Baby Bum Mineral 50 Sunscreen

Baby Bum Mineral 50 Sunscreen
SPL v1
SPL
SPL Set ID 3c470ff8-37d6-a729-e063-6294a90aa525
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
Sodium Gluconate Tocopherol Silica Bentonite Aloe Barbadensis Leaf Juice Polyhydroxystearic Acid (2300 Mw) Polyester-8 (1400 Mw, Cyanodiphenylpropenoyl Capped) Isocetyl Stearoyl Stearate Methyl Dihydroabietate Caprylhydroxamic Acid Bisabolol C18-21 Alkane Citric Acid Microcrystalline Cellulose Alumina Cetearyl Alcohol Butyloctyl Salicylate Dicaprylyl Carbonate Sodium Stearoyl Glutamate Banana Water Isononyl Isononanoate Coco-glucoside Propanediol Cellulose Gum Caprylyl Glycol Glycerin

Identifiers & Packaging

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

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

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

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

Directions

• shake well before use

• 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.

• 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

Other Information

protect this product from excessive heat and direct sun

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

Baby Bum Mineral 50 Sunscreen Primary Artwork

Baby Bum Mineral 50 Sunscreen Roll On Primary Artwork


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

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

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

Directions

• shake well before use

• 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.

• 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

Other Information

protect this product from excessive heat and direct sun

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

Baby Bum Mineral 50 Sunscreen Primary Artwork

Baby Bum Mineral 50 Sunscreen Roll On Primary Artwork (Baby Bum Mineral 50 Sunscreen Roll-On Primary Artwork)


Advanced Ingredient Data


Raw Label Data

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