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

Trienelle Skincare Daily Renewal Creme by

Drug Labeling and Warnings

Trienelle Skincare Daily Renewal Creme by is a Otc medication manufactured, distributed, or labeled by NewMarket Health Products LLC, Biogenesis Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Octinoxate 5.0%

Oxybenzone 4.5%

Avobenzone 3.0%

PURPOSE

Purpose

Sunscreen

INDICATIONS & USAGE

Uses

• Helps prevent sunburn
• Higher SPF gives more sunburn protection

WARNINGS

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.

DOSAGE & ADMINISTRATION

Directions

• Apply cream evenly twice daily to the face, neck, and other exposed areas before exposure to sun.
• Children under 6 months of age: 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 sunscreen with a Broad Spectrum SPF value 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
• reapply at least every 2 hours
• use a water resistant sunscreen if swimming or sweating. 

INACTIVE INGREDIENT

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 SAFETY INFORMATION

Other Information

• Sun Alert: Limiting sun exposure, wearing protective clothing and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.
• Protect the product in this container from excessive heat and direct sun.

QUESTIONS

Distributed by

Trienelle Skincare, Inc.

702 Cathedral St.

Baltimore, MD 21201

1-800-539-5195

www.trienelle.com

PRINCIPAL DISPLAY PANEL

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)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50972-736
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	5 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4.5 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	white (off-white)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50972-736-01	1 in 1 BOX
1		50 g in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/29/2014

Labeler - NewMarket Health Products LLC (828825989)

Establishment
Name	Address	ID/FEI	Business Operations
Biogenesis Labs		069117328	manufacture(50972-736)