FDA.reportPublic FDA data

Hale Cosmeceuticals Complexion Protection Sunscreen SPF 35

Manufacturer
Hale Cosmeceuticals, Inc.
Effective date
2022-12-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:44:29

Label at a glance#

ProductHale Cosmeceuticals Complexion Protection Sunscreen SPF 35
Active ingredientTITANIUM DIOXIDE
Label structure9 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 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 o...

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.

Warnings

WARNINGS SECTION

  • For external use only

Do not use

OTC - DO NOT USE SECTION

  • on damaged or broken skin

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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.

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
  • 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

SPL UNCLASSIFIED SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

  • 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.

Package Labeling:30ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

Package Labeling:74ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label3Label3

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71987-00871987-008-01, 71987-008-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
STEARIC ACID4ELV7Z65APIACT
ALUMINUM OXIDELMI26O6933IACT
SQUALANEGW89575KF9IACT
BORAGO OFFICINALIS SEED2GXJ790US0IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
HYALURONATE SODIUMYSE9PPT4THIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
GLYCERINPDC6A3C0OXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
SORBIC ACIDX045WJ989BIACT
OLIVE OIL6UYK2W1W1EIACT
TOCOPHEROLR0ZB2556P8IACT
UREA8W8T17847WIACT
CETYL ALCOHOL936JST6JCNIACT
XANTHAN GUMTTV12P4NEEIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
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
efcf8feb-77cf-389d-e053-2a95a90a7232b5a7c5f4-9219-2ea4-e053-2a95a90a1f972022-12-14WarningsExact identifier
spl id: efcf8feb-77cf-389d-e053-2a95a90a7232
spl set id: b5a7c5f4-9219-2ea4-e053-2a95a90a1f97

Reported adverse events (FAERS/openFDA)#

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