Label: LAB SERIES SKINCARE FOR MEN BB TINTED MOISTURIZER BROAD SPECTRUM SPF 35- octinoxate, octisalate, oxybenzone, titanium dioxide, and zinc oxide liquid
- NDC Code(s): 42472-011-01
- Packager: Aramis 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 May 23, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
-
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
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Directions
For sunscreen use:
- apply liberally and evenly 15 minutes before sun exposure
- reapply at least every two hours
- use a water resistant sunscreen if swimming or sweating
-
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
- children under 6 months of age: ask a doctor
-
Inactive ingredients
water\aqua\eau•trioctyldodecyl citrate•methyl trimethicone•dimethicone•octyldodecyl stearoyl stearate•butylene glycol•phenyl trimethicone•pentylene glycol•glyceryl stearate•behenyl alcohol•polymethylsilsesquioxane•peg-40 stearate•polyglyceryl-10 pentastearate•acetyl glucosamine•tocopheryl acetate•sodium hyaluronate•lecithin•squalane•sigesbeckia orientalis (st. paul's wort) extract•hordeum vulgare (barley) extract\extrait d'orge• triticum vulgare (wheat) germ extract•laminaria saccharina extract•cucumis sativus (cucumber) fruit extract•pyrus malus (apple) fruit extract•scutellaria baicalensis root extract•caffeine•cholesterol•glycerin•sodium pca•polyglyceryl-6 polyricinoleate•oryzanol•trehalose•octyldodecyl neopentanoate•acetyl hexapeptide-8•propylene glycol stearate•propylene glycol laurate•isopropyl myristate•aluminum hydroxide•sodium stearoyl lactylate•xanthan gum•sucrose•urea•acrylates/ammonium methacrylate copolymer•disodium edta•ammonium acryloyldimethyltaurate/vp copolymer•silica•isopropyl titanium triisostearate•sorbitan laurate•polysorbate 20•polyquaternium-51•stearic acid•linoleic acid•glycyrrhetinic acid•triethyl citrate•triacetin•bht•sodium sulfite•sodium metabisulfite•potassium sorbate•pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate•phenoxyethanol•chlorphenesin•sodium dehydroacetate•[+/- iron oxides (ci 77491)•iron oxides (ci 77492)•iron oxides (ci 77499)•titanium dioxide (ci 77891)] <iln48883>
- Other information
- PRINCIPAL DISPLAY PANEL - 50 ml Bottle Carton
-
INGREDIENTS AND APPEARANCE
LAB SERIES SKINCARE FOR MEN BB TINTED MOISTURIZER BROAD SPECTRUM SPF 35
octinoxate, octisalate, oxybenzone, titanium dioxide, and zinc oxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42472-011 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 40 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 25 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 22 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) PENTYLENE GLYCOL (UNII: 50C1307PZG) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) DOCOSANOL (UNII: 9G1OE216XY) PEG-40 STEARATE (UNII: ECU18C66Q7) N-ACETYLGLUCOSAMINE (UNII: V956696549) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SQUALANE (UNII: GW89575KF9) WHEAT GERM (UNII: YR3G369F5A) SACCHARINA LATISSIMA (UNII: 68CMP2MB55) CUCUMBER (UNII: YY7C30VXJT) APPLE (UNII: B423VGH5S9) SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S) CAFFEINE (UNII: 3G6A5W338E) CHOLESTEROL (UNII: 97C5T2UQ7J) GLYCERIN (UNII: PDC6A3C0OX) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) ORYZANOL (UNII: SST9XCL51M) TREHALOSE (UNII: B8WCK70T7I) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL) PROPYLENE GLYCOL MONOSTEARATE (UNII: MZM1I680W0) PROPYLENE GLYCOL MONOLAURATE (UNII: 668Z5835Z3) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) ALUMINUM OXIDE (UNII: LMI26O6933) SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN) XANTHAN GUM (UNII: TTV12P4NEE) SUCROSE (UNII: C151H8M554) UREA (UNII: 8W8T17847W) EDETATE DISODIUM (UNII: 7FLD91C86K) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I) SORBITAN MONOLAURATE (UNII: 6W9PS8B71J) POLYSORBATE 20 (UNII: 7T1F30V5YH) STEARIC ACID (UNII: 4ELV7Z65AP) LINOLEIC ACID (UNII: 9KJL21T0QJ) ENOXOLONE (UNII: P540XA09DR) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) PHENOXYETHANOL (UNII: HIE492ZZ3T) CHLORPHENESIN (UNII: I670DAL4SZ) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) WATER (UNII: 059QF0KO0R) TRIOCTYLDODECYL CITRATE (UNII: 35X8CT063R) METHYL TRIMETHICONE (UNII: S73ZQI0GXM) DIMETHICONE (UNII: 92RU3N3Y1O) OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42472-011-01 1 in 1 CARTON 11/19/2020 1 50 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 04/24/2011 Labeler - Aramis Inc. (042918826) Registrant - Estee Lauder Companies Inc. (790802086) Establishment Name Address ID/FEI Business Operations Estee Lauder N.V. 370151326 pack(42472-011) , manufacture(42472-011) , label(42472-011)
