Sunscreen Lotion
FDA Label NDC 61010-6103

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Safetec Of America, Inc. for the product Sunscreen (NDC 61010-6103). 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 - stop use, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient

Homosalate (6.0%)

Octinoxate (7.5%)

Octisalate (5.0%)

Oxybenzone (5.0%)

Purpose

Sunscreens

Uses

  • helps prevent sunburn
  • higher SPF gives more sunburn protection
  • for skin highly sensitive to sunburn

Warnings

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

For external use only.

Otc - Do Not Use

Do not use on damaged or broken skin.

Otc - Stop Use

Stop use and ask a doctor if rash occurs.

When Using This Product

  • keep out of eyes
  • rinse with water to remove

Keep Out Of Reach Of Children.

If 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 two hours
  • children under 6 months: ask a doctor
  • protect from excessive heat and direct sun

Inactive Ingredients

cetyl alcohol, ganex P-904, germaben II, petrolatum, polyoxyl 40 stearate, polysorbate 60, purified water, sorbitan monostearate, tetrasodium EDTA, titanium dioxide, xanthan gum, zenicone XX

Package Label.Principal Display Panel

PRINCIPAL DISPLAY PANEL – 25 count box

NDC 61010-6103-1

Safetec

Sunscreen
Lotion
SPF 30

PABA Free

25 Packets

3.5 g (1/8 oz.)

Reorder no. 53700

PRINCIPAL DISPLAY PANEL – packet

Safetec

Sunscreen
Lotion
SPF 30•PABA Free
3.5g (1/8 oz.)

Safetec of America, Inc.
Buffalo, NY 14215 800-456-7077
www.safetec.com

* Please review the disclaimer below.