Sun Bum Mineral Sunscreen Lotion Broad Spectrum Spf 50

Sun Bum Mineral Sunscreen Lotion Broad Spectrum Spf 50
SPL v3
SPL
SPL Set ID bcd0d483-f506-4c7c-e053-2995a90a5733
Route
TOPICAL
Published
Effective Date 2021-09-18
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 Arachidyl Alcohol Coco Glucoside Tocopherol Cocoa Butter Cetyl Alcohol Docosanol Levomenol Arachidyl Glucoside Microcrystalline Cellulose Carboxymethylcellulose Sodium, Unspecified Hyaluronate Sodium Sodium Gluconate Phenoxyethanol Citric Acid Monohydrate Ethylhexylglycerin Polyhydroxystearic Acid (2300 Mw)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-02-22

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
  • shake well before use
  • 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 Protections Measures- Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regurlarly 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 ingredient

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, arachidyl alcohol, coco glucoside, tocopherol, theobroma cacao (cocoa) seed butter, cetyl alcohol, behenyl alcohol, bisabolol, arachidyl glucoside, microcrystalline cellulose, cellulose gum, sodium hyaluronate, sodium gluconate, phenoxyethanol, citric acid, ethylhexylglycerin, polyhydroxystearic 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 623 02

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 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 Protections Measures- Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regurlarly 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 ingredient

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, arachidyl alcohol, coco glucoside, tocopherol, theobroma cacao (cocoa) seed butter, cetyl alcohol, behenyl alcohol, bisabolol, arachidyl glucoside, microcrystalline cellulose, cellulose gum, sodium hyaluronate, sodium gluconate, phenoxyethanol, citric acid, ethylhexylglycerin, polyhydroxystearic 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
Package Labeling:69039 623 02 (Package Labeling:69039-623-02)

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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