Sun Bum 50 Mineral Sunscreen

Sun Bum 50 Mineral Sunscreen
SPL v2
SPL
SPL Set ID 3a263b85-e7a0-c068-e063-6294a90a49f2
Route
TOPICAL
Published
Effective Date 2025-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (160 mg) Titanium Dioxide (34 mg)
Inactive Ingredients
Polyhydroxystearic Acid (2300 Mw) Helianthus Annuus (sunflower) Seed Oil Sodium Stearoyl Glutamate Microcrystalline Cellulose Alumina Dicaprylyl Carbonate Cellulose Gum Propanediol Isocetyl Stearoyl Stearate Methyl Dihydroabietate Caprylyl Glycol Glycerin Coco-glucoside Silica Dimethyl Silylate Butyloctyl Salicylate Citric Acid Water Bisabolol Caprylhydroxamic Acid Polyester-8 (1400 Mw, Cyanodiphenylpropenoyl Capped) Banana Peel Sodium Gluconate Aloe Barbadensis Leaf Juice Tocopherol Bentonite Cetearyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-01

Description

Titainium dioxide 3.4%, zinc oxide 16%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titainium dioxide 3.4%, zinc oxide 16%

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

Flammable: do not use near hear, flame, or while smoking

Do not use on damaged or broken skin

When using this product

• keep out of eyes. Rinse with water to remove.

• use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

• do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F.

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 immediately.

Directions

• shake well before use

• hold container 4 to 6 inches from the skin to apply

• spray liberally and spread evenly by hand 15 minutes before sun exposure

• do not spray directly onto face. Spray on hands then apply to face.

• do not apply in windy conditions

• use in a well-ventilated area

•Avoid inhaling or exposing others to spray

• reapply: after 80 minutes of swimming or sweating

• immediately after towel drying

• at least every 2 hours

• children under 6 months of age: 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

Questions?

1-877-978-6286

Primary Artwork

Other Information

protect this product from excessive heat and direct sun

Active Ingredients

Titainium dioxide 3.4%, zinc oxide 16%

Inactive Ingredients

water, butyloctyl salicylate, dicaprylyl carbonate, helianthus annuus (sunflower) seed oil, propanediol, iscocetyl stearoyl stearate, methyl dihydroabieate, cetearyl alcohol, polyester-8, sodium stearoyl glutamate, coco-glucoside, aloe barbadensis leaf juice, musa sapientum (banana) fruit extract, tocopherol, glycerin, cellulose gum, bentonite, microcrystalline cellulose, caprylyl glycol, silica, polyhydroxystearic acid, citric acid, alumina, bisabolol, sodium gluconate, caprylhydroamic acid


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

Warnings

For external use only

Flammable: do not use near hear, flame, or while smoking

Do not use on damaged or broken skin

When using this product

• keep out of eyes. Rinse with water to remove.

• use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

• do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F.

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 immediately.

Directions

• shake well before use

• hold container 4 to 6 inches from the skin to apply

• spray liberally and spread evenly by hand 15 minutes before sun exposure

• do not spray directly onto face. Spray on hands then apply to face.

• do not apply in windy conditions

• use in a well-ventilated area

•Avoid inhaling or exposing others to spray

• reapply: after 80 minutes of swimming or sweating

• immediately after towel drying

• at least every 2 hours

• children under 6 months of age: 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

Questions?

1-877-978-6286

Primary Artwork

Other Information

protect this product from excessive heat and direct sun

Active Ingredients

Titainium dioxide 3.4%, zinc oxide 16%

Inactive Ingredients

water, butyloctyl salicylate, dicaprylyl carbonate, helianthus annuus (sunflower) seed oil, propanediol, iscocetyl stearoyl stearate, methyl dihydroabieate, cetearyl alcohol, polyester-8, sodium stearoyl glutamate, coco-glucoside, aloe barbadensis leaf juice, musa sapientum (banana) fruit extract, tocopherol, glycerin, cellulose gum, bentonite, microcrystalline cellulose, caprylyl glycol, silica, polyhydroxystearic acid, citric acid, alumina, bisabolol, sodium gluconate, caprylhydroamic acid


Advanced Ingredient Data


Raw Label Data

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