Antioxidant Sunscreen Spf 40 Lotion
FDA Label NDC 51326-829

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topiderm, Inc. for the product Antioxidant Sunscreen Spf 40 (NDC 51326-829). 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, otc - purpose, uses, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Otc - Purpose

Active ingredientsPurpose
Octinoxate 7.5%Sunscreen
Zinc Oxide 7.0%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.

Otc - When Using

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

Otc - Stop Use

Stop use if signs of irritation or rash appear.If irritation or rash persists consult a doctor.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

  • Apply liberally 15 minutes before sun exposure
  • Re-apply after 80 minutes of swimming or sweating, anytime after towel drying, or at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating
  • Use on children under 6 months of age: consult a doctor.
  • 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 of 15 or higher and other sunscreen measures including:
    • limit time in the sun, especially from 10 a.m. - 2 p.m.
    • wear long-sleeve shirts, pants, hats, and sunglasses

Inactive Ingredients

Ascorbic Acid, Ascorbyl Palmitate, Butylene Glycol, Camellia Sinensis (Green Tea) Leaf Extract, C12-15 Alkyl Benzoate, C13-14 Isoparaffin, Ceresin, Chitosan, Cyclomethicone, Diazolidinyl Urea, Disodium EDTA, Laureth-7, Lauryl PEG/PPG-18/18 Methicone, Methylparaben, Phospholipids, Polyacrylamide, Propyl Gallate, Propylene Glycol, Propylparaben, Purified Water, Retinyl Palmitate, Sodium Chloride, Superdioxide Dismutase, Tocopheryl Acetate, Ubiquinone (Co Q-10).

Principal Display Panel - 105 Ml Bottle Label

CITRIX®

VITAMIN C
ANTIOXIDANT SUNSCREEN
BROAD SPECTRUM SPF 40

UVA & UVB Protection
Micronized Zinc Oxide
Water Resistant (80 minutes)

POLYMER MATRIX TECHNOLOGY

Net 3.5 fl. oz. (105 ml)
Topix Pharmaceuticals, Inc. | N. Amityville, NY 11701

Principal Display Panel (105 ml Bottle Label)

Principal Display Panel (105 ml Bottle Label)

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