Label: YOUTH CELL DAY CREAM BROAD SPECTRUM SPF-15 SUNSCREEN (50 ML)- spf 15 cream cream
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Contains inactivated NDC Code(s)
NDC Code(s): 69047-001-01, 69047-001-02 - Packager: Iluminage Beauty, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 June 20, 2014
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
-
PRINCIPAL DISPLAY PANEL
Iluminage
POND'S INSTITUTE
YOUTH CELL
DAY CREAM
BROAD SPECTRUM
SPF 15 SUNSCREEN
50 ml e 1 .7 FL. OZ
GO UNDERCOVER IN BROAD DAYLIGHT
After 10 years of genomics research, the Pond’s
Institute scientists have decoded youth DNA
Pathways responsible for the self-renewing
Power of epidermal stem cells. This potent
24-hr hydrating cream contains patented
Survixyl ™ and CLA to help enhance skin’s
natural cell renewal and diminish the visible
signs of aging. Plus, this protective cream
formulated with board spectrum UVA/UVB
filters and vitamin E, helps shield skin from
environmental aggressors such as the sun
and free radicals, What do you see? A visible
reduction in the appearance of fine lines and
wrinkles, a smoother texture and a more
even, radiant skin tone. Apply after using the
SKIN SMOOTHING LASER™ to give skin added
protection.
DERMATOLOGIST TESTED
ADVANCE TECHNOLOGIES
-SURVIXYL™, “The youth cell bodyguard:
Helps support skin’s natural ability to defend
itself against stress and visible signs of aging.
-CLA, “The anti-aging power house”: works
within deepest surface layers to boost skin’s
natural cell renewal.
PROVEN TO CHANGE THE WAY
YOU SEE YOUR SKIN*
-90% of women noticed a smoother skin
Texture.
-73% of women saw a reduction in the
appearance of fine lines and wrinkles
-85% of women saw an enhancement in
skin’s natural radiance
*Consumer in-use test on 119 volunteers (results after 4 weeks).
Made in USA
Distributed by Iluminage™, inc.
243 5th Avenue, Suite #110
New York, NY 10016
Iluminagebeauty.com
I103100 1-855-myiluminage (694-5864)
Drug Facts
Active ingredients
Avobenzone 3%
Octinoxate 6%
Octisalate 3%
Octocrylene 2.4%
Purpose
Sunscreen
Uses
-helps prevent sunburn
If used as directed with other sun
protection measures (See Directions),
decreases the risk of skin cancer and
early skin aging cause by the sun.
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 swallowed,
get medical help or contact a Poison
Control Center right away.
Directions
-apply generously and evenly to face
and neck 15 minutes before sun
exposure.
-reapply at least every 2 hours
-use a water resistant sunscreen if
swimming or sweating.
-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 a sunscreen with a Board
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.
Other information
-protect the product in this container
from excessive heat and direct sun
Drug Facts (continued)
Inactive ingredients
Water/Aqua, Cyclopentasiloxane, Nia-
cinamide, Glycerin, Cetearyl Alcohol,
Dimethicone, PEG-100 Stearate, Poly-
Methylsilsesquixane, Isomerized Linoleic
Acid, Tocopheryl Acetate, Cholesterol,
Stearic Acid, Caprylic/Capric Triglyceride,
Pentapeptide-31, Ammonium
Acryloydimethyltaurate/Beheneth-25
Methylacrylate Crosspolymer, Tocopherol,
Behenyl Alcoho, Palmitic Acid, Linoleic
Acid, Oleic Acid, Ceteareth-20, Butylene
Glycol, Cetyl Alcohol, Stearyl Alcohol,
Arachidyl Alcohol, Ammonium Lactate,
Pentaerythiryl Tetra-di-t-butyl Hydro-
Xyhydrocinnamate, Isohexadecane, Poly-
Methyl Methacrylate, Sodium Polyacry-
Loyldimethyl Taurate, Ethylene/Arcylic
Acid Copolymer, Poloxamer 338, Silica,
Hydrogenated Polydecene, Trideceth-10,
Dimethiconol, Calcium Aluminum
Borosilicate, Methylisothiszolinone, Cap-
prylyl Glycol, Fragrance, Acetamide MEA,
Polyglycerin-3, BHT, Phenoxyethanol,
Propylene Glycol, Sodium Benzoate,
Citric Acid, Disodium EDTA, Limonene,
Linalool, tin Oxide. Titanium Dioxide
(CI 77891).
THE BEAUTY OF SMART™
Award-winning scientists at the Pond’s Institute
have collaborated with a team of luminaries in
the field of dermatology to break the boundaries
of skincare. For the first time, science, technology
and complete interactivity join forces to create
a skincare system so effective it’s the last one
you’ll ever need.
THE ILUMINAGE ™ SKIN CLINIC
Get smart. Visit the Iluminage ™ Skin Clinic for
A complete interactive experience. Access
Iluminage ™ Skin Specialists in person, online,
Or by phone. Plus, maintain your own personal
Progress page online and on-the-go. Join
Our skincare community, participate in
the conversation and see the light at
iluminagebeauty.com
- ACTIVE INGREDIENT
- PURPOSE
- BOXED WARNING (What is this?)
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
-
OTHER SAFETY INFORMATION
-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 a sunscreen with a Board
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.
-
INACTIVE INGREDIENT
Inactive ingredients
Water/Aqua, Cyclopentasiloxane, Nia-
cinamide, Glycerin, Cetearyl Alcohol,
Dimethicone, PEG-100 Stearate, Poly-
Methylsilsesquixane, Isomerized Linoleic
Acid, Tocopheryl Acetate, Cholesterol,
Stearic Acid, Caprylic/Capric Triglyceride,
Pentapeptide-31, Ammonium
Acryloydimethyltaurate/Beheneth-25
Methylacrylate Crosspolymer, Tocopherol,
Behenyl Alcoho, Palmitic Acid, Linoleic
Acid, Oleic Acid, Ceteareth-20, Butylene
Glycol, Cetyl Alcohol, Stearyl Alcohol,
Arachidyl Alcohol, Ammonium Lactate,
Pentaerythiryl Tetra-di-t-butyl Hydro-
Xyhydrocinnamate, Isohexadecane, Poly-
Methyl Methacrylate, Sodium Polyacry-
Loyldimethyl Taurate, Ethylene/Arcylic
Acid Copolymer, Poloxamer 338, Silica,
Hydrogenated Polydecene, Trideceth-10,
Dimethiconol, Calcium Aluminum
Borosilicate, Methylisothiszolinone, Cap-
prylyl Glycol, Fragrance, Acetamide MEA,
Polyglycerin-3, BHT, Phenoxyethanol,
Propylene Glycol, Sodium Benzoate,
Citric Acid, Disodium EDTA, Limonene,
Linalool, tin Oxide. Titanium Dioxide
(CI 77891).
-
INGREDIENTS AND APPEARANCE
YOUTH CELL DAY CREAM BROAD SPECTRUM SPF-15 SUNSCREEN (50 ML)
spf 15 cream creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69047-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 5.994 mg in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 3.000 mg in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 2.400 mg in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3.000 mg in 100 mL Inactive Ingredients Ingredient Name Strength ACETAMIDE (UNII: 8XOE1JSO29) AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER (52000 MPA.S) (UNII: LZ291VH90H) AMMONIUM LACTATE (UNII: 67M901L9NQ) ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) DOCOSANOL (UNII: 9G1OE216XY) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CAPRYLYL GLYCOL (UNII: 00YIU5438U) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETYL ALCOHOL (UNII: 936JST6JCN) CHLORPHENESIN (UNII: I670DAL4SZ) CHOLESTEROL (UNII: 97C5T2UQ7J) CHONDRUS CRISPUS (UNII: OQS23HUA1X) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) CYCLOMETHICONE 6 (UNII: XHK3U310BA) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) CYCLOMETHICONE 4 (UNII: CZ227117JE) DIMETHICONE (UNII: 92RU3N3Y1O) DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7) ISOHEXADECANE (UNII: 918X1OUF1E) LINOLEIC ACID (UNII: 9KJL21T0QJ) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) MICA (UNII: V8A1AW0880) NIACINAMIDE (UNII: 25X51I8RD4) OLEIC ACID (UNII: 2UMI9U37CP) PALMITIC ACID (UNII: 2V16EO95H1) PEG-100 STEARATE (UNII: YD01N1999R) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLOXAMER 338 (UNII: F75JV2T505) POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) STEARIC ACID (UNII: 4ELV7Z65AP) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) TERT-BUTYL ALCOHOL (UNII: MD83SFE959) STANNIC OXIDE (UNII: KM7N50LOS6) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TRIDECETH-10 (UNII: G624N6MSBA) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69047-001-02 1 in 1 BOX 10/16/2013 1 NDC:69047-001-01 50 mL in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 10/16/2013 Labeler - Iluminage Beauty, Inc. (032551374)