Skin Proud Serious Shade Sunscreen Spf 50
FDA Label NDC 82803-001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Lottie London Limited for the product Skin Proud Serious Shade Sunscreen Spf 50 (NDC 82803-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a physician, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredients

→ Purpose

→ Uses

→ Warnings

→ Do Not Use

→ When Using This Product

→ Stop Use And Ask A Physician

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Company Information

→ Product Packaging

Active Ingredients

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 10%

Purpose

Sunscreen

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.

Do Not Use

on damaged or broken skin.

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.

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

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.

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.