SUNSCREEN SETTING SPRITZ, SPF 45- sunscreen setting spray liquid

Sunscreen Setting Spritz, SPF 45 by

Drug Labeling and Warnings

Sunscreen Setting Spritz, SPF 45 by is a Otc medication manufactured, distributed, or labeled by Aopline Health Industry Technology (Guangzhou) Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

Sunscreen+ Setting Spritz

INDICATIONS & USAGE

Uses
Helps prevent sunburn.
|f used as directed with other sun protection measures (see Directions)decreases the risk of skin cancer and early skin aging caused by the sun.

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

DOSAGE & ADMINISTRATION

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

INACTIVE INGREDIENT

WATER
BHT
ALCOHOL
PEG-400
PROPYLENE GLYCOL LAURATE

STOP USE

DO NOT USE

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.lf swallowed, get medical help or contacta Poison Control Center right away

WHEN USING

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUNSCREEN SETTING SPRITZ, SPF 45 
sunscreen setting spray liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82723-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.74 g  in 60 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.94 g  in 60 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5.7 g  in 60 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
PROPYLENE GLYCOL LAURATE (UNII: 668Z5835Z3)
BHT (UNII: 1P9D0Z171K)
PEG-400 (UNII: B697894SGQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82723-011-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/08/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/08/2024

Labeler - Aopline Health Industry Technology (Guangzhou) Co., Ltd. (715076108)

Establishment
Name	Address	ID/FEI	Business Operations
Aopline Health Industry Technology (Guangzhou) Co., Ltd.		715076108	manufacture(82723-011)