Eb-5 Super Hydrating Anti-aging Spf-50

Eb-5 Super Hydrating Anti-aging Spf-50
SPL v3
SPL
SPL Set ID b9521112-d119-4d48-8504-4e46b434f76f
Route
TOPICAL
Published
Effective Date 2024-01-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (100 mg) Zinc Cation (80 mg) Octisalate (50 mg)
Inactive Ingredients
Acetyl Hexapeptide-8 Amide Aloe Vera Leaf Water Ascorbic Acid Butylene Glycol C13-16 Isoparaffin Calendula Officinalis Flower Green Tea Leaf Medium-chain Triglycerides Caprylyl Glycol Carbomer Homopolymer, Unspecified Type Cetostearyl Alcohol Chamomile Citric Acid Monohydrate Coconut Carrot Dodecane Ethylhexylglycerin Ethyl Vanillin Glycerin Glyceryl Monostearate Helianthus Annuus Flowering Top Heptyl Undecylenate Hyaluronic Acid Magnesium Aluminum Silicate Palmitoyl Tetrapeptide-7 Palmitoyl Tripeptide-1 Avocado Oil Phenoxyethanol Polysorbate 20 Vitamin A Palmitate Saccharide Isomerate Sodium Citrate, Unspecified Form Sorbitan Monostearate .alpha.-tocopherol Acetate Tridecyl Salicylate Xanthan Gum Corn

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-12-26

Description

Octocrylene 10.00% Zinc Oxide 8.00% Octisalate 5.00%  

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Octocrylene 10.00% Zinc Oxide 8.00% Octisalate 5.00%  

Uses:
  • Helps prevent sunburn
  • Higher SPF gives more sunburn protection
  • If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early aging caused by the sun 
Warnings

For external use only.

Do Not Use

on damaged or broken skin.

Drug Facts

Directions:
  • Apply liberally all over the face, neck and chest 15 minutes before sun exposure. To maintain original protection, reapply every 2 hours. Use every morning as the last step in your daily skincare regime. Can be used alone or under make-up. Can also be used on full body.
  • Children under 6 months of age: ask a doctor.
  • Use a water -resistant sunscreen if swimming or sweating

Sun Protection Measures

Sp ending 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:

  • Limit time in the sun, especially from 10 a.m.-2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses.
Package Labeling:

Active Ingredients

Octocrylene 10.00%

Zinc Oxide 8.00%

Octisalate 5.00%  

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

Acetyl Hexapeptide-8, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Argania Spinosa (Argan) Oil, Ascorbic Acid (Vitamin C), Butylene Glycol, Butyrispermum Parkii (Shea) Butter, C13-16 Isoalkane, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglycerin, Caprylyl Glycol, Carbomer, Cetearyl Alcohol, Chamomilla Matricaria (Chamomile) Extract, Citric Acid, Coco Nucifera (Coconut) Oil, Daucus Carota Sativa (Carrot) Extract, Dodecane, Ethylhexlyglycerin, Ethyl Vanillin, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunfloer) Oil, Heptyl Undecylenate, Hyaluronic Acid, Magnesium Aluminum Silicate, Palmitoyl Tetrapeptide-7, Palmitoyl Tripeptide-1, Persea Gratissima (Avocado) Oil, Phenoxyethanol, Polyhydroxystearic Acid, Polysorbate 20, Retinyl Palmitate (Vitamin A), Saccharide Isomerate, Sodium citrate, Sorbitan Stearate, Tocopheryl Acetate (Vitamin E), Tridecyl Salicylate, Xanthan Gum, Zemea (Corn) Propanediol.

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.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding, ask a health professional before use


Structured Label Content

Uses:
  • Helps prevent sunburn
  • Higher SPF gives more sunburn protection
  • If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early aging caused by the sun 
Purpose

Sunscreen

Warnings

For external use only.

Do Not Use (Do not use)

on damaged or broken skin.

Drug Facts

Directions:
  • Apply liberally all over the face, neck and chest 15 minutes before sun exposure. To maintain original protection, reapply every 2 hours. Use every morning as the last step in your daily skincare regime. Can be used alone or under make-up. Can also be used on full body.
  • Children under 6 months of age: ask a doctor.
  • Use a water -resistant sunscreen if swimming or sweating

Sun Protection Measures

Sp ending 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:

  • Limit time in the sun, especially from 10 a.m.-2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses.
Package Labeling:

Active Ingredients

Octocrylene 10.00%

Zinc Oxide 8.00%

Octisalate 5.00%  

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

Acetyl Hexapeptide-8, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Argania Spinosa (Argan) Oil, Ascorbic Acid (Vitamin C), Butylene Glycol, Butyrispermum Parkii (Shea) Butter, C13-16 Isoalkane, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglycerin, Caprylyl Glycol, Carbomer, Cetearyl Alcohol, Chamomilla Matricaria (Chamomile) Extract, Citric Acid, Coco Nucifera (Coconut) Oil, Daucus Carota Sativa (Carrot) Extract, Dodecane, Ethylhexlyglycerin, Ethyl Vanillin, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunfloer) Oil, Heptyl Undecylenate, Hyaluronic Acid, Magnesium Aluminum Silicate, Palmitoyl Tetrapeptide-7, Palmitoyl Tripeptide-1, Persea Gratissima (Avocado) Oil, Phenoxyethanol, Polyhydroxystearic Acid, Polysorbate 20, Retinyl Palmitate (Vitamin A), Saccharide Isomerate, Sodium citrate, Sorbitan Stearate, Tocopheryl Acetate (Vitamin E), Tridecyl Salicylate, Xanthan Gum, Zemea (Corn) Propanediol.

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 or irritation develops and lasts.

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. If pregnant or breast-feeding, ask a health professional before use


Advanced Ingredient Data


Raw Label Data

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