Label: ADVANCED TIME ZONE AGE REVERSING LINE WRINKLE BROAD SPECTRUM SPF 15 DRY SKIN- avobenzone, octisalate, and octocrylene cream
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Contains inactivated NDC Code(s)
NDC Code(s): 11559-020-01 - Packager: ESTEE LAUDER INC
- 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 September 4, 2012
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 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 • butyrospermum parkii (shea butter) • butylene glycol • di-c12-15 alkyl fumarate • steareth-21 • pentaerythrityl tetraethylhexanoate • sucrose • cetyl alcohol • glycerin • neopentyl glycol diethylhexanoate • hdi/ppg/polycaprolactone crosspolymer • steareth-2 • acrylamide/sodium acryloyldimethyltaurate copolymer • polyethylene • citrullus vulgaris (watermelon) fruit extract • sigesbeckia orientalis (st. paul's wort) extract • pyrus malus (apple) fruit extract • lens esculenta (lentil) fruit extract • centaurium erythraea (centaury) extract • laminaria digitata extract • hordeum vulgare (barley) extract\extrait d'orge • cucumis sativus (cucumber) fruit extract • tamarindus indica seed extract • salicornia herbacea extract • polygonum cuspidatum root extract • vitis vinifera (grape) seed extract • hydrolyzed rice extract • rosmarinus officinalis (rosemary) extract • selaginella tamariscina (spike moss) extract • humulus lupulus (hops) extract • citrus reticulata (tangerine) peel extract • yeast extract\faex\extrait de levure • limonium vulgare flower/leaf/stem extract • whey protein\lactis protein\proteine du petit-lait • thermus thermophillus ferment • punica granatum (pomegranate) fruit juice • cholesterol • linoleic acid • caffeine • acetyl glucosamine • linolenic acid • adenosine phosphate • lactoperoxidase • phospholipids • acetyl hexapeptide-8 • glucose oxidase • tocopheryl acetate • triolein • cetyl dimethicone • phytantriol • trehalose • ppg-15 stearyl ether • pvp/hexadecene copolymer • caprylic/capric triglyceride • ethylhexylglycerin • polysilicone-11 • isohexadecane • caprylyl glycol • propylene glycol dicaprate • sodium pca • helianthus annuus (sunflower) seedcake • propylene glycol heptanoate • polysorbate 80 • acrylates/c10-30 alkyl acrylate crosspolymer • glucose • neopentyl glycol diisostearate • sodium hyaluronate • sodium lactate • phytosteryl canola glycerides • oleic acid • palmitic acid • stearic acid • potassium sulfate • decarboxy carnosine hcl • nordihydroguaiaretic acid • cyclodextrin • tromethamine • hexylene glycol • fragrance (parfum) • silica • ethylbisiminomethylguaiacol manganese chloride • dipentaerythrityl tri-polyhydroxystearate • disodium edta • bht • phenoxyethanol • mica <iln38907>
- Other information
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton
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INGREDIENTS AND APPEARANCE
ADVANCED TIME ZONE AGE REVERSING LINE WRINKLE BROAD SPECTRUM SPF 15 DRY SKIN
avobenzone, octisalate, and octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11559-020 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 mL in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 mL in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 2.7 mL in 100 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) dimethicone (UNII: 92RU3N3Y1O) shea butter (UNII: K49155WL9Y) butylene glycol (UNII: 3XUS85K0RA) di-c12-15 alkyl fumarate (UNII: A1CB3Z898P) steareth-21 (UNII: 53J3F32P58) pentaerythrityl tetraethylhexanoate (UNII: XJ7052W897) sucrose (UNII: C151H8M554) cetyl alcohol (UNII: 936JST6JCN) glycerin (UNII: PDC6A3C0OX) neopentyl glycol diethylhexanoate (UNII: U68ZV6W62C) steareth-2 (UNII: V56DFE46J5) high density polyethylene (UNII: UG00KM4WR7) watermelon (UNII: 231473QB6R) apple (UNII: B423VGH5S9) lens culinaris fruit (UNII: ZYZ076G9JH) centaurium erythraea (UNII: 57X4TSH58S) laminaria digitata (UNII: 15E7C67EE8) barley (UNII: 5PWM7YLI7R) cucumber (UNII: YY7C30VXJT) tamarind seed (UNII: 6AHP8A7OML) salicornia europaea (UNII: 6ADL50JAKW) polygonum cuspidatum root (UNII: 7TRV45YZF7) vitis vinifera seed (UNII: C34U15ICXA) rosemary (UNII: IJ67X351P9) selaginella tamariscina (UNII: GP370KXK6M) hops (UNII: 01G73H6H83) tangerine peel (UNII: JU3D414057) yeast (UNII: 3NY3SM6B8U) limonium vulgare flowering top (UNII: 840Y01ZC0M) pomegranate juice (UNII: 99S671U9KB) cholesterol (UNII: 97C5T2UQ7J) linoleic acid (UNII: 9KJL21T0QJ) caffeine (UNII: 3G6A5W338E) n-acetylglucosamine (UNII: V956696549) linolenic acid (UNII: 0RBV727H71) adenosine phosphate (UNII: 415SHH325A) acetyl hexapeptide-8 (UNII: L4EL31FWIL) glucose oxidase (UNII: 0T8392U5N1) .alpha.-tocopherol acetate (UNII: 9E8X80D2L0) glyceryl trioleate (UNII: O05EC62663) phytantriol (UNII: 8LVI07A72W) trehalose (UNII: B8WCK70T7I) ppg-15 stearyl ether (UNII: 1II18XLS1L) isohexadecane (UNII: 918X1OUF1E) medium-chain triglycerides (UNII: C9H2L21V7U) ethylhexylglycerin (UNII: 147D247K3P) caprylyl glycol (UNII: 00YIU5438U) helianthus annuus seedcake (UNII: 482WYF7XLC) propylene glycol dicaprate (UNII: U783H9JHWY) propylene glycol heptanoate (UNII: 25DEK56Z7Z) sodium pyrrolidone carboxylate (UNII: 469OTG57A2) dextrose (UNII: IY9XDZ35W2) neopentyl glycol diisostearate (UNII: 4M6OQ34JWW) hyaluronate sodium (UNII: YSE9PPT4TH) sodium lactate (UNII: TU7HW0W0QT) oleic acid (UNII: 2UMI9U37CP) palmitic acid (UNII: 2V16EO95H1) stearic acid (UNII: 4ELV7Z65AP) potassium sulfate (UNII: 1K573LC5TV) decarboxy carnosine hydrochloride (UNII: 6X7K9I5QR7) masoprocol (UNII: 7BO8G1BYQU) tromethamine (UNII: 023C2WHX2V) hexylene glycol (UNII: KEH0A3F75J) silicon dioxide (UNII: ETJ7Z6XBU4) edetate disodium (UNII: 7FLD91C86K) butylated hydroxytoluene (UNII: 1P9D0Z171K) phenoxyethanol (UNII: HIE492ZZ3T) mica (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11559-020-01 1 in 1 CARTON 1 50 mL in 1 CONTAINER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 06/01/2012 Labeler - ESTEE LAUDER INC (005914387) Establishment Name Address ID/FEI Business Operations ELGC K.K. 712808195 RELABEL(11559-020) , REPACK(11559-020) Establishment Name Address ID/FEI Business Operations Estee Lauder Pennsylvania Distribution Center 2 (PADC 2) 828534516 MANUFACTURE(11559-020) , RELABEL(11559-020) , REPACK(11559-020) Establishment Name Address ID/FEI Business Operations Estee Lauder Inc. 042918826 MANUFACTURE(11559-020) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS DISTRIBUTION CENTER 208579636 REPACK(11559-020) , RELABEL(11559-020) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 253616536 MANUFACTURE(11559-020) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 244669714 MANUFACTURE(11559-020) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD. 205952385 MANUFACTURE(11559-020) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER N.V. 370151326 MANUFACTURE(11559-020) Establishment Name Address ID/FEI Business Operations LEN-RON MANUFACTURING DIVISION OF ARAMIS INC 809771152 MANUFACTURE(11559-020) Establishment Name Address ID/FEI Business Operations NORTEC KEYSTONE 943871157 MANUFACTURE(11559-020) , RELABEL(11559-020) , REPACK(11559-020) Establishment Name Address ID/FEI Business Operations NORTHTEC BRISTOL 959338336 MANUFACTURE(11559-020) , RELABEL(11559-020) , REPACK(11559-020) Establishment Name Address ID/FEI Business Operations NORTHTEC KEYSTONE 949264774 MANUFACTURE(11559-020) , RELABEL(11559-020) , REPACK(11559-020) Establishment Name Address ID/FEI Business Operations WHITMAN LABORATORIES, LTD. 216866277 MANUFACTURE(11559-020) Establishment Name Address ID/FEI Business Operations Aveda Corporation 071352058 MANUFACTURE(11559-020) Establishment Name Address ID/FEI Business Operations Pennsylvania Logistics Center 078364654 REPACK(11559-020) , RELABEL(11559-020)
