TRIENELLE SKINCARE DAILY RENEWAL CREME WITH TOCALLURE RESTORATION COMPLEX BROAD SPECTRUM SPF 15- octinoxate 5%, oxybezone 4.5%, avobenzone 3% cream 
NewMarket Health Products LLC

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.

----------

Trienelle Skincare Daily Renewal Creme

Drug Facts


Active Ingredient

Octinoxate 5.0%

Oxybenzone 4.5%

Avobenzone 3.0%

Purpose

Sunscreen

Uses

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

Inactive Ingredients

Water, Glycerin, C12-15 Alkyl Benzoate, Phenyl Trimethicone, Cyclomethicone, Tocotrienol, Dimethicone, PEG-100 Stearate, Glyceryl Stearate, Tocopherol, Cetearyl Alcohol, Cetyl Alcohol, Vaccinium Myrtillus Fruit and Leaf Extract, Chlorella Vulgaris Extract, Ganoderma Lucidum (Mushroom) Stem Extract, Trametes Versicolor Extract, Saccharum Officinarum Extract, Acer Sacharinum Extract, Citrus Aurantium Dulcis Fruit Extract, Citrus Limon Extract, Palmitoyl Pentapeptide, Superoxide Dismutase, Stevia Rebaudiana Extract, Foeniculum Vulgare Extract, Hydrolyzed Algin, Applephenone, Salix Alba (Bark) Extract, Colostrum, Melatonin, Squalene, Elaies Guineensis Oil, Phytosterols, Sea Water, Phospholipids, Butylene Glycol, Triacontanyl PVP, Phenoxyethenol, Xanthan Gum, Ceteareth-20, Carbomer, Polysorbate-20, Methylparaben, Butylparaben, Propylparaben, Ethylparaben, Tetrasodium EDTA, Triethanolamine

Other Information

Distributed by

Trienelle Skincare, Inc.

702 Cathedral St.

Baltimore, MD 21201

1-800-539-5195

www.trienelle.com

Trienelle Skincare

Daily Renewal Creme

WITH TOCALLURE RESTORATION COMPLEX

Broad Spectrum SPF 15

Formulated to:

Visibly rejuvenate your skin to help reduce the signs of aging

Net. 50 ml (1.7 fl oz)

Daily Renewal Box

TRIENELLE SKINCARE DAILY RENEWAL CREME  WITH TOCALLURE RESTORATION COMPLEX BROAD SPECTRUM SPF 15
octinoxate 5%, oxybezone 4.5%, avobenzone 3% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50972-736
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE4.5 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
TOCOTRIENOLS (UNII: KP2MW85SSQ)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PEG-100 STEARATE (UNII: YD01N1999R)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
TOCOPHEROL (UNII: R0ZB2556P8)  
VACCINIUM MYRTILLUS FRUITING TOP (UNII: QT6362QVN8)  
VACCINIUM MYRTILLUS LEAF (UNII: Y4U591OU70)  
CHLORELLA VULGARIS (UNII: RYQ4R60M02)  
GANODERMA LUCIDUM STEM (UNII: U8PA41532G)  
TRAMETES VERSICOLOR FRUITING BODY (UNII: 4C900477MT)  
SUGARCANE (UNII: 81H2R5AOH3)  
ACER SACCHARINUM WHOLE (UNII: 3PIN4S77JQ)  
ORANGE (UNII: 5EVU04N5QU)  
LEMON (UNII: 24RS0A988O)  
PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG)  
SUPEROXIDE DISMUTASE (CU-ZN) SACCHAROMYCES CEREVISIAE (UNII: ZQP6EKT6WD)  
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
FOENICULUM VULGARE WHOLE (UNII: J1UK54JBGH)  
LAMINARIA DIGITATA HYDROLYZED ALGINIC ACID (UNII: 9E3P882579)  
APPLE (UNII: B423VGH5S9)  
SALIX ALBA BARK (UNII: 205MXS71H7)  
BOS TAURUS COLOSTRUM (UNII: S256WJ3OFQ)  
MELATONIN (UNII: JL5DK93RCL)  
SQUALENE (UNII: 7QWM220FJH)  
PALM OIL (UNII: 5QUO05548Z)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCINE MAX WHOLE (UNII: NID9NUV93F)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
TRICONTANYL POVIDONE (UNII: N0SS3Q238D)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
XANTHAN GUM (UNII: TTV12P4NEE)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
ETHYLPARABEN (UNII: 14255EXE39)  
EDETATE SODIUM (UNII: MP1J8420LU)  
TROLAMINE (UNII: 9O3K93S3TK)  
Product Characteristics
Colorwhite (off-white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50972-736-011 in 1 BOX
150 g in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35209/29/2014
Labeler - NewMarket Health Products LLC (828825989)
Establishment
NameAddressID/FEIBusiness Operations
Biogenesis Labs069117328manufacture(50972-736)

Revised: 9/2014
Document Id: 0034d5d4-3de7-4dc5-be59-974c10940ca2
Set id: 258674f6-5303-4a1c-a4a3-039b81eb2015
Version: 1
Effective Time: 20140929
 
NewMarket Health Products LLC