COMPLEXION PROTECTION MOISTURIZING SUNSCREEN- titanium dioxide cream

Complexion Protection Moisturizing Sunscreen by

Drug Labeling and Warnings

Complexion Protection Moisturizing Sunscreen by is a Otc medication manufactured, distributed, or labeled by Hale Comeceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Titanium Dioxide 7.5%

Purpose

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.

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

• apply liberally 15 minutes before sun exposure
• use a water resistant sunscreen if swimming or sweating
• reapply at least every 2 hours
• reapply : 
• after 40 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours
• children under 6 months : Ask a doctor
• Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
• limit time in the sun, especially from 10 a.m. - 2 p.m.
• wear long-sleeved shirts, pants, hats, and sunglass
• children under 6 months: Ask a doctor.    

Other Information

• protect this product from excessive heat and direct sun
• may stain some fabrics.

Questions or comments?

Scan the QR Code below,

visit www.halecosmeceuticals.com,

or call toll-free 800-951-7005.

Package Labeling

INGREDIENTS AND APPEARANCE

COMPLEXION PROTECTION MOISTURIZING SUNSCREEN 
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71987-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	75 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71987-001-00	74 mL in 1 TUBE; Type 0: Not a Combination Product	01/09/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/09/2018

Labeler - Hale Comeceuticals (168405822)