OTC Medication Information: Hale Cosmeceuticals Complexion Perfection Sunscreen SPF 20

HALE COSMECEUTICALS COMPLEXION PERFECTION SUNSCREEN SPF 20- 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.

Drug Facts

Active Ingredients

Titanium Dioxide 5.0%

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

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, Glyceryl Stearate, PEG-100 Stearate, Cetearyl Alcohol, Ceteareth-20, Borago Officinalis Seed Oil, Sodium Hyaluronate, Iron Oxide, Niacinamide, Glycerin, Tocopheryl Acetate, Kojic Dipalmitate, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Olea Europaea (Olive) Fruit Oil, Hydrogenated Vegetable Oil, Tocopheryl, Hydroxypropyl Cyclodextrin, Palmitoyl Tripeptide-38, Urea, Xanthum Gum, Disodium EDTA.

Questions or comments?

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

Package Labeling:

Bottle
(click image for full-size original)

HALE COSMECEUTICALS COMPLEXION PERFECTION SUNSCREEN SPF 20
titanium dioxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71987-007
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
MEDIUM-CHAIN TRIGLYCERIDES
POLYHYDROXYSTEARIC ACID (2300 MW)
STEARIC ACID
ALUMINUM OXIDE
SQUALANE
GLYCERYL MONOSTEARATE
PEG-100 STEARATE
CETOSTEARYL ALCOHOL
POLYOXYL 20 CETOSTEARYL ETHER
BORAGO OFFICINALIS SEED
HYALURONATE SODIUM
FERRIC OXIDE RED
NIACINAMIDE
GLYCERIN
.ALPHA.-TOCOPHEROL ACETATE
KOJIC DIPALMITATE
PHENOXYETHANOL
CAPRYLYL GLYCOL
SORBIC ACID
OLIVE OIL
TOCOPHEROL
PALMITOYL LYSYLDIOXYMETHIONYLLYSINE
UREA
XANTHAN GUM
EDETATE DISODIUM ANHYDROUS
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71987-007-01 30 mL in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 12/01/2020 12/31/2024
Labeler — Hale Cosmeceuticals, Inc. (168405822)

Revised: 12/2022 Hale Cosmeceuticals, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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