Hale Cosmeceuticals Complexion Protection Sunscreen SPF 35

Hale Cosmeceuticals Complexion Protection Sunscreen SPF 35 by

Drug Labeling and Warnings

Hale Cosmeceuticals Complexion Protection Sunscreen SPF 35 by is a Otc medication manufactured, distributed, or labeled by Hale Cosmeceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HALE COSMECEUTICALS COMPLEXION PROTECTION SUNSCREEN SPF 35- titanium dioxide cream 
Hale Cosmeceuticals, Inc.

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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Hale Cosmeceuticals Complexion Protection Sunscreen SPF 35

Drug Facts

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.

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 reach of children.

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

Directions

  • apply liberally 15 minutes before sun exposure 
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • immediately after towel drying 
  • at least every 2 hours 
  • children under 6 months: Ask a doctor 

Skin Cancer/Skin Aging Alert:Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

Other Information

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

Inactive Ingredients

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

Questions or comments?

Visit www.halecosmeceuticals.com or call toll-free (800) 951-7005.

Package Labeling:30ml

Label2

Package Labeling:74ml

Label3

HALE COSMECEUTICALS COMPLEXION PROTECTION SUNSCREEN SPF 35 
titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71987-008
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
WATER (UNII: 059QF0KO0R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
SQUALANE (UNII: GW89575KF9)  
BORAGO OFFICINALIS SEED (UNII: 2GXJ790US0)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SORBIC ACID (UNII: X045WJ989B)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
TOCOPHEROL (UNII: R0ZB2556P8)  
UREA (UNII: 8W8T17847W)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
XANTHAN GUM (UNII: TTV12P4NEE)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 71987-008-0130 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product12/01/202012/31/2024
2NDC: 71987-008-0274 mL in 1 TUBE; Type 0: Not a Combination Product12/01/202012/31/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/01/202012/31/2024
Labeler - Hale Cosmeceuticals, Inc. (168405822)

Revised: 12/2022
Document Id: efcf8feb-77cf-389d-e053-2a95a90a7232
Set id: b5a7c5f4-9219-2ea4-e053-2a95a90a1f97
Version: 3
Effective Time: 20221214