FDA.reportPublic FDA data

82723-001 Face SPF 47 Setting Spray

Manufacturer
Aopline Health Industry Technology (Guangzhou) Co., Ltd.
Effective date
2025-01-08
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:51:38

Label at a glance#

ProductFace SPF 47 Setting
Active ingredientOCTOCRYLENE, AVOBENZONE, OCTISALATE, HOMOSALATE
Label structure12 sections

Indications and uses

Helps prevent sunburn. If used as directed with other sun protection measures, decrease the risk of skin cancer and early skin aging caused by sun.

Dosage and administration

•Apply to face 15 minutes before sun exposure. Reapply every 2 hours.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Homosalate 8.0%

Octisalate 5.0%

Octocrylene 3.0%

Avobenzone 3.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn. If used as directed with other sun protection measures, decrease the risk of skin cancer and early skin aging caused by sun.

Warnings

WARNINGS SECTION

For External Use Only.

Do not use on damaged or broken skin.

Keep out of reach of children.

Keep out of eyes. Rinse with water to remove.

Stop use and ask a physician if rash occurs.

Keep out of reach of children . If product is swallowed, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

•Apply to face 15 minutes before sun exposure.

Reapply every 2 hours.

Other Information

OTHER SAFETY INFORMATION

Children under 6 months ask a physician.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Vitamin E, Vitamin C, Hyaluronic Acid, Niacinamide, Peppermint Extract, Eucalyptus Extract, Sunflower Seed Oil, Tea Tree Extract, Alcohol, Cyclohexasiloxane, Cyclopentasiloxane, Ethylhexyl Palmitate

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Stop use

OTC - STOP USE SECTION

Stop use and ask a physician if rash occurs.

OTC - WHEN USING SECTION

For External Use Only.

Do not use on damaged or broken skin.

Keep out of reach of children.

Keep out of eyes. Rinse with water to remove.

Stop use and ask a physician if rash occurs.

Keep out of reach of children . If product is swallowed, get medical help or contact a Poison Control Center immediately.

Do not use

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

82723-001-01 50mL82723-001-01 50mL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82723-001-012024-11-18C16284748780-11030e365-1f25-111a-e063-dadaa90a10e282723-001 Face SPF 47 Setting Spray
82723-001-012024-01-30C16284748780-11030e365-1f25-111a-e063-dadaa90a10e282723-001 Face SPF 47 Setting Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82723-001-01Face SPF 47 Setting50 mL in 1 BOTTLESPRAY504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82723-001FACE SPF 47 SETTING (FACE SPF 47 SETTING SPRAY) SPRAY [AOPLINE HEALTH INDUSTRY TECHNOLOGY (GUANGZHOU) CO., LTD.]4Legacy NDC, 1 package rows20250110_de66edea-b435-a9df-e053-2995a90a4205.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82723-00182723-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
EUCALYPTUS GLOBULUS LEAFS546YLW6E6IACT
SUNFLOWER OIL3W1JG795YIIACT
ALCOHOL3K9958V90MIACT
CYCLOMETHICONE 6XHK3U310BAIACT
MELALEUCA ALTERNIFOLIA LEAFG43C57162KIACT
ETHYLHEXYL PALMITATE2865993309IACT
ALPHA-TOCOPHEROLH4N855PNZ1IACT
HYALURONIC ACIDS270N0TRQYIACT
PEPPERMINTV95R5KMY2BIACT
CYCLOMETHICONE 50THT5PCI0RIACT
NIACINAMIDE25X51I8RD4IACT
ASCORBIC ACIDPQ6CK8PD0RIACT
OCTOCRYLENE5A68WGF6WMACTIB
AVOBENZONEG63QQF2NOXACTIB
OCTISALATE4X49Y0596WACTIB
HOMOSALATEV06SV4M95SACTIB

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
2b3c1720-1665-e338-e063-6394a90ae436de66edea-b435-a9df-e053-2995a90a42052025-01-08WarningsExact identifier
spl id: 2b3c1720-1665-e338-e063-6394a90ae436
spl set id: de66edea-b435-a9df-e053-2995a90a4205

Reported adverse events (FAERS/openFDA)#

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