Label: REVITALIZING SUPREME PLUS GLOBAL ANTI-AGING CELL POWER CREME BROAD SPECTRUM SPF 15- avobenzone, octisalate, and octocrylene cream
- NDC Code(s): 11559-056-01, 11559-056-02
- Packager: ESTEE LAUDER 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 August 31, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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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
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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 • butyloctyl salicylate • glycerin • polysorbate 60 • cetyl alcohol • sorbitan stearate • dimethicone • tridecyl stearate • butylene glycol • pentylene glycol • moringa oleifera seed extract • opuntia tuna extract • hordeum vulgare (barley) extract\extrait d'orge • cucumis sativus (cucumber) fruit extract • narcissus tazetta bulb extract • sigesbeckia orientalis (st. paul's wort) extract • pyrus malus (apple) fruit extract • lens esculenta (lentil) fruit extract • whey protein\lactis protein\proteine du petit-lait • citrullus vulgaris (watermelon) fruit extract • caffeine • algae extract • laminaria digitata extract • tocopheryl acetate • acetyl glucosamine • astrocaryum murumuru seed butter • sucrose • tridecyl trimellitate • dipentaerythrityl hexacaprylate/hexacaprate • peg-100 stearate • trehalose • helianthus annuus (sunflower) seedcake • cetyl palmitate • sorbitol • sodium lactate • acetyl hexapeptide-8 • acrylates/c10-30 alkyl acrylate crosspolymer • sorbitan palmitate • sorbitan olivate • ethylhexylglycerin • sodium pca • pvp/hexadecene copolymer • sodium polyacrylate • propylene glycol dicaprate • sodium hyaluronate • isoceteth-20 • polyethylene • fragrance (parfum) • tetrahexyldecyl ascorbate • sodium hydroxide • sodium benzoate • disodium edta • bht • phenoxyethanol • chlorphenesin • yellow 5 (ci 19140) • red 4 (ci 14700) <iln44861>
- Other information
- PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton
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INGREDIENTS AND APPEARANCE
REVITALIZING SUPREME PLUS GLOBAL ANTI-AGING CELL POWER CREME BROAD SPECTRUM SPF 15
avobenzone, octisalate, and octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11559-056 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 45 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength N-ACETYLGLUCOSAMINE (UNII: V956696549) ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R) SUCROSE (UNII: C151H8M554) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) PEG-100 STEARATE (UNII: YD01N1999R) TREHALOSE (UNII: B8WCK70T7I) HELIANTHUS ANNUUS SEEDCAKE (UNII: 482WYF7XLC) CETYL PALMITATE (UNII: 5ZA2S6B08X) SORBITOL (UNII: 506T60A25R) SODIUM LACTATE (UNII: TU7HW0W0QT) ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) SORBITAN MONOPALMITATE (UNII: 77K6Z421KU) SORBITAN OLIVATE (UNII: MDL271E3GR) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) PROPYLENE GLYCOL DICAPRATE (UNII: U783H9JHWY) HYALURONATE SODIUM (UNII: YSE9PPT4TH) ISOCETETH-20 (UNII: O020065R7Z) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM BENZOATE (UNII: OJ245FE5EU) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) PHENOXYETHANOL (UNII: HIE492ZZ3T) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CHLORPHENESIN (UNII: I670DAL4SZ) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C RED NO. 4 (UNII: X3W0AM1JLX) WATER (UNII: 059QF0KO0R) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) GLYCERIN (UNII: PDC6A3C0OX) POLYSORBATE 60 (UNII: CAL22UVI4M) CETYL ALCOHOL (UNII: 936JST6JCN) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) DIMETHICONE (UNII: 92RU3N3Y1O) TRIDECYL STEARATE (UNII: A8OE252M6L) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PENTYLENE GLYCOL (UNII: 50C1307PZG) MORINGA OLEIFERA LEAF (UNII: 4WET1AWO9B) BARLEY (UNII: 5PWM7YLI7R) CUCUMBER (UNII: YY7C30VXJT) NARCISSUS TAZETTA BULB (UNII: K17762966S) APPLE (UNII: B423VGH5S9) LENS CULINARIS FRUIT (UNII: ZYZ076G9JH) WHEY (UNII: 8617Z5FMF6) WATERMELON (UNII: 231473QB6R) CAFFEINE (UNII: 3G6A5W338E) LAMINARIA DIGITATA (UNII: 15E7C67EE8) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11559-056-01 1 in 1 CARTON 05/01/2019 1 50 mL in 1 JAR; Type 0: Not a Combination Product 2 NDC:11559-056-02 1 in 1 CARTON 12/01/2022 2 75 mL in 1 JAR; 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 05/01/2019 Labeler - ESTEE LAUDER INC (005914387) Registrant - Estee Lauder Companies Inc. (790802086) Establishment Name Address ID/FEI Business Operations PALC 078364654 pack(11559-056) , label(11559-056) Establishment Name Address ID/FEI Business Operations The Estee Lauder Inc 802599436 manufacture(11559-056) , pack(11559-056) , label(11559-056) Establishment Name Address ID/FEI Business Operations Northtec LLC 943871157 pack(11559-056) , label(11559-056) Establishment Name Address ID/FEI Business Operations PADC 1 949264774 pack(11559-056) , label(11559-056)
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