Label: YOUTH CELL DAY BROAD SPECTRUM SPF-15 SUNSCREEN- avobenzone, octinoxate, octisalate, and octocrylene cream
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Contains inactivated NDC Code(s)
NDC Code(s): 69047-001-03, 69047-001-04 - 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 January 7, 2015
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Uses
- Warnings
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Directions
- apply liberally 15 minutes before sun exposure
- reapply at least every two hours
- use a water resistant sunscreen if swimming or sweating
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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
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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
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
YOUTH CELL DAY BROAD SPECTRUM SPF-15 SUNSCREEN
avobenzone, octinoxate, octisalate, and octocrylene 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 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)
