Otc - Active Ingredient
Active Ingredients Purpose
Avobenzone 3% sunscreen
Homosalate 15%
Octisalate 5%
Octocrylene 7%
Medik8 Advanced Day Uv Protect Sunscreen Broad Spectrum Spf 50 Cream
FDA Label NDC 79988-003
8 label sections · Submitted to the FDA by Medik8 Ltd · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Medik8 Ltd for the product Medik8 Advanced Day Uv Protect Sunscreen Broad Spectrum Spf 50 (NDC 79988-003). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
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
Otc - 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.
Indications & Usage
Stop use and ask a doctor if rash occurs.
Warnings
Warnings
For external use only
Flammable until dry. Do not use
- on damaged or broken skin
- keep out of eyes. Rinse with water to remove.
When using this product
Dosage & Administration
Directions: For Sunscreen Use
- apply liberally 15 minutes before sun exposure
- reapply every 2 hours
- use a water resistant sunscreen if swimming or sweating.
- Sun Protection Meaures. 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 10a.m. - 2 p.m.
-wear long-sleeved shirts, pants, hats, and sunglasses.
Children under 6 monts-age: Ask a doctor
Inactive Ingredient
Inactive ingredients
water, alcohol denat., styrene/acrylates copolymer, dimethicone, acrylates/dimethicone copolymer, tocopherol, dicaprylyl ether, diethyl syringylidenemalonate, phenoxyethanol, caprylyl glycol, PEG-8 laurate, sodium polyacrylate, acrylates/C10-30 alkyl acrylate crosspolymer, trisodium ethylenediamine disuccinate, caprylic/capric triglyceride, methyl lactate, glycerin, sodium dodecylbenzenesulfonate, butylene glycol, pentylene glycol, mentha piperita (peppermint) extract, menthol, moringa oleifera seed extract, methyl salicylate, disodium phosphate, citric acid
Package Label.Principal Display Panel
Medik8
Advanced Day UV protect Sunscreen
Broad Spectrum SPF 50
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