Label: FRESH SKIN EFFORTLESS BEAUTY BALM BROAD SPECTRUM SPF 35- octinoxate, octisalate, oxybenzone, titanium dioxide, and zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 43072-001-01 - Packager: AERIN LAUDER BEAUTY DIST.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 December 19, 2014
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Use
- Warnings
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Directions
For sunscreen use:
- 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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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
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Inactive ingredients
water\aqua\eau • dimethicone • butylene glycol • phenyl trimethicone • pentylene glycol • glyceryl stearate • behenyl alcohol • trioctyldodecyl citrate • polymethylsilsesquioxane • octyldodecyl stearoyl stearate • peg-40 stearate • polyglyceryl-10 pentastearate • tocopheryl acetate • sodium hyaluronate • lecithin • squalane • triticum vulgare (wheat) germ extract • hordeum vulgare (barley) extract\extrait d'orge • cucumis sativus (cucumber) fruit extract • laminaria saccharina extract • pyrus malus (apple) fruit extract • scutellaria baicalensis root extract • glycerin • caffeine • cholesterol • oryzanol • trehalose • octyldodecyl neopentanoate • polyglyceryl-6 polyricinoleate • acetyl hexapeptide-8 • sodium pca • sucrose • urea • polyquaternium-51 • sodium stearoyl lactylate • ammonium acryloyldimethyltaurate/vp copolymer • polysorbate 20 • sorbitan laurate • propylene glycol laurate • glycyrrhetinic acid • linoleic acid • stearic acid • xanthan gum • silica • isopropyl titanium triisostearate • alumina • propylene glycol stearate • disodium edta • sodium dehydroacetate • chlorphenesin • phenoxyethanol • [+/- mica • iron oxides (ci 77491) • iron oxides (ci 77492) • iron oxides (ci 77499) • titanium dioxide (ci 77891)] <iln41064>
- Other information
- PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton
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INGREDIENTS AND APPEARANCE
FRESH SKIN EFFORTLESS BEAUTY BALM BROAD SPECTRUM SPF 35
octinoxate, octisalate, oxybenzone, titanium dioxide, and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43072-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.08175 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 0.0436 g in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.02725 g in 100 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.01199 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.03597 g in 100 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) dimethicone (UNII: 92RU3N3Y1O) butylene glycol (UNII: 3XUS85K0RA) phenyl trimethicone (UNII: DR0K5NOJ4R) pentylene glycol (UNII: 50C1307PZG) glyceryl monostearate (UNII: 230OU9XXE4) docosanol (UNII: 9G1OE216XY) trioctyldodecyl citrate (UNII: 35X8CT063R) octyldodecyl stearoyl stearate (UNII: 3D47Q6D93C) peg-40 stearate (UNII: ECU18C66Q7) .alpha.-tocopherol acetate (UNII: 9E8X80D2L0) hyaluronate sodium (UNII: YSE9PPT4TH) squalane (UNII: GW89575KF9) wheat germ (UNII: YR3G369F5A) barley (UNII: 5PWM7YLI7R) cucumber (UNII: YY7C30VXJT) saccharina latissima (UNII: 68CMP2MB55) apple (UNII: B423VGH5S9) scutellaria baicalensis root (UNII: 7J95K7ID2S) glycerin (UNII: PDC6A3C0OX) caffeine (UNII: 3G6A5W338E) cholesterol (UNII: 97C5T2UQ7J) gamma oryzanol (UNII: SST9XCL51M) trehalose (UNII: B8WCK70T7I) octyldodecyl neopentanoate (UNII: X8725R883T) acetyl hexapeptide-8 (UNII: L4EL31FWIL) sodium pyrrolidone carboxylate (UNII: 469OTG57A2) sucrose (UNII: C151H8M554) urea (UNII: 8W8T17847W) sodium stearoyl lactylate (UNII: IN99IT31LN) ammonium acryloyldimethyltaurate/vp copolymer (UNII: W59H9296ZG) polysorbate 20 (UNII: 7T1F30V5YH) sorbitan monolaurate (UNII: 6W9PS8B71J) propylene glycol monolaurate (UNII: 668Z5835Z3) enoxolone (UNII: P540XA09DR) linoleic acid (UNII: 9KJL21T0QJ) stearic acid (UNII: 4ELV7Z65AP) xanthan gum (UNII: TTV12P4NEE) silicon dioxide (UNII: ETJ7Z6XBU4) isopropyl titanium triisostearate (UNII: 949E3KBJ1I) aluminum oxide (UNII: LMI26O6933) propylene glycol stearate (UNII: MZM1I680W0) edetate disodium (UNII: 7FLD91C86K) sodium dehydroacetate (UNII: 8W46YN971G) chlorphenesin (UNII: I670DAL4SZ) phenoxyethanol (UNII: HIE492ZZ3T) mica (UNII: V8A1AW0880) ferric oxide red (UNII: 1K09F3G675) ferric oxide yellow (UNII: EX438O2MRT) ferrosoferric oxide (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43072-001-01 1 in 1 CARTON 1 50 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 12/01/2014 Labeler - AERIN LAUDER BEAUTY DIST. (078518500) Establishment Name Address ID/FEI Business Operations ELGC K.K. 712808195 RELABEL(43072-001) , REPACK(43072-001) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COMPANY, THE 828534516 RELABEL(43072-001) , REPACK(43072-001) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 244669714 MANUFACTURE(43072-001) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD. 202952982 MANUFACTURE(43072-001) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER N.V. 370151326 MANUFACTURE(43072-001) Establishment Name Address ID/FEI Business Operations LEN-RON MANUFACTURING DIVISION OF ARAMIS INC 809771152 MANUFACTURE(43072-001) Establishment Name Address ID/FEI Business Operations NORTHTEC INC 943871157 RELABEL(43072-001) , REPACK(43072-001) Establishment Name Address ID/FEI Business Operations NORTHTEC LLC 959338336 MANUFACTURE(43072-001) Establishment Name Address ID/FEI Business Operations PADC 1 949264774 RELABEL(43072-001) , REPACK(43072-001) Establishment Name Address ID/FEI Business Operations WHITMAN LABORATORIES, LTD. 216866277 MANUFACTURE(43072-001) Establishment Name Address ID/FEI Business Operations Aveda Corporation 071352058 MANUFACTURE(43072-001) Establishment Name Address ID/FEI Business Operations Pennsylvania Logistics Center (PALC) 078364654 REPACK(43072-001) , RELABEL(43072-001) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 255175580 MANUFACTURE(43072-001)
