YOUTH CELL DAY BROAD SPECTRUM SPF-15 SUNSCREEN- avobenzone, octinoxate, octisalate, and octocrylene cream 
Iluminage Beauty, Inc.

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.

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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 caused 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

     - limit time in the sun, especially from 10 a.m.–2 p.m.  

     - wear long-sleeved shirts, pants, hats and sunglasses                                

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).

Other information

protect the product in this container from excessive heat and direct sun

Label

3 mL packette

YOUTH CELL DAY  BROAD SPECTRUM SPF-15 SUNSCREEN
avobenzone, octinoxate, octisalate, and octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69047-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6 mg  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE3 mg  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.4 mg  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69047-001-041 in 1 CARTON10/16/2013
1NDC:69047-001-033 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/16/2013
Labeler - Iluminage Beauty, Inc. (032551374)

Revised: 1/2015
Document Id: fabf51b3-fc51-407f-82f7-6c4704a89775
Set id: 89370caf-4805-4468-acc7-95f7f8912df1
Version: 5
Effective Time: 20150107
 
Iluminage Beauty, Inc.