FDA.reportPublic FDA data

Sunscreen Setting Spritz, SPF 45

Manufacturer
Cardinal Health, inc.
Effective date
2025-12-31
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:29:37

Label at a glance#

ProductSunscreen Setting Spritz, SPF 45
Active ingredientAVOBENZONE, OCTISALATE, OCTOCRYLENE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION


AVOBENZONE G63QQF2NOX 2.9%
OCTISALATE 4X49Y0596W 4.9%
OCTOCRYLENE 5A68WGF6WM 9.5%

INACTIVE INGREDIENT SECTION


WATER
BHT
ALCOHOL
PEG-400
PROPYLENE GLYCOL LAURATE

OTC - PURPOSE SECTION

WATER
BHT
ALCOHOL
PEG-400
PROPYLENE GLYCOL LAURATE

WARNINGS SECTION

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 SECTION


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 SECTION


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 SECTION


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 SECTION


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 SECTION


Apply tiberally 15 minutes before sun exposure.
Reapoly. at least every 2 hours or after 80 minutes of swimming or sweating.

OTC - WHEN USING SECTION


When using this product: keep out of eyes, Rinse with water to remave.
Stop use and ask a doctor if rash occurs.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

70000-0281-1Sunscreen setting spray70000-0281-1Sunscreen setting spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-1543-1Sunscreen Setting Spritz, SPF 4560 mL in 1 BOTTLELIQUID603

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-154370000-1543-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL LAURATE668Z5835Z3IACT
ALCOHOL3K9958V90MIACT
AVOBENZONEG63QQF2NOXACTIB
BHT1P9D0Z171KIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
AQUA059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sunscreen Setting Spritz, SPF 45SUNSCREEN SETTING SPRAYCardinal Health, inc.293e9656-8644-b9aa-e063-6294a90a5b272025-12-31WarningsExact identifier
ndc (package): 70000-1543-1
ndc (product): 70000-1543
ndc11 (package): 70000154301
spl id: 473c8f4e-69ca-3e14-e063-6294a90aa371
spl set id: 293e9656-8644-b9aa-e063-6294a90a5b27

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.