Extreme Protect Spf 30 Lotion
FDA Label NDC 69219-103

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Science Of Skincare Llc for the product Extreme Protect Spf 30 (NDC 69219-103). 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 active ingredients, purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, 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

Active Ingredients

Octinoxate – 5.50%

Zinc Oxide – 4.12%

Purpose

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 - 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.

    • • Use a water resistant sunscreen if swimming or sweating

    • Reapply 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:
    o limit time in the sun, especially from 10 a.m.-2 p.m.
    o 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.

Questions Or Comments?

Call Customer Care at (888) 804-4447

Inactive Ingredients

Water, Polyacrylamide, Tocopherol, Ethylhexyl Palmitate, PPG-3 Myristyl Ether, Cetyl Alcohol, Glycol Stearate SE, VP/Hexadecene Copolymer, Olea Europaea (Olive) Leaf Extract, Aloe Barbadensis Leaf Juice, Asiaticoside, Asiatic Acd, Madecassic Acid, Sodium Dihydrocetyl Phosphate, Ethyl Linoleate, Oleyl Alcohol, Glyceryl Stearate, Octyldodecyl Neopentanoate, Caprylyl Glycol, Hexylene Glycol, PEG-100 Stearate, C13-14 Isoparaffin, Laureth-7, Phenoxyethanol.

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