Otc - Active Ingredient
AVOBENZONE G63QQF2NOX 2.9%
OCTISALATE 4X49Y0596W 4.9%
OCTOCRYLENE 5A68WGF6WM 9.5%
Sunscreen Setting Spritz, Spf 45 Liquid
FDA Label NDC 70000-1543
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health, Inc. for the product Sunscreen Setting Spritz, Spf 45 (NDC 70000-1543). 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, inactive ingredient, otc - purpose, warnings, otc - stop use, otc - do not 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
Inactive Ingredient
WATER
BHT
ALCOHOL
PEG-400
PROPYLENE GLYCOL LAURATE
Otc - Purpose
WATER
BHT
ALCOHOL
PEG-400
PROPYLENE GLYCOL LAURATE
Warnings
Warnings
For external use only Do not use on damaged or broken skin.
When using this product: keep out of eyes, Rinse with water to remove.
Stop use and ask a doctor if rash occurs.
Keep out of reach of children.lf swallowed, get medical help or contacta Poison Control
Center right away
Flammable. Do not spray near heat sparks, sources of ignition, or flames
Otc - Stop Use
For external use only Do not use on damaged or broken skin.
When using this product: keep out of eyes, Rinse with water to remove.
Stop use and ask a doctor if rash occurs.
Otc - Do Not Use
Keep out of reach of children.lf swallowed, get medical help or contacta Poison Control
Center right away
Flammable. Do not spray near heat sparks, sources of ignition, or flames
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.lf swallowed, get medical help or contacta Poison Control
Center right away
Flammable. Do not spray near heat sparks, sources of ignition, or flames
Indications & Usage
Directions
Apply liberally 15 minutes before sun exposure. Reaooly. at least every 2 hours or after
80 minutes ofswimming or sweating.Sun Protection Measures, Spending time in the sun
increases your riskof skan cancer and early skin aging. lo decrease this risk, regularly
use asunscreen with a Broad Spectrum SPF value of 15 or higher and other
sunprotection measures including, limit time in sun, especiallv from 10 a.m.-2p.m, and
wear long-sleeved shirts, pants, hats, and sunalasses. Chitdrenunder 6 months of age:
ask a doctor.
Dosage & Administration
Apply tiberally 15 minutes before sun exposure.
Reapoly. at least every 2 hours or after 80 minutes of swimming or sweating.
Otc - When Using
When using this product: keep out of eyes, Rinse with water to remave.
Stop use and ask a doctor if rash occurs.
* Please review the disclaimer below.
