Sun Bum Mineral Sunscreen Roll On Lotion Spf 50

Sun Bum Mineral Sunscreen Roll On Lotion Spf 50
SPL v2
SPL
SPL Set ID 81e06c01-26ee-425f-9b77-f189563f9127
Route
TOPICAL
Published
Effective Date 2021-08-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (34 mg) Zinc Cation (160 mg)
Inactive Ingredients
Water Butyloctyl Salicylate Dicaprylyl Carbonate Isononyl Isononanoate Propanediol Isocetyl Stearoyl Stearate Methyl Dihydroabietate Cetostearyl Alcohol Aloe Vera Leaf Banana Levomenol Bentonite Carboxymethylcellulose Sodium, Unspecified C18-c21 Alkane Caprylyl Glycol Citric Acid Monohydrate Coco Glucoside Glycerin Microcrystalline Cellulose Sodium Gluconate Sodium Stearoyl Glutamate Tocopherol Polyester-8 (1400 Mw, Cyanodiphenylpropenoyl Capped) Silicon Dioxide Aluminum Oxide Caprylhydroxamic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2022-01-01

Description

Titanium dioxide 3.4%, Zinc oxide 16%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium 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

Directions

• shake well before use • apply liberally and spread by hand15 minutes before sun exposure • 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

Do Not Use

on damaged or broken skin

Drug Facts

Questions?

1-877-978-6286

Other Information

protect this product from excessive heat and direct sun

Package Labeling:

Active Ingredients

Titanium dioxide 3.4%, Zinc oxide 16%

Inactive Ingredients

water, butyloctyl salicylate, dicaprylyl carbonate, isononyl isononanoate, propanediol, isocetyl stearoyl stearate, methyl dihydroabietate, cetearyl alcohol, aloe barbadensis leaf juice, musa sapientum (banana) fruit extract, bisabolol, bentonite, cellulose gum, C18-21 alkane, caprylyl glycol, citric acid, coco-glucoside, glycerin, microcrystalline cellulose, polyhydroxystearic acid, sodium gluconate, sodium stearoyl glutamate, tocopherol, polyester-8, silica, alumina, caprylhydroxamic acid

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 immediately.


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

Directions

• shake well before use • apply liberally and spread by hand15 minutes before sun exposure • 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

Do Not Use (Do not use)

on damaged or broken skin

Drug Facts

Questions?

1-877-978-6286

Other Information (Other information)

protect this product from excessive heat and direct sun

Package Labeling:

Active Ingredients (Active ingredients)

Titanium dioxide 3.4%, Zinc oxide 16%

Inactive Ingredients (Inactive ingredients)

water, butyloctyl salicylate, dicaprylyl carbonate, isononyl isononanoate, propanediol, isocetyl stearoyl stearate, methyl dihydroabietate, cetearyl alcohol, aloe barbadensis leaf juice, musa sapientum (banana) fruit extract, bisabolol, bentonite, cellulose gum, C18-21 alkane, caprylyl glycol, citric acid, coco-glucoside, glycerin, microcrystalline cellulose, polyhydroxystearic acid, sodium gluconate, sodium stearoyl glutamate, tocopherol, polyester-8, silica, alumina, caprylhydroxamic acid

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 immediately.


Advanced Ingredient Data


Raw Label Data

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