HYDRATING SUNSCREEN spray

HYDRATING SUNSCREEN by

Drug Labeling and Warnings

HYDRATING SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by Guangzhou Yapeng Refinement Chemical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Avobenzone 3%

Homosalate 10%

Octocrylene 8%

Octilsalate 5%

Purpose

sunscreen

Use

USES:
Helps prevent sunburn. If used as directed with other sun protection measures (see directions),
decreases the risk of skin cancer and early skin ageing caused by the sun.

Warnings

Do not use

in children less than 2 months of age on open skin wounds.

WHEN USING

When using this product keep out of eyes, ears, and mouth. In case of contact with
eyes, rinse eyes thoroughly with water. Stop use and ask a doctor if irritation or
rash occurs. These may be signs of a serious condition. Keep out of reach of
children. If swallowed, get medical help or contact a Poison Control Center right away.

STOP USE

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a
serious condition.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison
Control C enter right away.

Directions

DIRECTION:
1.Shake the spray bottle well before use.

2.Hold the spray bottle at an appropriate distance from the face and neck. Spray evenly onto the entire face and neck area.

3.Avoid direct contact with eyes. In case of eye contact, rinse immediately with water.
4.For continued sun protection, reapply every 2 hours.

Other information

• Protect the product in this container from excessive heat and direct sun.
  

Inactive ingredients

INACTIVE INGREDIENTS:

Auqa, Methacrylate Copolymer, Alcohol Denat, Bisabolol, Hyaluronic Acid,

D- Alpha-tocopheryl acetate, Terminalia Ferdinandiana, Butyloctyl Salicylate,
Sebacic Acid Copolymer, Dicaprylyl Ether, Diheptyl Succinate, Disooctyl Succinate,
Ethyl Ferulat, IsononyI Isononanoate, Pelargonium Graveolens Flower Oil.

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

HYDRATING SUNSCREEN 
hydrating sunscreen spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84356-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	8 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
KAKADU PLUM (UNII: 0ZQ1D2FDLI)
AMMONIO METHACRYLATE COPOLYMER TYPE A (UNII: 8GQS4E66YY)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
LEVOMENOL (UNII: 24WE03BX2T)
HYALURONIC ACID (UNII: S270N0TRQY)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84356-001-01	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/30/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/30/2024

Labeler - Guangzhou Yapeng Refinement Chemical Co., Ltd. (529423510)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Yapeng Refinement Chemical Co., Ltd.		529423510	manufacture(84356-001)