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

Youth Cell Day by

Drug Labeling and Warnings

Youth Cell Day by is a Otc medication manufactured, distributed, or labeled by Iluminage Beauty, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

• apply liberally 15 minutes before sun exposure
• reapply at least every two 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 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                                

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

PRINCIPAL DISPLAY PANEL

Label

INGREDIENTS AND APPEARANCE

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

Product 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	6 mg  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	3 mg  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.4 mg  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 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: 69047-001-04	1 in 1 CARTON	10/16/2013
1	NDC: 69047-001-03	3 mL in 1 PACKET

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)