Mineral Sunscreen Lotion + Antioxidants Spf50

Mineral Sunscreen Lotion + Antioxidants Spf50
SPL v2
SPL
SPL Set ID 34bb8560-8223-e810-e063-6394a90ad45d
Route
TOPICAL
Published
Effective Date 2025-05-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (100 mg) Titanium Dioxide (80 mg)
Inactive Ingredients
Propanediol Sodium Benzoate Cetyl Peg/ppg-10/1 Dimethicone (hlb 5) Dimethicone 100 Aluminum Stearate C12-15 Alkyl Benzoate Caprylyl Glycol Ethylhexyl Palmitate Octyldodecyl Neopentanoate Triethoxycaprylylsilane Potassium Sorbate Hydroxyacetophenone Edetate Disodium Hexyl Laurate Polyglyceryl-4 Isostearate Polyhydroxystearic Acid (2300 Mw) Water Methyl Glucose Dioleate Glycerin Tocopherol Ethylhexyl Stearate .alpha.-tocopherol Acetate, D- Alumina Vp/hexadecene Copolymer Euphorbia Cerifera (candelilla) Wax Peg-7 Hydrogenated Castor Oil Trimethylsiloxysilicate (m/q 0.8-1.0) Aphanizomenon Flosaquae Butyloctyl Salicylate Cetyl Dimethicone 25 1,2-hexanediol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-09

Description

Protect this product from excessive heat and direct sun Avoid long-term exposure storage above 40°C (104°F) May stain some fabrics

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Protect this product from excessive heat and direct sun Avoid long-term exposure storage above 40°C (104°F) May stain some fabrics

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

Directions

Shake well before use

Apply liberally and spread evenly by hand 15 minutes before sun exposure

Reapply:

after 80 minutes of swimming or sweating immediately after towel use

at least every 2 hours

Sun Protection Measures

Spending time in the sun can increase your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

Limiting time in the sun, especially from 10a.m. - 2p.m.

Wearing long-sleeved shirts, pants, hats and sunglasses

Children under six months: Ask a doctor

Questions?
Sunscreen Label

Other Information

Protect this product from excessive heat and direct sun

Avoid long-term exposure storage above 40°C (104°F)

May stain some fabrics

Active Ingredients

Titanium Dioxide 8%

Zinc Oxide 10%

Inactive Ingredients

1,2-Hexanediol, Alumina, Aluminum Stearate, Aphanizomenon Flos-aquae Extract, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Caprylyl Glycol, Cetyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Dimethicone, Disodium EDTA, Ethylhexyl Palmitate, Ethylhexyl Stearate, Euphorbia Cerifera (Candelilla) Wax, Glycerin, Hexyl Laurate, Hydroxyacetophenone, Methyl Glucose Dioleate, Octyldodecyl Neopentanoate, PEG-7 Hydrogenated Castor Oil, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Potassium Sorbate, Propanediol, Sodium Benzoate, Tocopherol (Vitamin E), Tocopheryl Acetate, Triethoxycaprylylsilane, Trimethylsiloxysilicate, VP/Hexadecene Copolymer, Water.


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

Sunscreen

Directions

Shake well before use

Apply liberally and spread evenly by hand 15 minutes before sun exposure

Reapply:

after 80 minutes of swimming or sweating immediately after towel use

at least every 2 hours

Sun Protection Measures

Spending time in the sun can increase your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

Limiting time in the sun, especially from 10a.m. - 2p.m.

Wearing long-sleeved shirts, pants, hats and sunglasses

Children under six months: Ask a doctor

Questions?
Sunscreen Label

Other Information

Protect this product from excessive heat and direct sun

Avoid long-term exposure storage above 40°C (104°F)

May stain some fabrics

Active Ingredients

Titanium Dioxide 8%

Zinc Oxide 10%

Inactive Ingredients

1,2-Hexanediol, Alumina, Aluminum Stearate, Aphanizomenon Flos-aquae Extract, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Caprylyl Glycol, Cetyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Dimethicone, Disodium EDTA, Ethylhexyl Palmitate, Ethylhexyl Stearate, Euphorbia Cerifera (Candelilla) Wax, Glycerin, Hexyl Laurate, Hydroxyacetophenone, Methyl Glucose Dioleate, Octyldodecyl Neopentanoate, PEG-7 Hydrogenated Castor Oil, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Potassium Sorbate, Propanediol, Sodium Benzoate, Tocopherol (Vitamin E), Tocopheryl Acetate, Triethoxycaprylylsilane, Trimethylsiloxysilicate, VP/Hexadecene Copolymer, Water.


Advanced Ingredient Data


Raw Label Data

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