Drug Facts

Drug Facts
SPL v10
SPL
SPL Set ID 7bca5947-88a3-4cb3-a6f2-9fa389d344ef
Route
TOPICAL
Published
Effective Date 2024-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (55 mg) Zinc Cation (100 mg)
Inactive Ingredients
Water Glycerin Isohexadecane Isononyl Isononanoate Dicaprylyl Ether Peg-30 Dipolyhydroxystearate Alkyl (c12-15) Benzoate Polyglyceryl-4 Isostearate Dimethicone Caprylyl Trisiloxane Acrylic Acid/ethylene Copolymer (600 Mpa.s) Medium-chain Triglycerides Triethylhexanoin Silicon Dioxide Citric Acid Monohydrate Phenoxyethanol Sodium Chloride Caprylyl Glycol Panthenol Diethylhexyl Syringylidenemalonate Aluminum Hydroxide Stearic Acid Aluminum Stearate Hyaluronate Sodium Triethoxycaprylylsilane Chlorphenesin Disteardimonium Hectorite Aluminum Oxide Polyhydroxystearic Acid (2300 Mw) Trisodium Ethylenediamine Disuccinate Tocopherol P-anisic Acid Capryloyl Salicylic Acid Xanthan Gum Propylene Carbonate Senna Alata Leaf Maltodextrin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-12-01

Description

Titanium dioxide 5.5% Zinc oxide 10%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium dioxide 5.5% Zinc oxide 10%

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 51945-4

Warnings

For external use only

Directions

For sunscreen use:

● apply generously 15 minutes before sun exposure

● reapply at least every 2 hours

● use a water resistant sunscreen after swimming or sweating

● immediately after towel drying

● at least every 2 hours

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

● children under 6 months of age: Ask a doctor

Do Not Use

on damaged or broken skin

Other Information

protect the product in this container from excessive heat and direct sun

Active Ingredients

Titanium dioxide 5.5%

Zinc oxide 10%

Inactive Ingredients

water, glycerin, isohexadecane, isononyl isononanoate, dicaprylyl ether, PEG-30 dipolyhydroxystearate, c12-15 alkyl benzoate, polyglyceryl-4 isostearate, dimethicone, caprylyl methicone, ethylene/acrylic acid copolymer, caprylic/capric triglyceride, triethylhexanoin, silica, poly c10-30 alkyl acrylate, citric acid, phenoxyethanol, sodium chloride, caprylyl glycol, panthenol, diethylhexyl syringylidenemalonate, aluminum hydroxide, stearic acid, aluminum stearate, sodium hyaluronate, triethoxycaprylylsilane, chlorphenesin, disteardimonium hectorite, alumina, polyhydroxystearic acid, trisodium ethylenediamine disuccinate, tocopherol, p-anisic acid, capryloyl salicylic acid, xanthan gum, propylene carbonate, cassia alata leaf extract, maltodextrin

Questions Or Comments?

1-888-LRP-LAB0 1-888-577-5226

Monday - Friday (9 a.m. - 5 p.m. EST)

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.


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

Section 51945-4 (51945-4)

Purpose

Sunscreen

Warnings

For external use only

Directions

For sunscreen use:

● apply generously 15 minutes before sun exposure

● reapply at least every 2 hours

● use a water resistant sunscreen after swimming or sweating

● immediately after towel drying

● at least every 2 hours

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

● children under 6 months of age: Ask a doctor

Do Not Use (Do not use)

on damaged or broken skin

Other Information (Other information)

protect the product in this container from excessive heat and direct sun

Active Ingredients (Active ingredients)

Titanium dioxide 5.5%

Zinc oxide 10%

Inactive Ingredients (Inactive ingredients)

water, glycerin, isohexadecane, isononyl isononanoate, dicaprylyl ether, PEG-30 dipolyhydroxystearate, c12-15 alkyl benzoate, polyglyceryl-4 isostearate, dimethicone, caprylyl methicone, ethylene/acrylic acid copolymer, caprylic/capric triglyceride, triethylhexanoin, silica, poly c10-30 alkyl acrylate, citric acid, phenoxyethanol, sodium chloride, caprylyl glycol, panthenol, diethylhexyl syringylidenemalonate, aluminum hydroxide, stearic acid, aluminum stearate, sodium hyaluronate, triethoxycaprylylsilane, chlorphenesin, disteardimonium hectorite, alumina, polyhydroxystearic acid, trisodium ethylenediamine disuccinate, tocopherol, p-anisic acid, capryloyl salicylic acid, xanthan gum, propylene carbonate, cassia alata leaf extract, maltodextrin

Questions Or Comments? (Questions or comments?)

1-888-LRP-LAB0 1-888-577-5226

Monday - Friday (9 a.m. - 5 p.m. EST)

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

rash occurs

Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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