Derma E Sun Drops Spf 30 Lotion
FDA Label NDC 54108-1488

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Derma E for the product Derma E Sun Drops Spf 30 (NDC 54108-1488). 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 ingredient, purpose, uses, warnings, otc - do not use, otc - when using, otc - 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

Other

Drug Facts

Distributed by DERMA E®
North Amityville, NY 11701, USA

Active Ingredient

Zinc Oxide 22%

Purpose

Sunscreen

Uses

  • Helps prevent sunburns
  • 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.

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 - Keep Out Of Reach Of Children

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Shake well before each use
  • Apply liberally 15 minutes before sun exposure.
  • Reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours when exposed to sun
    • 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 children under 6 months: Ask a doctor

Inactive Ingredients

Aqua, C12-15 Alkyl Benzoate, Dicaprylyl Carbonate, Caprylic/Capric Triglyceride, Propanediol, Polyglyceryl-10-Stearate, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Glyceryl Hydrogenated Rosinate, Polyglyceryl-2 Dipolyhydroxystearate, Glyceryl Caprylate, Jojoba Esters, Isostearic Acid, Polyhydroxystearic Acid, Polyglyceryl-3 Polyricinoleate, Aloe Barbadensis Leaf Juice, Tapioca Starch, Glycerin, Capryloyl Glycerin/Sebacic Acid Copolymer, Lecithin, Sorbitan Sesquioleate, Tocopherol, Bisabolol, Caprylhydroxamic Acid, Sodium Phytate.

Other Information

  • Protect this product from excessive heat and direct sun.

Principal Display Panel - 50 Ml Bottle Carton

ESSENTIALS

DERMA • E

Daily Sun Serum
SPF 30

broad spectrum UVA/UVB
mineral sunscreen lotion

DERMATOLOGIST
RECOMMENDED

50 mL
NPN #80147356

Principal Display Panel (50 mL Bottle Carton)

Principal Display Panel (50 mL Bottle Carton)

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