78 X 36 Spf 30 Active Cream
FDA Label NDC 58466-109

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dermazone Llc for the product 78 X 36 Spf 30 Active (NDC 58466-109). 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

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DRUG FACTS

Active Ingredients

Zinc Oxide 20%

Purpose

Sunscreen

Uses

Helps prevent sunburn

lf used as directed with other sun protection measures (see Directions),decreases the risk of skin cancer and early 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 product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply liberally 15 minutes before sun exposure. Reapply:

  • *Immediately after towel drying
  • *At least every 2 hours

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 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 the product in this container from excessive heat and direct sunlight.

Inactive Ingredients

Acetyl Ethylhexyl Polyhydroxystearate, Alcohol, Artemia Extract, C9-12 Alkane, Caprylic/Capric Triglycerides, Coco-Caprylate/Caprate, Ethylhexylglycerin,Fragrance, Glycerin, Isoamyl Laurate, Lecithin, Phenoxyethanol, Polyurethane-100, Potassium Cetyl Phosphate, Purified Water, Silica, Sodium Chloride, Sorbitan Olivate, Triheptanoin, Xanthan Gum.

Principal Display Panel - 96 G Tube Carton

BROAD SPECTRUM

78 x 36

SPF 30
ACTIVE

PROTECT YOUR SKIN
PROTECT YOUR GAME

SPORTS
SWEAT PROTECTION
80 MINUTES

3.4 OZ
96g

Principal Display Panel (96 g Tube Carton)

Principal Display Panel (96 g Tube Carton)

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