miami beach bum spf-50 blocked sunscreen

miami beach bum spf-50 blocked sunscreen
SPL v1
SPL
SPL Set ID 2cf40d87-626b-4309-8f13-fd980161c62f
Route
topical
Published
Effective Date 2024-02-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc cation (150 mg)
Inactive Ingredients
adansonia digitata seed oil allantoin aloe vera leaf water broccoli butyloctyl salicylate c13-16 isoparaffin green tea leaf medium-chain triglycerides safflower citric acid monohydrate watermelon decyl glucoside dodecane glycerin glyceryl monostearate glyceryl stearate citrate leuconostoc/radish root ferment filtrate niacinamide avocado oil sorbitan monostearate .alpha.-tocopherol acetate tridecyl salicylate triheptanoin xanthan gum corn

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-02-19

Purpose

Sunscreen

Description

Zinc Oxide 15%


Medication Information

Warnings

For external use only

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

Directions
  • Apply liberally 15 minutes before sun exposure 
  • Reapply:
  • after 80 minutes of swimming or sweating 
  • immidiately after towel drying
  • at least every 2 hours
  • S un 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 sunglasess
  • Children under 6 months: Ask a doctor
Other Information
  • Protect this product from excessive heat and direct sun.
Inactive Ingredients

Adansonia Digitata (Baobab) Oil, Algae Extract, Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Brassica Oleracea (Broccoli) Extract, Butyloctyl Salicylate, C13-16 Isoalkane, Camellia Sinensis (Green tea) Etract, Caprylic/Capric Triglyceride, Carthamus  Tinctorious (safflower) oil, Citric Acid, Citrullus Lanatus (Watermelon) Extract, Decyl Glucoside, Dodecane, Glycerin, Glyceryl Stearate, Glyceryl Stearate Citrate, Leuconostoc/Radish Root Ferment Filtrate, Niacinamide, Persea Gratissima (Avocado) Oil, Polyhydroxystearic Acid, Sorbitan Stearate, Tocopheryl Acetate (Vitamin E), Tridecyl Salicylate, Triheptanoin, Xanthan Gum, Zemea (Corn) Propanediol.

Description

Zinc Oxide 15%

Questions?

305-399-7580

Do Not Use

on damaged or broken skin

Drug Facts

Active Ingredient

Zinc Oxide 15%

Package Labeling:

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 product is swallowed, get medical help or contact a Poison Control Centre right away.


Structured Label Content

Warnings

For external use only

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

Directions
  • Apply liberally 15 minutes before sun exposure 
  • Reapply:
  • after 80 minutes of swimming or sweating 
  • immidiately after towel drying
  • at least every 2 hours
  • S un 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 sunglasess
  • Children under 6 months: Ask a doctor
Other Information
  • Protect this product from excessive heat and direct sun.
Inactive Ingredients

Adansonia Digitata (Baobab) Oil, Algae Extract, Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Brassica Oleracea (Broccoli) Extract, Butyloctyl Salicylate, C13-16 Isoalkane, Camellia Sinensis (Green tea) Etract, Caprylic/Capric Triglyceride, Carthamus  Tinctorious (safflower) oil, Citric Acid, Citrullus Lanatus (Watermelon) Extract, Decyl Glucoside, Dodecane, Glycerin, Glyceryl Stearate, Glyceryl Stearate Citrate, Leuconostoc/Radish Root Ferment Filtrate, Niacinamide, Persea Gratissima (Avocado) Oil, Polyhydroxystearic Acid, Sorbitan Stearate, Tocopheryl Acetate (Vitamin E), Tridecyl Salicylate, Triheptanoin, Xanthan Gum, Zemea (Corn) Propanediol.

Questions?

305-399-7580

Do Not Use (Do not use)

on damaged or broken skin

Drug Facts

Active Ingredient

Zinc Oxide 15%

Package Labeling:

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

Keep Out of Reach of Children. (Keep out of reach of children.)

If product is swallowed, get medical help or contact a Poison Control Centre right away.


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Raw Label Data

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