81522-228 Sunscreen Setting Spritz, Spf 45

81522-228 Sunscreen Setting Spritz, Spf 45
SPL v1
SPL
SPL Set ID 473d6804-8d20-6899-e063-6294a90a3131
Route
TOPICAL
Published
Effective Date 2025-12-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (2.94 g) Avobenzone (1.74 g) Octocrylene (5.7 g)
Inactive Ingredients
Polyethylene Glycol 400 Propylene Glycol Laurate Aqua Alcohol Bht

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-30

Description

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


Medication Information

Warnings and Precautions

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

Indications and 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 and Administration

Apply tiberally 15 minutes before sun exposure.

Reapoly. at least every 2 hours or after 80 minutes of swimming or sweating.

Description

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

Section 50565-1

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

Section 51727-6

WATER

BHT

ALCOHOL

PEG-400

PROPYLENE GLYCOL LAURATE

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9



AVOBENZONE G63QQF2NOX 2.9%

OCTISALATE 4X49Y0596W 4.9%

OCTOCRYLENE 5A68WGF6WM 9.5%


Structured Label Content

Indications and Usage (34067-9)

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 and Administration (34068-7)

Apply tiberally 15 minutes before sun exposure.

Reapoly. at least every 2 hours or after 80 minutes of swimming or sweating.

Warnings and Precautions (34071-1)

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

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

WATER

BHT

ALCOHOL

PEG-400

PROPYLENE GLYCOL LAURATE

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)



AVOBENZONE G63QQF2NOX 2.9%

OCTISALATE 4X49Y0596W 4.9%

OCTOCRYLENE 5A68WGF6WM 9.5%


Advanced Ingredient Data


Raw Label Data

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