Skin Proud Serious Shade Sunscreen Spf 50

Skin Proud Serious Shade Sunscreen Spf 50
SPL v1
SPL
SPL Set ID ebf2f7f8-1a13-1986-e053-2995a90a3982
Route
TOPICAL
Published
Effective Date 2022-10-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (150 mg) Octisalate (50 mg) Octocrylene (100 mg)
Inactive Ingredients
Water Silicon Dioxide Cetyl Dimethicone 25 Peg-15 Cocamine Peg-40 Stearate Caprylyl Glycol Aloe Vera Leaf Ceramide Np Sodium Hydroxide Geraniol Citral Carbomer Copolymer Type B (allyl Pentaerythritol Crosslinked) Limonene, (+)- .alpha.-hexylcinnamaldehyde Linalool, (+)- Stearyl Behenate Alkyl (c12-15) Benzoate Caprylhydroxamic Acid Malpighia Glabra Fruit Glycerin Polyhydroxystearic Acid (2300 Mw) Phenoxyethanol .alpha.-tocopherol Acetate Cetostearyl Alcohol Coco-glycerides Edetate Disodium Anhydrous Spirulina Platensis

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2023-02-27

Description

Avobenzone 3% Homosalate 15% Octisalate 5% Octocrylene 10%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 15% Octisalate 5% Octocrylene 10%

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
  • Apply generously and evenly 15 minutes before sun exposure.
  • Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating.
  • 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.
  • For use on children under 6 months of age: Ask a doctor
Do Not Use

on damaged or broken skin.

Other Information
  • Protect this product from excessive heat and direct sun.
  • You may report a serious adverse reaction to this product to Report Reaction, LLC, PO Box 22, Plainsboro, NJ 08536.
Product Packaging

Active Ingredients

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 10%

Company Information

Made in Australia

Dist. by: Lottie London Limited, Batchworth House, Herts, WD3 1JE, UK Oxford Eireann, North Point House, Cork, T23AT2P, Ireland

www.iamproud.com

Inactive Ingredients

Aqua (Water, Eau), Cocoglycerides, Silica, Cetyl Dimethicone, Peg-15 Cocamine, Stearyl Behenate, Glycerin, C12-15 Alkyl Benzoate, Peg-40 Stearate, Polyhydroxystearic Acid, Phenoxyethanol, Tocopheryl Acetate, Caprylyl Glycol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Parfum (Fragrance), Disodium Edta, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Caprylhydroxamic Acid, Malpighia Punicifolia Fruit Extract, Spirulina Platensis Powder, Aloe Barbadensis Leaf Juice, Cetearyl Alcohol, Sodium Hydroxide, Ceramide Np, Limonene, Hexyl Cinnamal, Linalool, Geraniol, Citral.

When Using This Product

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Physician

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

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
  • Apply generously and evenly 15 minutes before sun exposure.
  • Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating.
  • 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.
  • For use on children under 6 months of age: Ask a doctor
Do Not Use (Do not use)

on damaged or broken skin.

Other Information (Other information)
  • Protect this product from excessive heat and direct sun.
  • You may report a serious adverse reaction to this product to Report Reaction, LLC, PO Box 22, Plainsboro, NJ 08536.
Product Packaging

Active Ingredients (Active ingredients)

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 10%

Company Information

Made in Australia

Dist. by: Lottie London Limited, Batchworth House, Herts, WD3 1JE, UK Oxford Eireann, North Point House, Cork, T23AT2P, Ireland

www.iamproud.com

Inactive Ingredients (Inactive ingredients)

Aqua (Water, Eau), Cocoglycerides, Silica, Cetyl Dimethicone, Peg-15 Cocamine, Stearyl Behenate, Glycerin, C12-15 Alkyl Benzoate, Peg-40 Stearate, Polyhydroxystearic Acid, Phenoxyethanol, Tocopheryl Acetate, Caprylyl Glycol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Parfum (Fragrance), Disodium Edta, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Caprylhydroxamic Acid, Malpighia Punicifolia Fruit Extract, Spirulina Platensis Powder, Aloe Barbadensis Leaf Juice, Cetearyl Alcohol, Sodium Hydroxide, Ceramide Np, Limonene, Hexyl Cinnamal, Linalool, Geraniol, Citral.

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Physician (Stop use and ask a physician)

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.


Advanced Ingredient Data


Raw Label Data

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