FACE SPF 47 SETTING- face spf 47 setting spray spray

Face SPF 47 Setting by

Drug Labeling and Warnings

Face SPF 47 Setting 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 Ingredients

Homosalate 8.0%

Octisalate 5.0%

Octocrylene 3.0%

Avobenzone 3.0%

Purpose

Sunscreen

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.

Warnings

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

Apply to face 15 minutes before sun exposure.

Reapply every 2 hours.

Other Information

Children under 6 months ask a physician.

Inactive Ingredients

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.

Keep out of reach of children.

Stop use

Stop use and ask a physician if rash occurs.

WHEN USING

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

Do not use on damaged or broken skin.

Package Label

INGREDIENTS AND APPEARANCE

FACE SPF 47 SETTING 
face spf 47 setting spray spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82723-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	3 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	8 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ALCOHOL (UNII: 3K9958V90M)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
HYALURONIC ACID (UNII: S270N0TRQY)
PEPPERMINT (UNII: V95R5KMY2B)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
NIACINAMIDE (UNII: 25X51I8RD4)
ASCORBIC ACID (UNII: PQ6CK8PD0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82723-001-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/07/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/07/2022

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(82723-001)