Physical Sunscreen Spf50 80 Min Wr 159-100

Physical Sunscreen Spf50 80 Min Wr 159-100
SPL v2
SPL
SPL Set ID 0cca7b65-e24a-429c-b157-5f4e343424ab
Route
TOPICAL
Published
Effective Date 2023-11-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (42.3 g) Zinc Cation (182.8 g)
Inactive Ingredients
Water C15-19 Alkane Octyldodecyl Neopentanoate Butyloctyl Salicylate Dimethicone Polyglyceryl-4 Diisostearate/polyhydroxystearate/sebacate Glycerin Polyhydroxystearic Acid (2300 Mw) Sodium Chloride Triethoxycaprylylsilane Saccharide Isomerate Hydroxyacetophenone Niacinamide Sorbitan Olivate 1,2-hexanediol Caprylyl Glycol Edetate Disodium Pentylene Glycol Gellan Gum (low Acyl) Polygonum Aviculare Whole Anhydrous Citric Acid Sodium Citrate Potassium Sorbate Sodium Benzoate Medium-chain Triglycerides Hydrogenated Polybutene (1300 Mw) Silicon Dioxide Glyceryl Monobehenate .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-11-09

Description

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 physician if rash occurs. If product is swallowed get medical help or contact a Poison Control Center right away.


Medication Information

Description

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 physician if rash occurs. If product is swallowed get medical help or contact a Poison Control Center right away.

Uses

Helps prevent sunburn. If used as directed with other sun protection measure (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Labeling

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 physician if rash occurs. If product is swallowed get medical help or contact a Poison Control Center right away.

Questions

Call toll free 1-866-416-2366

Directions

Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating, immediately after towel drying and 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 of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 am to 2 pm. Wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months: ask a physician.

Other Information

Protect this product from excessive heat and direct sun.

Active Ingredients

Titanium Dioxide 4.23% Sunscreen

Zinc Oxide 18.28% Sunscreen

Inactive Ingredients

Water, C15-19 Alkane, Octyldodecyl Neopentanoate, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Dimethicone, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Glycerin, Hydrogenated Polyisobutene, Polyhydroxystearic Acid, Sodium Chloride, Triethoxycaprylylsilane, Silica, Saccharide Isomerate, Hydroxyacetophenone, Niacinamide, Sorbitan Olivate, Glyceryl Behenate, 1,2-Hexanediol, Caprylyl Glycol, Tocopheryl Acetate, Disodium EDTA, Scenedesmus Rubescens Extract, Gellan Gum, Polygonum Aviculare Extract, citric acid, sodium citrate, potassium sorbate, sodium benzoate

Keep Out of Reach of Children

Keep out of reach of children


Structured Label Content

Uses

Helps prevent sunburn. If used as directed with other sun protection measure (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Labeling

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 physician if rash occurs. If product is swallowed get medical help or contact a Poison Control Center right away.

Questions

Call toll free 1-866-416-2366

Directions

Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating, immediately after towel drying and 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 of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 am to 2 pm. Wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months: ask a physician.

Other Information (Other information)

Protect this product from excessive heat and direct sun.

Active Ingredients

Titanium Dioxide 4.23% Sunscreen

Zinc Oxide 18.28% Sunscreen

Inactive Ingredients (Inactive ingredients)

Water, C15-19 Alkane, Octyldodecyl Neopentanoate, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Dimethicone, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Glycerin, Hydrogenated Polyisobutene, Polyhydroxystearic Acid, Sodium Chloride, Triethoxycaprylylsilane, Silica, Saccharide Isomerate, Hydroxyacetophenone, Niacinamide, Sorbitan Olivate, Glyceryl Behenate, 1,2-Hexanediol, Caprylyl Glycol, Tocopheryl Acetate, Disodium EDTA, Scenedesmus Rubescens Extract, Gellan Gum, Polygonum Aviculare Extract, citric acid, sodium citrate, potassium sorbate, sodium benzoate

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

Keep out of reach of children


Advanced Ingredient Data


Raw Label Data

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