REVITALIZING SUPREME PLUS GLOBAL ANTI-AGING CELL POWER CREME BROAD SPECTRUM SPF 15- avobenzone, octisalate, and octocrylene cream

REVITALIZING SUPREME PLUS GLOBAL ANTI-AGING CELL POWER CREME BROAD SPECTRUM SPF 15 by

Drug Labeling and Warnings

REVITALIZING SUPREME PLUS GLOBAL ANTI-AGING CELL POWER CREME BROAD SPECTRUM SPF 15 by is a Otc medication manufactured, distributed, or labeled by ESTEE LAUDER INC, Estee Lauder Companies Inc., PALC, Estee Lauder Cosmetics Ltd., Whitman Laboratories Ltd., Estee Lauder N.V., The Estee Lauder Inc, Northtec LLC, PADC 1. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Avobenzone 3.0%	Sunscreen
Octisalate 4.5%	Sunscreen
Octocrylene 5.0%	Sunscreen

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

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

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 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

protect the product in this container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton

ESTĒE LAUDER

Revitalizing Supreme +
Global Anti-Aging Cell Power Creme
Broad Spectrum SPF 15

All Skintypes

POIDS NET WT. 1.7 OZ./50 ml e

INGREDIENTS AND APPEARANCE

REVITALIZING SUPREME PLUS GLOBAL ANTI-AGING CELL POWER CREME BROAD SPECTRUM SPF 15 
avobenzone, octisalate, and octocrylene cream

Product 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	0.031 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.047 g  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.052 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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)
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)

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	05/01/2019

Labeler - ESTEE LAUDER INC (005914387)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(11559-056) , REPACK(11559-056)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(11559-056)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(11559-056)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(11559-056)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(11559-056)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(11559-056) , REPACK(11559-056)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(11559-056) , REPACK(11559-056)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(11559-056)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(11559-056)