Protection 50 Body
FDA Label NDC 68479-230

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dermalogica, Inc. for the product Protection 50 Body (NDC 68479-230). 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 other, active ingredients, purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredients

Avobenzone 3.0%,
Octinoxate 7.5%

Purpose

Sunscreen

Uses

  • Helps prevent sunburn.
  • If used as directed with other sun protection measures (see Directions), helps decrease the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only.

Otc - Do Not Use

Do not use on damaged or broken skin.

Otc - When Using

When using this product keep out of eyes. Rinse with water to remove.

Otc - Stop Use

Stop use and ask a doctor if rash occurs.

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.

Directions

  • Apply liberally 30 minutes before sun exposure.
  • Reapply:
    • -At least every two 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 help decrease this risk, regularly use a sunscreen with a 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-sleeve shirts, pants, hats and sunglasses.
      • Children under 6 months: ask a doctor.

Other Information

  • Protect this product from excessive heat and direct sun.

Inactive Ingredients

Water/Aqua/Eau, Butylene Glycol, C12-15 Alkyl Benzoate, Carthamus Tinctorius (Safflower) Oleosomes, Cyclopentasiloxane, Aluminum Starch Octenylsuccinate, Cetearyl Phosphate, Polyglyceryl-2 Stearate, Dimethyl Capramide, VP/Eicosene Copolymer, Artemisia Pallens Flower Oil, Cananga Odorata Flower Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Paradisi (Grapefruit) Peel Oil, Pelargonium Graveolens Flower Oil, Tagetes Minuta Flower Oil, Sodium Hyaluronate, Dipotassium Glycyrrhizate, Caprylic/Capric Glycerides, Arachidyl Alcohol, Behenyl Alcohol, Arachidyl Glucoside, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Xanthan Gum, Disodium EDTA, Sodium Hydroxide, Ethylhexylglycerin, Phenoxyethanol.

Questions Or Comments

Call toll free 1-800-831-5150 in the US

Principal Display Panel - 156 Ml Tube Carton

protection
50

sport

spf
50

broad
spectrum

UVA high protection

5.3 US FL OZ
156 mL e

dermalogica®

Principal Display Panel (156 mL Tube Carton)

Principal Display Panel (156 mL Tube Carton)

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