miami md sun shield broad spectrum spf 40

miami md sun shield broad spectrum spf 40
SPL v2
SPL
SPL Set ID 3a53d53a-129a-41c3-a8e7-c1b1bb98d8bd
Route
topical
Published
Effective Date 2022-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (30 mg) homosalate (90 mg) octisalate (50 mg) octocrylene (60 mg)
Inactive Ingredients
water aloe vera leaf medium-chain triglycerides corn polysorbate 20 cetostearyl alcohol cetearyl glucoside cyclomethicone 5 phenoxyethanol ethylhexylglycerin ascorbyl palmitate banana coconut oil hyaluronate sodium glycyrrhiza glabra alkyl (c12-15) benzoate tetrahexyldecyl ascorbate kiwi fruit niacinamide citric acid monohydrate glycerin jasminum officinale flower .alpha.-tocopherol acetate magnesium aluminum silicate astaxanthin

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2022-12-05

Purpose

Sunscreen

Description

Avobenzone 3.00% Homosalate 9.00% Octisalate 5.00% Octocrylene 6.00%


Medication Information

Warnings

For external use only

Purpose

Sunscreen

Directions
  • Apply liberally 15 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.
  • Reapply at least every 2 hours.
  • Use a water resistant sunscreen if swimming or sweating.
  • Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including: Sun Protection Measures. 
  • Limit time in the sunm especially from 10 a.m. - 2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses.
Description

Avobenzone 3.00% Homosalate 9.00% Octisalate 5.00% Octocrylene 6.00%

Questions?

1-844-829-8772

Uses:
  • Helps prevent sunburn.
  • Higher SPF gives more sunburn protection.
  • If used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions
Do Not Use 
  • on damaged or broken skin.
Package Labeling:

Active Ingredients

Avobenzone 3.00% Homosalate 9.00% Octisalate 5.00% Octocrylene 6.00%





Other Information:
  • Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients:

Aqua (Deionized Water), Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Glyceryl Stearate Citrate, Caprylic/Capric Triglyceride, Zemea (Corn) Propanediol, Polysorbate-20, Cetearyl Alcohol, Cetearyl Glucoside, Cyclopentasiloxane, Bis-Vinyl Dimethicone/Dimethicone Copolymer, Phenoxyethanol, Ethylhexylglycerin, Ascorbyl Palmitate (Vitamin C), Rosa Damascena (Rose) Extract, Musa Sapientum (Banana) Extract, Cocos Nucifera (Coconut) Oil, Sodium Hyaluronate, Glycyrrhiza Glabra (Licorice) Extract, C12-15 Alkyl Benzoate, Tetrahexyldecyl Ascorbate (Vitamin C), Actinidia Chinensis (Kiwi) Extract, Niacinamide, Citric Acid, Glycerin, Jasminum Officinale (Jasmine) Extract, Tocopheryl Acetate (Vitamin E), Magnesium Aluminum Silicate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Astaxanthin.

When Using This Product

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If

rash or irritation develops and lasts.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children. 

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Warnings

For external use only

Purpose

Sunscreen

Directions
  • Apply liberally 15 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.
  • Reapply at least every 2 hours.
  • Use a water resistant sunscreen if swimming or sweating.
  • Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including: Sun Protection Measures. 
  • Limit time in the sunm especially from 10 a.m. - 2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses.
Questions?

1-844-829-8772

Uses:
  • Helps prevent sunburn.
  • Higher SPF gives more sunburn protection.
  • If used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions
Do Not Use  (Do not use )
  • on damaged or broken skin.
Package Labeling:

Active Ingredients

Avobenzone 3.00% Homosalate 9.00% Octisalate 5.00% Octocrylene 6.00%





Other Information:
  • Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients:

Aqua (Deionized Water), Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Glyceryl Stearate Citrate, Caprylic/Capric Triglyceride, Zemea (Corn) Propanediol, Polysorbate-20, Cetearyl Alcohol, Cetearyl Glucoside, Cyclopentasiloxane, Bis-Vinyl Dimethicone/Dimethicone Copolymer, Phenoxyethanol, Ethylhexylglycerin, Ascorbyl Palmitate (Vitamin C), Rosa Damascena (Rose) Extract, Musa Sapientum (Banana) Extract, Cocos Nucifera (Coconut) Oil, Sodium Hyaluronate, Glycyrrhiza Glabra (Licorice) Extract, C12-15 Alkyl Benzoate, Tetrahexyldecyl Ascorbate (Vitamin C), Actinidia Chinensis (Kiwi) Extract, Niacinamide, Citric Acid, Glycerin, Jasminum Officinale (Jasmine) Extract, Tocopheryl Acetate (Vitamin E), Magnesium Aluminum Silicate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Astaxanthin.

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 or irritation develops and lasts.

If Pregnant Or Breast Feeding, (If pregnant or breast feeding,)

ask a health professional before use.

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

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)