NDC | 69047-001-03, 69047-001-04 |
Set ID | 89370caf-4805-4468-acc7-95f7f8912df1 |
Category | HUMAN OTC DRUG LABEL |
Packager | Iluminage Beauty, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Uses
- Warnings
-
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
- 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)