Otc - Active Ingredient
Active ingredient Purpose
Homosalate (6.0%)
Octinoxate (7.5%)
Octisalate (5.0%)
Oxybenzone (5.0%)....................Sunscreens
Be Smart Get Prepared Sunscreen
FDA Label NDC 55550-950
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Total Resources International Inc. for the product Be Smart Get Prepared Sunscreen (NDC 55550-950). 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 otc - active ingredient, otc - purpose, warnings, otc - ask doctor, otc - do not use, otc - stop use, otc - keep out of reach of children, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses
- helps prevent sunburn
- higher SPF gives more sunburn protection
- for skin highly sensitive to sunburn
Warnings
Skin cancer/skin aging alert: 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 aging skin.
For external use only.
Otc - Ask Doctor
Stop use and ask a doctor if
- rash occurs.
Otc - Do Not Use
Do not use • on damaged or broken skin.
Otc - Stop Use
Stop use, ask a doctor if
- rash occurs
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
if swallowed, get medical help or contact a poison control center right away.
Indications & Usage
Directions
- apply liberally 15 minutes before sun exposure
- reapply at least every two hours
- use a water resistant sunscreen if swimming or sweating
- children under 6 months: ask a doctor
Other Safety Information
Other Information
- protect this product in this container from excessive heat and direct sun
Inactive Ingredient
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
Be Smart Get Prepared (00 Sun 71615 Front Rev.01)
Be Smart Get Prepared (00 Sun 71615 Back Rev.01)
* Please review the disclaimer below.
