FDA.reportPublic FDA data

Complexion Protection

Manufacturer
Hale Comeceuticals
Effective date
2022-12-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:44:28

Label at a glance#

ProductComplexion Protection
Active ingredientTITANIUM DIOXIDE
Label structure8 sections

Indications and 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.

Dosage and administration

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...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 7.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

Stop use and ask a doctor

OTC - STOP USE SECTION

if rash occurs

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove

keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Alumina, Borago Officinalis Seed Oil, Capric/Caprylic 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

DOSAGE & ADMINISTRATION SECTION

  • 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

SPL UNCLASSIFIED SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Scan the QR Code below,

visit www.halecosmeceuticals.com,

or call toll-free 800-951-7005.

Package Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 000Label 000

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71987-00071987-000-00

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALUMINUM OXIDELMI26O6933IACT
BORAGE SEED OILF8XAG1755SIACT
CAPRYLYL GLYCOL00YIU5438UIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETYL ALCOHOL936JST6JCNIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
OLIVE OIL6UYK2W1W1EIACT
PEG-100 STEARATEYD01N1999RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SQUALANEGW89575KF9IACT
HYALURONATE SODIUMYSE9PPT4THIACT
SORBIC ACIDX045WJ989BIACT
STEARIC ACID4ELV7Z65APIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
UREA8W8T17847WIACT
WATER059QF0KO0RIACT
XANTHAN GUMTTV12P4NEEIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
efcf4345-6ecf-88f7-e053-2a95a90a3c1caff97f2d-68bd-46f8-8654-add3f59ce0ee2022-12-14WarningsExact identifier
spl id: efcf4345-6ecf-88f7-e053-2a95a90a3c1c
spl set id: aff97f2d-68bd-46f8-8654-add3f59ce0ee

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.