Baby Bum Spf50 Mineral Sunscreen Lotion

Baby Bum Spf50 Mineral Sunscreen Lotion
SPL v6
SPL
SPL Set ID 606d2aea-26c1-44a1-8452-02663b3e51dd
Route
TOPICAL
Published
Effective Date 2021-06-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (200 mg)
Inactive Ingredients
Water Coconut Oil Butyloctyl Salicylate Diheptyl Succinate Methyl Dihydroabietate Shea Butter Capryloyl Glycerin/sebacic Acid Copolymer (2000 Mpa.s) Sodium Stearoyl Glutamate Cetostearyl Alcohol Cocoa Butter Hyaluronate Sodium Levomenol Tocopherol Coco Glucoside Microcrystalline Cellulose Carboxymethylcellulose Sodium, Unspecified Form Cetyl Alcohol Arachidyl Alcohol Docosanol Arachidyl Glucoside Sodium Gluconate Phenoxyethanol Ethylhexylglycerin Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-10-11
Description

Zinc oxide 20%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Zinc oxide 20%

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
  • apply liberally 15 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 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-sleeve shirts, pants, hats, and sunglasses.
Questions?

call 1 877-978-6286

Do Not Use 

on damaged or broken skin.

Other Information
  • protect this product from excessive heat and direct sun.
  • keep outer card for complete directions and warnings
Package Labeling:

Active Ingredients

Zinc oxide 20%

Inactive Ingredients

water, cocos nucifera (coconut) oil, butyloctyl salicylate, diheptyl succinate, methyl dihydroabietate, butyrospermum parkii (shea butter), capryloyl glycerin/sebacic acid copolymer, sodium stearoyl glutamate, cetearyl alcohol, theobroma cacao (cocoa) seed butter, sodium hyaluronate, bisabolol, tocopherol, coco-glucoside, microcrystalline cellulose, cellulose gum, cetyl alcohol, arachidyl alcohol, behenyl alcohol, arachidyl glucoside, polyhydroxystearic acid, sodium gluconate, phenoxyethanol, ethylhexylglycerin, citric acid

When Using This Product:

Keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor

if rash occurs.

Package Labeling:69039 255 01

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
  • apply liberally 15 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 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-sleeve shirts, pants, hats, and sunglasses.
Questions?

call 1 877-978-6286

Do Not Use  (Do not use )

on damaged or broken skin.

Other Information
  • protect this product from excessive heat and direct sun.
  • keep outer card for complete directions and warnings
Package Labeling:

Active Ingredients

Zinc oxide 20%

Inactive Ingredients (Inactive ingredients)

water, cocos nucifera (coconut) oil, butyloctyl salicylate, diheptyl succinate, methyl dihydroabietate, butyrospermum parkii (shea butter), capryloyl glycerin/sebacic acid copolymer, sodium stearoyl glutamate, cetearyl alcohol, theobroma cacao (cocoa) seed butter, sodium hyaluronate, bisabolol, tocopherol, coco-glucoside, microcrystalline cellulose, cellulose gum, cetyl alcohol, arachidyl alcohol, behenyl alcohol, arachidyl glucoside, polyhydroxystearic acid, sodium gluconate, phenoxyethanol, ethylhexylglycerin, citric acid

When Using This Product: (When using this product:)

Keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if rash occurs.

Package Labeling:69039 255 01 (Package Labeling:69039-255-01)

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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:05.380834 · Updated: 2026-03-14T23:00:23.363901