FLAWLESS BRIGHTENING SUNSCREEN NON-TINTED- titanium dioxide, zinc oxide cream 
Flawless Skin Care LLC (dba Abby Skin Care)

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DRUG FACTS

ACTIVE INGREDIENTS:

Titanium Dioxide 8%

Zinc Oxide 3.8%

PURPOSE:

Sunscreen

Sunscreen

USES:

Helps prevent sunburn. If used as directed with other sun protection measures (see directions), 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. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove. Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

INACTIVE INGREDIENTS:

Alumina, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Lauryl PEG/PPG-18/18 Methicone, Hydrogen Dimethicone, PEG-10 Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate

OTHER INFORMATION:

Principal Display Panel - 53 g Bottle Label

ABBY SKIN CARE

ABBY ODIAMAR PACLIBAR

FLAWLESS
BRIGHTENING
SUNSCREEN

NON-TINTED

SPF 40 Broad Spectrum

Water Resistant (80 Minutes)

Oil Free Facial Mineral Sunscreen

Paraben Free

Reef Friendly

Net Wt 1.8 oz/53 g

Principal Display Panel - 53 g Bottle Label
FLAWLESS BRIGHTENING SUNSCREEN NON-TINTED 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81535-202
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide80 mg  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide38 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Aluminum Hydroxide (UNII: 5QB0T2IUN0)  
Cyclomethicone 6 (UNII: XHK3U310BA)  
Cyclomethicone 5 (UNII: 0THT5PCI0R)  
Dimethicone 20 (UNII: H8YMB5QY0D)  
Dimethicone Crosspolymer (450000 MPA.S AT 12% in Cyclopentasiloxane) (UNII: UF7620L1W6)  
Dimethicone/Vinyl Dimethicone Crosspolymer (Soft Particle) (UNII: 9E4CO0W6C5)  
Dimethiconol (2000 CST) (UNII: T74O12AN6Y)  
Lauryl PEG/PPG-18/18 Methicone (UNII: ZJ5S27D9NX)  
Hydrogen Dimethicone (20 CST) (UNII: 12Z59IF64N)  
PEG-10 Dimethicone (600 CST) (UNII: 8PR7V1SVM0)  
Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ)  
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81535-202-5053 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/19/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35209/19/2019
Labeler - Flawless Skin Care LLC (dba Abby Skin Care) (031934930)
Establishment
NameAddressID/FEIBusiness Operations
Custom Analytics LLC144949372ANALYSIS(81535-202)
Establishment
NameAddressID/FEIBusiness Operations
Fragrance Manufacturing Inc. (FMI)793406000MANUFACTURE(81535-202) , PACK(81535-202)

Revised: 5/2020
Document Id: 583fe650-3b55-4e14-a272-4fa6a68584ea
Set id: 2855a775-a1fe-4e8e-9dc4-7838ca1073e3
Version: 1
Effective Time: 20200525
 
Flawless Skin Care LLC (dba Abby Skin Care)