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.

----------

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

label

FATAZEN SUNSCREEN LIP BALM STICK 
fatazen sunscreen lip balm stick lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83885-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE7 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE9 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SQUALANE (UNII: GW89575KF9)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
FRAGRANCE 13576 (UNII: 5EM498GW35)  
SITOSTEROLS (UNII: G7V636VTDY)  
HEXADIMETHRINE BROMIDE (UNII: 4C905MSK4W)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83885-005-015 g in 1 CANISTER; Type 0: Not a Combination Product04/17/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/17/2024
Labeler - Guangzhou Guocui Biological Technology Co., Ltd. (419547269)
Establishment
NameAddressID/FEIBusiness Operations
Guangzhou Guocui Biological Technology Co., Ltd.419547269manufacture(83885-005)

Revised: 4/2024
Document Id: 16467084-f710-17cd-e063-6294a90a128a
Set id: 164665d0-a689-155d-e063-6294a90aeabf
Version: 1
Effective Time: 20240417
 
Guangzhou Guocui Biological Technology Co., Ltd.