SPL v3
SPL
SPL Set ID b0cd27ee-4917-4800-bcdf-c6e14b28c1d1
Route
TOPICAL
Published
Effective Date 2024-01-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (8.22 g) Zinc Cation (5.76 g)
Inactive Ingredients
Water Butylene Glycol Cyclomethicone 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-01

Description

Titanium Dioxide 8.22% Zinc Oxide 5.76%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium Dioxide 8.22% Zinc Oxide 5.76%

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

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

Directions

• Apply liberally 15 minutes before sun exposure

• Reapply at least every 2 hours

• Use a water-resistant sunscreen if swimming or sweating

• Children under 6 months: 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 time in the sun, especially from 10 a.m. ‒ 2 p.m.

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

Active Ingredients

Titanium Dioxide 8.22%

Zinc Oxide 5.76%

Inactive Ingredients

Aqua/Water/Eau, Butylene Glycol, Cyclopentasiloxane, Isopropyl Palmitate, Almond Oil, Butylene Glycol Dicaprylate/Dicaprate, Butyloctyl Salicylate, Cetyl PEG/PPG-10/1 Dimethicone, Hexyldecyl Myristoyl Methylaminopropionate, Cyclohexasiloxane, Niacinamide, Talc, Dimethicone/Vinyl Dimethicone Crosspolymer, Dipentaerythrityl Hexahydroxystearate/Hexastearate/Hexarosinate, Hydrogenated Poly(C6-14 Olefin), Magnesium Sulfate, Phytosqualane, Polyglyceryl-4 Isostearate, Purslane Extract, Iron Oxides, Triethoxycaprylylsilane, Disteardimonium Hectorite, Caprylyl Glycol, Glyceryl Caprylate, Trihydroxystearin, Aminopropyl Dimethicone, Polymethylsisesquioxane, Fragrance (Parfum), Alumina, Tea Leaf Extract, Silica Dimethyl Silylate, Tocopheryl Acetate, Silica, Dimethicone, Marshmallow Leaf/Root Extract, Borage Extract, Lemon Balm Leaf Extract, Rosemary Extract

Keep Out of Reach of Children

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

Package Label.principal Display Panel

Structured Label Content

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

Purpose (PURPOSE)

Sunscreen

Warnings (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

Directions

• Apply liberally 15 minutes before sun exposure

• Reapply at least every 2 hours

• Use a water-resistant sunscreen if swimming or sweating

• Children under 6 months: 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 time in the sun, especially from 10 a.m. ‒ 2 p.m.

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

Active Ingredients (ACTIVE INGREDIENTS)

Titanium Dioxide 8.22%

Zinc Oxide 5.76%

Inactive Ingredients (INACTIVE INGREDIENTS)

Aqua/Water/Eau, Butylene Glycol, Cyclopentasiloxane, Isopropyl Palmitate, Almond Oil, Butylene Glycol Dicaprylate/Dicaprate, Butyloctyl Salicylate, Cetyl PEG/PPG-10/1 Dimethicone, Hexyldecyl Myristoyl Methylaminopropionate, Cyclohexasiloxane, Niacinamide, Talc, Dimethicone/Vinyl Dimethicone Crosspolymer, Dipentaerythrityl Hexahydroxystearate/Hexastearate/Hexarosinate, Hydrogenated Poly(C6-14 Olefin), Magnesium Sulfate, Phytosqualane, Polyglyceryl-4 Isostearate, Purslane Extract, Iron Oxides, Triethoxycaprylylsilane, Disteardimonium Hectorite, Caprylyl Glycol, Glyceryl Caprylate, Trihydroxystearin, Aminopropyl Dimethicone, Polymethylsisesquioxane, Fragrance (Parfum), Alumina, Tea Leaf Extract, Silica Dimethyl Silylate, Tocopheryl Acetate, Silica, Dimethicone, Marshmallow Leaf/Root Extract, Borage Extract, Lemon Balm Leaf Extract, Rosemary Extract

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

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

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

Advanced Ingredient Data


Raw Label Data

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