TRUIST SUNSCREEN MOISTURIZER- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

Truist Sunscreen Moisturizer by

Drug Labeling and Warnings

Truist Sunscreen Moisturizer by is a Otc medication manufactured, distributed, or labeled by Kimberly-Clark. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Avobenzone 3%

Homosalate 8%

Octisalate 5%

Octocrylene 2.7%

Oxybenzone 3%

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.

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children. If product is 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.
• 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 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 sunglasses.

Other Information

Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

Water (Aqua), C12-15 Alkyl Benzoate, Isononyl Isononanoate, Glycerin, Tropaeolum Majus Extract, Coffea Arabica (Coffee) Seed Extract, Zanthoxylum Alatum Fruit Extract, Tamarindus Indica Seed Polysaccharide, Dipotassium Glycyrrhizate, Glutamylamidoethyl Imidazole, Madecassoside, Asiaticoside, Silica, Sodium Hyaluronate Crosspolymer, Tribehenin PEG-20 Esters, Potassium Cetyl Phosphate, Glyceryl Stearate, PEG-100 Stearate, Dimethicone, Carbomer, Cetearyl Alcohol, Trisodium Ethylenediamine Disuccinate, Aminomethyl Propanol, Caprylyl Glycol, Pentylene Glycol, Ethylhexylglycerin, Phenoxyethanol, Chlorphenesin.

Questions or comments?

1-855-878-4782

SPL UNCLASSIFIED SECTION

Distributed by:
Kimberly-Clark Global Sales, LLC
2100 Winchester Road, Dept. SG
Neenah, WI 54956

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

truist™

care

sunscreen
moisturizer
Broad Spectrum SPF 30

4 FL OZ (118 mL)

INGREDIENTS AND APPEARANCE

TRUIST SUNSCREEN MOISTURIZER 
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55118-605
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	80 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	27 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
Isononyl Isononanoate (UNII: S4V5BS6GCX)
Glycerin (UNII: PDC6A3C0OX)
Tropaeolum Majus (UNII: 9G6ZOS4L87)
Arabica Coffee Bean (UNII: 3SW678MX72)
ZANTHOXYLUM ARMATUM FRUIT (UNII: ER3FV125H7)
Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX)
Asiaticoside (UNII: PKO39VY215)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Hyaluronate Sodium (UNII: YSE9PPT4TH)
Tribehenin PEG-20 Esters (UNII: 84K9EH29Y9)
Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)
Glyceryl Monostearate (UNII: 230OU9XXE4)
PEG-100 Stearate (UNII: YD01N1999R)
Dimethicone (UNII: 92RU3N3Y1O)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Trisodium Ethylenediamine Disuccinate (UNII: YA22H34H9Q)
Phenoxyethanol (UNII: HIE492ZZ3T)
Aminomethylpropanol (UNII: LU49E6626Q)
Caprylyl Glycol (UNII: 00YIU5438U)
Pentylene Glycol (UNII: 50C1307PZG)
Ethylhexylglycerin (UNII: 147D247K3P)
Chlorphenesin (UNII: I670DAL4SZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55118-605-11	44 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/20/2013
2	NDC: 55118-605-77	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/20/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	06/20/2013

Labeler - Kimberly-Clark (830997032)