AGELOC ELEMENTS- avobenzone, homosalate, octisalate, and octocrylene kit

ageLOC Elements by

Drug Labeling and Warnings

ageLOC Elements by is a Otc medication manufactured, distributed, or labeled by NSE Products, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Avobenzone (3%), Homosalate (5%), Octisalate (4%), Octocrylene (2%).

Purpose

Sunscreen

Use

• Helps prevent sunburn. Higher SPF gives more sunburn protection
• 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

• For external use only.

• Do not use on damaged or broken skin.

• Stop use and ask a doctor if rash occurs.

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

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

Directions

• Illuminate your skin each day. To complete your morning regimen, squeeze a pea-sized amount onto fingertips and apply in an upward, outward motion to face and neck. Avoid eye area.
• Sunprotection 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.
  • 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.

Inactive Ingredients

Water (Aqua), Glycerin, Cetyl Dimethicone, Cyclopentasiloxane, Acrylamide/Sodium Acryloyldimethyltaurate Copolymer, Caprylyl Glycol, Glyceryl Stearate, PEG-100 Stearate, Dimethicone, Cyclohexasiloxane, Dimethicone/Vinyl Dimethicone Crosspolymer, Cetyl Alcohol, Methyl Gluceth-10, Steareth-2, Steareth-21, Isohexadecane, Nylon-12, Hydrolyzed Jojoba Esters, Jojoba Esters, Bambusa Vulgaris Leaf/Stem Extract, Glucosamine HCl, Pisum Sativum (Pea) Extract, Hexapeptide-2, Narcissus Tazetta Bulb Extract, Schizandra Chinensis Fruit Extract, Butyrospermum Parkii (Shea Butter), Polysorbate 80, Titanium Dioxide, Butylene Glycol, Citric Acid, Disodium EDTA, Fragrance (Parfum), Chlorphenesin, Phenoxyethanol.

Questions

1-888-742-7626

PRINCIPAL DISPLAY PANEL - Kit Carton

ageLOC® ELEMENTS

GENTLE CLEANSE & TONE
RADIANT DAY
TRANSFORMING NIGHT

NU SKIN®

INGREDIENTS AND APPEARANCE

AGELOC ELEMENTS 
avobenzone, homosalate, octisalate, and octocrylene kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62839-3887

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62839-3887-1	1 in 1 CARTON	05/01/2013

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE, WITH APPLICATOR	25 mL
Part 2	1 BOTTLE, PUMP	60 mL
Part 3	1 JAR	30 mL

Part 1 of 3

NU SKIN AGELOC RADIANT DAY BROAD SPECTRUM SPF 22 
avobenzone, homosalate, octisalate, and octocrylene lotion

Product Information
Item Code (Source)	NDC: 62839-3904
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	50 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	40 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
Cyclomethicone 5 (UNII: 0THT5PCI0R)
Caprylyl Glycol (UNII: 00YIU5438U)
Glyceryl Monostearate (UNII: 230OU9XXE4)
PEG-100 Stearate (UNII: YD01N1999R)
Cetyl Alcohol (UNII: 936JST6JCN)
Methyl Gluceth-10 (UNII: N0MWT4C7WH)
Steareth-2 (UNII: V56DFE46J5)
Steareth-21 (UNII: 53J3F32P58)
Isohexadecane (UNII: 918X1OUF1E)
Dimethicone (UNII: 92RU3N3Y1O)
Nylon-12 (UNII: 446U8J075B)
Phenoxyethanol (UNII: HIE492ZZ3T)
Chlorphenesin (UNII: I670DAL4SZ)
Cyclomethicone 6 (UNII: XHK3U310BA)
Polysorbate 80 (UNII: 6OZP39ZG8H)
Glucosamine Hydrochloride (UNII: 750W5330FY)
Shea Butter (UNII: K49155WL9Y)
Titanium Dioxide (UNII: 15FIX9V2JP)
Pea (UNII: W4X7H8GYFM)
Butylene Glycol (UNII: 3XUS85K0RA)
Edetate Disodium (UNII: 7FLD91C86K)
Bambusa Vulgaris Top (UNII: FIW80T6P6V)
Narcissus Tazetta Bulb (UNII: K17762966S)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Schisandra Chinensis Fruit (UNII: ABS794681C)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62839-3904-1	25 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	05/01/2013

Part 2 of 3

AGELOC GENTLE CLEANSE AND TONE 
cleansing (cold creams, cleansing lotions, liquids, and pads) liquid

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	Water (UNII: 059QF0KO0R)
INGR	Glycerin (UNII: PDC6A3C0OX)
INGR	Cocamidopropyl Hydroxysultaine (UNII: 62V75NI93W)
INGR	Betaine (UNII: 3SCV180C9W)
INGR	Sodium Methyl Cocoyl Taurate (UNII: JVL98CG53G)
INGR	Disodium Laureth Sulfosuccinate (UNII: D6DH1DTN7E)
INGR	1,2-Hexanediol (UNII: TR046Y3K1G)
INGR	Caprylyl Glycol (UNII: 00YIU5438U)
INGR	Polysorbate 20 (UNII: 7T1F30V5YH)
INGR	Sodium Benzoate (UNII: OJ245FE5EU)
INGR	Citric Acid Monohydrate (UNII: 2968PHW8QP)
INGR	Edetate Disodium (UNII: 7FLD91C86K)
INGR	Narcissus Tazetta Bulb (UNII: K17762966S)
INGR	Schisandra Chinensis Fruit (UNII: ABS794681C)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		60 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		05/01/2013

Part 3 of 3

AGELOC TRANSFORMING NIGHT 
night cream

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	Water (UNII: 059QF0KO0R)
INGR	Glycerin (UNII: PDC6A3C0OX)
INGR	Pentylene Glycol (UNII: 50C1307PZG)
INGR	Caprylyl Trisiloxane (UNII: Q95M2P1KJL)
INGR	Cyclomethicone 5 (UNII: 0THT5PCI0R)
INGR	Shea Butter (UNII: K49155WL9Y)
INGR	Medium-Chain Triglycerides (UNII: C9H2L21V7U)
INGR	Ammonium Acryloyldimethyltaurate/VP Copolymer (UNII: W59H9296ZG)
INGR	Sorbitol (UNII: 506T60A25R)
INGR	Chlorphenesin (UNII: I670DAL4SZ)
INGR	Hydroxymethyl Cellulose (UNII: 273FM27VK1)
INGR	Glucosamine Hydrochloride (UNII: 750W5330FY)
INGR	Squalane (UNII: GW89575KF9)
INGR	Xanthan Gum (UNII: TTV12P4NEE)
INGR	Pea (UNII: W4X7H8GYFM)
INGR	Edetate Sodium (UNII: MP1J8420LU)
INGR	Bambusa Vulgaris Top (UNII: FIW80T6P6V)
INGR	Narcissus Tazetta Bulb (UNII: K17762966S)
INGR	Citric Acid Monohydrate (UNII: 2968PHW8QP)
INGR	Schisandra Chinensis Fruit (UNII: ABS794681C)
INGR	Hyaluronate Sodium (UNII: YSE9PPT4TH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		30 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		05/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/01/2013

Labeler - NSE Products, Inc. (803486393)