ANTI AGING SPF MOISTRUIZER- avobenzone, homosalate, octisalate, octinoxate cream

Anti Aging SPF Moistruizer by

Drug Labeling and Warnings

Anti Aging SPF Moistruizer by is a Otc medication manufactured, distributed, or labeled by Twinluxe,LLC, PhytogenX,Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients:

Avabenzone 2.5%}

Homosalate 5.0 %}

Octinoxate 7.0%}

Octisalate 5.0%}

Purpose

Sunscreen

Uses:

• helps prevent sunburn
• provides protection from UVA rays that may contribute to skin damage and premature aging of skin

Warnings:

For External use only.

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

If rash or irritation develops, stop use and ask doctor.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

• apply evenly before sun exposure reapply as needed or after towel drying, swimming or perspiring
• children under 6 months of age - ask a doctor

Inactive Ingredients:

Water (Aqua), Pentylene Glycol, Silica, PEG-100 Stearate, Butyrospermum Parkii (Shea Butter), Cetearyl Alcohol, Glyceryl Stearate, Caprylic/Capric Triglyceride, Stearic Acid, Cetyl Phosphate, Malus Domestical Fruit Cell Culture Extract, Di-C12-15 Alkyl Fumarate, Caprylyl Glycol, Hexylene Glycol, Ethylhexylglycerin, Aminomethyl Propanol, Sodium Ascorbyl Phosphate, Salix Alba (Willow) Bark Extract, Centella Asiatica Leaf Extract, Hydrolyzed Rice Protein, Hydroxylpropyl Cyclodextrin, Palmitoyl Tripeptide-38, Camellia Sinensis (White) Tea Leaf Extract, Biotin, Sodium Hyaluronate Crossploymer, Leontopodium Alpinum Meristem Cell Culture, Buddleja Davidii Leaf Cell Culture Extract, Mannitol, Xanthan Gum, Glycerin, Lecithin, Carbomer, Disodium EDTA, Phenoxyethanol

Questions or Comments?

+1 949.502.3754       www.twinluxe.com

Principal Display Panel - 50mL Carton Label

TWINLUXE

Anti-Aging

SPF Moisturizer

SPF 40 Face

Broad Spectrum UVA/UVB

PA +++

50 ml / 1.67 fl oz

INGREDIENTS AND APPEARANCE

ANTI AGING SPF MOISTRUIZER 
avobenzone, homosalate, octisalate, octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59145-773
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	0.025 mg  in 1 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	0.050 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	0.050 mg  in 1 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.070 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Butylene Glycol (UNII: 3XUS85K0RA)
Pentylene Glycol (UNII: 50C1307PZG)
Medium-Chain Triglycerides (UNII: C9H2L21V7U)
glycerin (UNII: PDC6A3C0OX)
Peg-100 Stearate (UNII: YD01N1999R)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Laricifomes Officinalis Fruiting Body (UNII: 7IFM8431X3)
Shea Butter (UNII: K49155WL9Y)
DI-C12-15 alkyl fumarate (UNII: A1CB3Z898P)
laminaria digitata (UNII: 15E7C67EE8)
palmitoyl oligopeptide (UNII: HO4ZT5S86C)
palmitoyl tetrapeptide-7 (UNII: Q41S464P1R)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Cetyl Phosphate (UNII: VT07D6X67O)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
Tocopherol (UNII: R0ZB2556P8)
Milk Thistle (UNII: U946SH95EE)
Omega-3 fatty acids (UNII: 71M78END5S)
biotin (UNII: 6SO6U10H04)
Eucalyptus Oil (UNII: 2R04ONI662)
ergothioneine (UNII: BDZ3DQM98W)
carnosine (UNII: 8HO6PVN24W)
stearic acid (UNII: 4ELV7Z65AP)
polysorbate 20 (UNII: 7T1F30V5YH)
ethylhexylglycerin (UNII: 147D247K3P)
caprylyl glycol (UNII: 00YIU5438U)
Carbomer Homopolymer Type B (Allyl Sucrose Crosslinked) (UNII: Z135WT9208)
mannitol (UNII: 3OWL53L36A)
Edetate Disodium (UNII: 7FLD91C86K)
Aminomethylpropanol (UNII: LU49E6626Q)
phenoxyethanol (UNII: HIE492ZZ3T)
hexylene glycol (UNII: KEH0A3F75J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59145-773-01	1 in 1 BOX
1		1 in 1 CARTON
1		50 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/01/2012

Labeler - Twinluxe,LLC (067301363)

Registrant - PhytogenX,Inc (010297942)

Establishment
Name	Address	ID/FEI	Business Operations
PhytogenX,Inc		010297942	MANUFACTURE(59145-773)