FATAZEN Sunscreen Lip Balm Stick by Guangzhou Guocui Biological Technology Co., Ltd. 83885-005

FATAZEN Sunscreen Lip Balm Stick by

Drug Labeling and Warnings

FATAZEN Sunscreen Lip Balm Stick by is a Otc medication manufactured, distributed, or labeled by Guangzhou Guocui Biological Technology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FATAZEN SUNSCREEN LIP BALM STICK- fatazen sunscreen lip balm stick lipstick 
Guangzhou Guocui Biological Technology Co., Ltd.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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83885-005

Active Ingredient(s)

EthylhexyI salicylate
Octocrylene

Purpose

sunscreen

Use

Moisturizes and prevents sunburn

Warnings

For external use only.

Do not use

in children less than 2 months of age

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 iritation or rash occurs. These may
be signs of a serious condition.
Keep out of reach of children. If swallowved, get medical help or
contact a Poison Control Center right away.

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

Keep out of reach of children

Directions

Before going out, apply a sufficient amount of sunscreen lip
balm on your lips to moisturize your lips and effectively prevent
UV damage to your lips. Supervise children under 6 years of
age when using this product to avoid swallowing.Store between
15- 30C (59-86F)

Other information

No data

Inactive ingredients

EthyhexyI palmitate, tridecyl trelliate,t disostetary malate,
squalane, polyetylene, beeswax. phytosterals, tocopheryl
acelate, (daily) fragrance

FATAZEN SUNSCREEN LIP BALM STICK 
fatazen sunscreen lip balm stick lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83885-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	7 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	9 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SQUALANE (UNII: GW89575KF9)
YELLOW WAX (UNII: 2ZA36H0S2V)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
FRAGRANCE 13576 (UNII: 5EM498GW35)
SITOSTEROLS (UNII: G7V636VTDY)
HEXADIMETHRINE BROMIDE (UNII: 4C905MSK4W)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83885-005-01	5 g in 1 CANISTER; Type 0: Not a Combination Product	04/17/2024	02/14/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/17/2024	02/14/2025

Labeler - Guangzhou Guocui Biological Technology Co., Ltd. (419547269)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Guocui Biological Technology Co., Ltd.		419547269	manufacture(83885-005)

Revised: 2/2025

Document Id: 2e168a49-0282-bb4b-e063-6394a90a71cc

34390-5

Set id: 164665d0-a689-155d-e063-6294a90aeabf

Version: 2

Effective Time: 20250214

 

Guangzho