RE-NUTRIV ULTIMATE LIFTING MAKEUP SPF15- titanium dioxide cream

RE-NUTRIV by

Drug Labeling and Warnings

RE-NUTRIV by is a Otc medication manufactured, distributed, or labeled by ESTEE LAUDER INC, ELGC K.K., Estee Lauder Pennsylvania Distribution Center 2 (PADC 2), Estee Lauder Inc., ESTEE LAUDER COSMETICS DISTRIBUTION CENTER, ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER COSMETICS, LTD., ESTEE LAUDER N.V., LEN-RON MANUFACTURING DIVISION OF ARAMIS INC, NORTEC KEYSTONE, NORTHTEC BRISTOL, NORTHTEC KEYSTONE, WHITMAN LABORATORIES, LTD., Aveda Corporation, Pennsylvania Logistics Center. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Titanium Dioxide 1.40%

Purpose

Sunscreen

Use

helps prevent sunburn

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 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 cyclopentasiloxane butylene glycol phenyl trimethicone cetyl dimethicone dimethicone pentaerythrityl tetraethylhexanoate octyldodecyl stearoyl stearate peg/ppg-18/18 dimethicone cetyl peg/ppg-10/1 dimethicone magnesium sulfate ethylhexyl palmitate astrocaryum murumuru butter pyrus malus (apple) fruit extract silybum marianum (lady's thistle) extract acetyl hexapeptide-8 oryza sativa (rice) bran extract pisum sativum (pea) extract aminopropyl ascorbyl phosphate tocopheryl acetate palmitoyl oligopeptide caffeine linoleic acid cholesterol quaternium-90 bentonite acetyl carnitine hcl ascorbyl palmitate disodium nadh ethylhexylglycerin 7-dehydrocholesterol trimethylsiloxysilicate tribehenin phytosteryl/octyldodecyl lauroyl glutamate methicone zinc stearate sorbitan isostearate laureth-7 sucrose trifluoromethyl c1-4 alkyl dimethicone glyceryl polymethacrylate hydrolyzed fish (pisces) collagen propylene carbonate caprylyl glycol sodium hyaluronate peg-8 hydrogenated lecithin xanthan gum alumina fragrance (parfum) sodium chloride bht chloroxylenol phenoxyethanol [+/- iron oxides (ci 77491, ci 77492, ci 77499) titanium dioxide (ci 77891) mica] <iln37196>

Other information

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

PRINCIPAL DISPLAY PANEL - 30 ml Container Carton

ESTĒE LAUDER
Re-Nutriv

Ultimate Lifting Creme Makeup
Broad Spectrum SPF 15

INGREDIENTS AND APPEARANCE

RE-NUTRIV   ULTIMATE LIFTING MAKEUP SPF15
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11559-724
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.4 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
cyclomethicone 5 (UNII: 0THT5PCI0R)
butylene glycol (UNII: 3XUS85K0RA)
phenyl trimethicone (UNII: DR0K5NOJ4R)
dimethicone (UNII: 92RU3N3Y1O)
pentaerythrityl tetraethylhexanoate (UNII: XJ7052W897)
octyldodecyl stearoyl stearate (UNII: 3D47Q6D93C)
peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)
magnesium sulfate (UNII: DE08037SAB)
ethylhexyl palmitate (UNII: 2865993309)
astrocaryum murumuru seed butter (UNII: 12V64UPU6R)
apple (UNII: B423VGH5S9)
milk thistle (UNII: 822I9LEJ7S)
acetyl hexapeptide-8 (UNII: L4EL31FWIL)
rice bran (UNII: R60QEP13IC)
pea (UNII: W4X7H8GYFM)
aminopropyl ascorbyl phosphate (UNII: 290O2PQ83R)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
palmitoyl oligopeptide (UNII: HO4ZT5S86C)
caffeine (UNII: 3G6A5W338E)
linoleic acid (UNII: 9KJL21T0QJ)
cholesterol (UNII: 97C5T2UQ7J)
acetylcarnitine hydrochloride (UNII: NDW10MX58T)
ascorbyl palmitate (UNII: QN83US2B0N)
ethylhexylglycerin (UNII: 147D247K3P)
7-dehydrocholesterol (UNII: BK1IU07GKF)
tribehenin (UNII: 8OC9U7TQZ0)
zinc stearate (UNII: H92E6QA4FV)
sorbitan isostearate (UNII: 01S2G2C1E4)
laureth-7 (UNII: Z95S6G8201)
sucrose (UNII: C151H8M554)
propylene carbonate (UNII: 8D08K3S51E)
caprylyl glycol (UNII: 00YIU5438U)
hyaluronate sodium (UNII: YSE9PPT4TH)
polyethylene glycol 400 (UNII: B697894SGQ)
hydrogenated soybean lecithin (UNII: H1109Z9J4N)
xanthan gum (UNII: TTV12P4NEE)
aluminum oxide (UNII: LMI26O6933)
sodium chloride (UNII: 451W47IQ8X)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
chloroxylenol (UNII: 0F32U78V2Q)
phenoxyethanol (UNII: HIE492ZZ3T)
ferric oxide red (UNII: 1K09F3G675)
ferric oxide yellow (UNII: EX438O2MRT)
ferrosoferric oxide (UNII: XM0M87F357)
mica (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11559-724-01	1 in 1 CARTON
1		30 mL in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	01/01/2005

Labeler - ESTEE LAUDER INC (005914387)

Establishment
Name	Address	ID/FEI	Business Operations
ELGC K.K.		712808195	RELABEL(11559-724) , REPACK(11559-724)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)		828534516	MANUFACTURE(11559-724) , RELABEL(11559-724) , REPACK(11559-724)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Inc.		042918826	MANUFACTURE(11559-724)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER		208579636	REPACK(11559-724) , RELABEL(11559-724)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		253616536	MANUFACTURE(11559-724)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(11559-724)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		205952385	MANUFACTURE(11559-724)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(11559-724)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(11559-724)

Establishment
Name	Address	ID/FEI	Business Operations
NORTEC KEYSTONE		943871157	MANUFACTURE(11559-724) , RELABEL(11559-724) , REPACK(11559-724)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC BRISTOL		959338336	MANUFACTURE(11559-724) , RELABEL(11559-724) , REPACK(11559-724)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC KEYSTONE		949264774	MANUFACTURE(11559-724) , RELABEL(11559-724) , REPACK(11559-724)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(11559-724)

Establishment
Name	Address	ID/FEI	Business Operations
Aveda Corporation		071352058	MANUFACTURE(11559-724)

Establishment
Name	Address	ID/FEI	Business Operations
Pennsylvania Logistics Center		078364654	REPACK(11559-724) , RELABEL(11559-724)