50567-7)

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

• Do not use on damaged or broken skin.

Section 51945-4 (51945-4)

Section 69718-5 (69718-5)

Purpose: (PURPOSE:)

Sunscreen

Warnings: (WARNINGS:)

• For external use only

Directions: (DIRECTIONS:)

• Shake well before use.

• Apply liberally to face and body 15 minutes before sun exposure.

• Use a water resistant sunscreen if swimming or sweating.

• Reapply at least every 2 hours.

• Children under 6 months of age: ask a doctor.

• Sun Protection Measures: Spending time in the sun increases your 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 higher and other sun protection measures including:

• Limit your time in the sun, especially from 10 a.m. – 2 p.m.

• Wear long-sleeved shirts, pants, hats, and sunglasses.

Active Ingredient: (ACTIVE INGREDIENT:)

Zinc Oxide 18.8%

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Water (Aqua), Dimethicone, Caprylic/Capric Triglyceride, Glycerin, Squalane, C13-15 Alkane, Polyglyceryl-4 Laurate, Hydroxyapatite, Persea Gratissima (Avocado) Oil, Polyglyceryl-6 Laurate, Isoamyl Laurate, Propanediol, Polyhydroxystearic Acid, 1,2-Hexanediol, Carthamus Tinctorius (Safflower) Oleosomes, Sodium Citrate, Citric Acid, Glyceryl Citrate/Lactate/Linoleate/Oleate, Maris Limus Extract, Sclerotium Gum, Aloe Barbadensis Leaf Juice, Cocos Nucifera (Coconut) Fruit Juice, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Xanthan Gum, Glycine Soja (Soybean) Seed Extract, Magnolia Officinalis Bark Extract, Chondrus Crispus Extract, Pongamia Pinnata Seed Extract, Cucumis Sativus (Cucumber) Fruit Extract, Pongamia Glabra Seed Oil, Trisodium Ethylenediamine Disuccinate, Chimyl Alcohol, Tasmannia Lanceolata Leaf Extract, Hydroxyacetophenone, Sorbitan Isostearate, Phenylpropanol, Caprylyl Glycol, Tocopherol, Dunaliella Salina Extract, Haematococcus Pluvialis Extract, Sodium Hyaluronate, Naringin


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