COMPLEXION PROTECTION MOISTURIZING SUNSCREEN- titanium dioxide cream 
Hale Comeceuticals

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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Complexion Protection Moisturizing Sunscreen

Active Ingredients

Titanium Dioxide 7.5%

Purpose

Sunscreen

Uses

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 reach of children

If swallowed, get medical help or contact a poison Control Center right away.

Inactive Ingredients

Alumina, Borago Officinalis Seed Oil, Caprylic/Capric Triglyceride, Caprylyl Glycol, Ceteareth-20, Catearyl Alcohol, Cetyl Alcohol, Disodium EDTA, Glycerin, Glyceryl Stearate, Hydrogenated Vegetable Oil, Olea Europaea (Olive) Fruit Oil, PEG-100 Stearate, Phenoxyethanol, Polyhydroxystearic Acid, Squalane, Sodium Hyaluronate, Sorbic Acid, Stearic Acid, Tocopheryl Acetate, Urea, Water, Xanthan Gum.

Directions

Other Information

Questions or comments?

Scan the QR Code below,

visit www.halecosmeceuticals.com,

or call toll-free 800-951-7005.

Package Labeling

Label 001

COMPLEXION PROTECTION MOISTURIZING SUNSCREEN 
titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71987-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE75 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALUMINUM OXIDE (UNII: LMI26O6933)  
BORAGE SEED OIL (UNII: F8XAG1755S)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SQUALANE (UNII: GW89575KF9)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
SORBIC ACID (UNII: X045WJ989B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
UREA (UNII: 8W8T17847W)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71987-001-0074 mL in 1 TUBE; Type 0: Not a Combination Product01/09/201812/31/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/09/201812/31/2024
Labeler - Hale Comeceuticals (168405822)

Revised: 12/2022
Document Id: efcf5a31-7511-d233-e053-2a95a90a9c52
Set id: c36450c2-1a10-4cd9-94ce-5fa42c3e9c23
Version: 3
Effective Time: 20221214
 
Hale Comeceuticals