ADVANCEDSUNSAFETYSOLUTION- sun safety solution cream 
Shenzhen XiaoMai Manufacturing Co., Ltd.

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Homosalate: 10%
Titanium Dioxide: 5%
Octocrylene: 2%
Zinc Oxide: 9%
Niacinamide: 4%
Ceramide 3: 0.5%
Ceramide 6 II: 0.5%
Ceramide 1: 0.5%
Sodium Hyaluronate: 1.5%
Collagen: 1.5%
Centella Asiatica Extract: 2.5%

PURPOSE

helps prevent sunburn.

Uses

decreases the risk of skin cancer and early skin aging caused by the sun.

WARNINGS

For external use only.

Do not use


on damaged or broken skin.

When using this product

keep out of eyes.
Rinse with water to remove.

Stop use and ask a doctor


if rash occurs.

Keep out of reach of children.


If swallowed, get medicalhelp or contact a Poison Control Center right away.

Directions for use

apply liberally 15 minutes before sun exposure.
reapply at least every 2 hours.
use a water resistant sunscreen if swimming or sweating.

INACTIVE INGREDIENT

Cetearyl Alcohol: 4.5%
Ethylcelluloses: 1%
Carbomer: 0.2%
Disodium EDTA: 0.6%
Glycerin: 5.5%
Dimethicone: 3.5%
Behentrimonium Methosulfate: 1.5%
Aluminum Starch Octenylsuccinate: 2%
Propylparaben: 0.6%
Sodium Lauroyl Aspartate: 0.3%
Phytosphingosine: 0.2%
Lactic Acid: 0.2%
Xanthan Gum: 0.2%
Water: 42.7%

Other Information

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

109

ADVANCEDSUNSAFETYSOLUTION 
sun safety solution cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83872-109
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CERAMIDE 6 II (UNII: F1X8L2B00J) (CERAMIDE 6 II - UNII:F1X8L2B00J) CERAMIDE 6 II5 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE20 mg  in 1 g
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE40 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE90 mg  in 1 g
CERAMIDE 3 (UNII: 4370DF050B) (CERAMIDE 3 - UNII:4370DF050B) CERAMIDE 35 mg  in 1 g
CERAMIDE 1 (UNII: 5THT33P7X7) (CERAMIDE 1 - UNII:5THT33P7X7) CERAMIDE 15 mg  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 55 mg  in 1 g
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) 20 mg  in 1 g
LACTIC ACID (UNII: 33X04XA5AT) 2 mg  in 1 g
DIMETHICONE (UNII: 92RU3N3Y1O) 35 mg  in 1 g
XANTHAN GUM (UNII: TTV12P4NEE) 2 mg  in 1 g
SODIUM LAUROYL ASPARTATE (UNII: 328G13N8ZR) 3 mg  in 1 g
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q) 2 mg  in 1 g
WATER (UNII: 059QF0KO0R) 427 mg  in 1 g
PROPYLPARABEN (UNII: Z8IX2SC1OH) 6 mg  in 1 g
BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61) 15 mg  in 1 g
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83872-109-0150 g in 1 BOTTLE; Type 0: Not a Combination Product04/17/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02004/17/2024
Labeler - Shenzhen XiaoMai Manufacturing Co., Ltd. (712999147)
Establishment
NameAddressID/FEIBusiness Operations
Shenzhen XiaoMai Manufacturing Co., Ltd.712999147manufacture(83872-109)

Revised: 4/2024
Document Id: 164369d7-2098-c9d0-e063-6294a90aa487
Set id: 164369d7-2097-c9d0-e063-6294a90aa487
Version: 1
Effective Time: 20240416
 
Shenzhen XiaoMai Manufacturing Co., Ltd.