NDC | 55118-605-11, 55118-605-77 |
Set ID | 10908d34-9a32-4907-859b-abb822b2a84f |
Category | HUMAN OTC DRUG LABEL |
Packager | Kimberly-Clark |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
-
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
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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
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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?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label
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INGREDIENTS AND APPEARANCE
TRUIST SUNSCREEN MOISTURIZER
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotionProduct 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)