Sheer Tint Mineral Sunscreen Broad Spectrum Spf 50 - Light/medium Shade

Sheer Tint Mineral Sunscreen Broad Spectrum Spf 50 - Light/medium Shade
SPL v1
SPL
SPL Set ID fd6807e1-c8c0-b361-e053-6294a90aea0c
Route
TOPICAL
Published
Effective Date 2023-07-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (2.37 g) Zinc Oxide (13.35 g)
Inactive Ingredients
Laureth-12 Ferrosoferric Oxide Hyaluronate Sodium Ethylhexylglycerin Glycyrrhiza Glabra Diisopropyl Sebacate Undecane Medium-chain Triglycerides Water Polymethylsilsesquioxane (11 Microns) Isododecane Mica .alpha.-tocopherol Acetate, Dl- Aluminum Oxide Ferric Oxide Yellow Jojoba Oil .alpha.-bisabolol, (+/-)- .alpha.-tocopherol, Dl- Tridecane Polyhydroxystearic Acid (2300 Mw) Polyglyceryl-2 Isostearate Phenoxyethanol Sodium Chloride Propanediol Magnesium Stearate Edetate Disodium 1,2-hexanediol Propylene Carbonate Niacinamide Ferric Oxide Red Cyclomethicone 6 Aloe Vera Leaf Caprylhydroxamic Acid Glycerin Polyglyceryl-6 Polyricinoleate Dimethicone 100 Argania Spinosa Seed Disteardimonium Hectorite Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Triethoxycaprylylsilane

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-07-15

Description

Active Ingredient Zinc Oxide 13.3% Titanium Dioxide 2.3%


Medication Information

Warnings and Precautions

For external use only

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right awy

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

Indications and Usage

Apply generously 15 minutes before sun exposure

Reapply every 2 hours

Use a water resistant sunscreen if swimming or sweating

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 10am - 2pm,
  • Wear long-sleeved shirts, pants, hats, and sunglasses

Children under 6 months of age: Ask a doctor

Dosage and Administration

Helps prevent sunburn

Description

Active Ingredient Zinc Oxide 13.3% Titanium Dioxide 2.3%

Section 50565-1

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away

Section 51727-6

Caprylic/Capric Triglyceride, Water, Diisopropyl Sebacate, Polymethylsilsesquioxane, Undecane, Aloe Barbadensis Leaf Juice, Glycerin, Polyglyceryl-6 Polyricinoleate, Isododecane, Dimethicone, Mica, Polysilicone-11, Tridecane, Argania Spinosa Kernel Oil, Polyhydroxystearic Acid, Tocopheryl Acetate, Polyglyceryl-2 Isostearate, Disteardimonium Hectorite, Phenoxyethanol, Dimethicone Crosspolymer, Sodium Chloride, Triethoxycaprylylsilane, Alumina, Propanediol, Iron Oxide (CI 77492), Magnesium Stearate, Jojoba Esters, Disodium EDTA, 1,2-Hexanediol, Bisabolol, Propylene Carbonate, Titanium Dioxide (CI 77891), Niacinamide, Iron Oxides (CI 77491), Cyclohexasiloxane, Laureth-12, Caprylhydroxamic Acid, Iron Oxides (Black, CI 77499), Sodium Hyaluronate, Ethylhexylglycerin, Tocopherol, Glycyrrhiza Glabra (Licorice) Root Extract, Iron Oxides (CI77499).

Section 51945-4

image components

Section 53413-1

888-859-1188

Section 55105-1

Sunscreen

Section 55106-9

Active Ingredient

Zinc Oxide 13.3%

Titanium Dioxide 2.3%

Section 59845-8

Apply generously 15 minutes before sun exposure

Reapply every 2 hours

Use a water resistant sunscreen if swimming or sweating

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 10am - 2pm,
  • Wear long-sleeved shirts, pants, hats, and sunglasses

Children under 6 months of age: Ask a doctor

Section 60561-8

Store at 20-25C (68-77F)

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


Structured Label Content

Indications and Usage (34067-9)

Apply generously 15 minutes before sun exposure

Reapply every 2 hours

Use a water resistant sunscreen if swimming or sweating

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 10am - 2pm,
  • Wear long-sleeved shirts, pants, hats, and sunglasses

Children under 6 months of age: Ask a doctor

Dosage and Administration (34068-7)

Helps prevent sunburn

Warnings and Precautions (34071-1)

For external use only

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right awy

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

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away

Section 51727-6 (51727-6)

Caprylic/Capric Triglyceride, Water, Diisopropyl Sebacate, Polymethylsilsesquioxane, Undecane, Aloe Barbadensis Leaf Juice, Glycerin, Polyglyceryl-6 Polyricinoleate, Isododecane, Dimethicone, Mica, Polysilicone-11, Tridecane, Argania Spinosa Kernel Oil, Polyhydroxystearic Acid, Tocopheryl Acetate, Polyglyceryl-2 Isostearate, Disteardimonium Hectorite, Phenoxyethanol, Dimethicone Crosspolymer, Sodium Chloride, Triethoxycaprylylsilane, Alumina, Propanediol, Iron Oxide (CI 77492), Magnesium Stearate, Jojoba Esters, Disodium EDTA, 1,2-Hexanediol, Bisabolol, Propylene Carbonate, Titanium Dioxide (CI 77891), Niacinamide, Iron Oxides (CI 77491), Cyclohexasiloxane, Laureth-12, Caprylhydroxamic Acid, Iron Oxides (Black, CI 77499), Sodium Hyaluronate, Ethylhexylglycerin, Tocopherol, Glycyrrhiza Glabra (Licorice) Root Extract, Iron Oxides (CI77499).

Section 51945-4 (51945-4)

image components

Section 53413-1 (53413-1)

888-859-1188

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Active Ingredient

Zinc Oxide 13.3%

Titanium Dioxide 2.3%

Section 59845-8 (59845-8)

Apply generously 15 minutes before sun exposure

Reapply every 2 hours

Use a water resistant sunscreen if swimming or sweating

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 10am - 2pm,
  • Wear long-sleeved shirts, pants, hats, and sunglasses

Children under 6 months of age: Ask a doctor

Section 60561-8 (60561-8)

Store at 20-25C (68-77F)

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


Advanced Ingredient Data


Raw Label Data

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