Sun Bum Mineral Sunscreen Spray Spf 50

Sun Bum Mineral Sunscreen Spray Spf 50
SPL v3
SPL
SPL Set ID c239fce6-b880-f988-e053-2995a90a3903
Route
TOPICAL
Published
Effective Date 2021-05-13
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 Sunflower Oil Dicaprylyl Carbonate Propanediol Isocetyl Stearoyl Stearate Methyl Dihydroabietate Cetostearyl Alcohol Polyester-8 (1400 Mw, Cyanodiphenylpropenoyl Capped) Sodium Stearoyl Glutamate Coco Glucoside Aloe Vera Leaf Banana Tocopherol Glycerin Carboxymethylcellulose Sodium, Unspecified Bentonite Microcrystalline Cellulose Caprylyl Glycol Silicon Dioxide Polyhydroxystearic Acid (2300 Mw) Citric Acid Monohydrate Aluminum Oxide Levomenol Sodium Gluconate Caprylhydroxamic Acid

Identifiers & Packaging

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

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.
  • 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 into face. spray on hands then apply to face 
  • do not apply in windy conditions 
  • use in well-ventilated area 
  • Reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours •children under 6 months: 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, helianthus annuus (sunflower) seed oil, dicaprylyl carbonate, propanediol, isocetyl stearoyl stearate, methyl dihydroabietate, 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, caprylhydroxamic acid

When Using This Product
  • keep out of eyes. Rinse with water to remove.
  • use only as directed. Interntional misuse by delibarately 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.


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.
  • 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 into face. spray on hands then apply to face 
  • do not apply in windy conditions 
  • use in well-ventilated area 
  • Reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours •children under 6 months: 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, helianthus annuus (sunflower) seed oil, dicaprylyl carbonate, propanediol, isocetyl stearoyl stearate, methyl dihydroabietate, 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, caprylhydroxamic acid

When Using This Product (When using this product)
  • keep out of eyes. Rinse with water to remove.
  • use only as directed. Interntional misuse by delibarately 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 (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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