Label: TRIENELLE SKINCARE DAILY RENEWAL CREME WITH TOCALLURE RESTORATION COMPLEX BROAD SPECTRUM SPF 15- octinoxate 5%, oxybezone 4.5%, avobenzone 3% cream
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Contains inactivated NDC Code(s)
NDC Code(s): 50972-736-01 - Packager: NewMarket Health Products LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated September 29, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
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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.
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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
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TRIENELLE SKINCARE DAILY RENEWAL CREME WITH TOCALLURE RESTORATION COMPLEX BROAD SPECTRUM SPF 15
octinoxate 5%, oxybezone 4.5%, avobenzone 3% creamProduct 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)
