RE-NUTRIV ULTRA RADIANCE MAKEUP BROAD SPECTRUM SPF 20- octinoxate and titanium dioxide liquid

RE-NUTRIV ULTRA RADIANCE MAKEUP BROAD SPECTRUM SPF 20 by

Drug Labeling and Warnings

RE-NUTRIV ULTRA RADIANCE MAKEUP BROAD SPECTRUM SPF 20 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
Octinoxate 2.2%	Sunscreen
Titanium Dioxide 1.4%	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 phenyl trimethicone methyl trimethicone dimethicone butylene glycol isocetyl alcohol peg/ppg-18/18 dimethicone rhodochrosite extract caprylic/capric triglyceride isohexadecane sorbitan sesquioleate magnesium sulfate wheat germ glycerides tribehenin olivine extract laminaria digitata extract sodium hyaluronate trifluoroacetyl tripeptide-2 palmitoyl tripeptide-1 pearl powder gold ruby powder sapphire powder nephrite powder citrullus vulgaris (watermelon) fruit extract pyrus malus (apple) fruit extract lens esculenta (lentil) fruit extract algae extract oryza sativa (rice) bran extract gentiana lutea (gentian) root extract ascorbyl palmitate ergothioneine simmondsia chinensis (jojoba) seed oil tocopheryl acetate hydrolyzed wheat protein linoleic acid laureth-7 triethyl citrate stearic acid ethylhexylglycerin polymethylsilsesquioxane cholesterol hydrogenated lecithin glycerin ethylhexyl palmitate propylene carbonate polyphenylsilsesquioxane polysilicone-11 sodium lactate triethoxycaprylylsilane tocopherol sodium pca sorbitan isostearate sorbitan stearate magnesium ascorbyl phosphate aluminum hydroxide methicone xanthan gum cetyl peg/ppg-10/1 dimethicone lauryl peg-9 polydimethylsiloxyethyl dimethicone disteardimonium hectorite dextran boron nitride sodium metabisulfite fragrance (parfum) bht pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate sorbic acid sodium benzoate potassium sorbate chloroxylenol phenoxyethanol [+/- mica titanium dioxide (ci 77891) iron oxides (ci 77492) iron oxides (ci 77491) iron oxides (ci 77499)] <iln46282>

Other information

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

PRINCIPAL DISPLAY PANEL - 30 ml Tube Carton

Re-Nutriv
ESTĒE LAUDER

Ultra Radiance
Liquid Makeup

Broad Spectrum

SPF 20

1 FL. OZ. LIQ.
30 ml e

INGREDIENTS AND APPEARANCE

RE-NUTRIV ULTRA RADIANCE MAKEUP BROAD SPECTRUM SPF 20 
octinoxate and titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11559-057
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.024 g  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.015 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ISOCETYL ALCOHOL (UNII: 1800H64066)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ISOHEXADECANE (UNII: 918X1OUF1E)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
WHEAT GERM OIL (UNII: 14C97E680P)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
LAMINARIA DIGITATA (UNII: 15E7C67EE8)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
PEARL (HYRIOPSIS CUMINGII) (UNII: A75L5FZ40U)
GOLD (UNII: 79Y1949PYO)
WATERMELON (UNII: 231473QB6R)
APPLE (UNII: B423VGH5S9)
LENS CULINARIS FRUIT (UNII: ZYZ076G9JH)
RICE BRAN (UNII: R60QEP13IC)
GENTIANA LUTEA ROOT (UNII: S72O3284MS)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
ERGOTHIONEINE (UNII: BDZ3DQM98W)
JOJOBA OIL (UNII: 724GKU717M)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HYDROLYZED WHEAT PROTEIN (ENZYMATIC; 3000 MW) (UNII: J2S07SB0YL)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
LAURETH-7 (UNII: Z95S6G8201)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
STEARIC ACID (UNII: 4ELV7Z65AP)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
CHOLESTEROL (UNII: 97C5T2UQ7J)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
GLYCERIN (UNII: PDC6A3C0OX)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SODIUM LACTATE (UNII: TU7HW0W0QT)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
TOCOPHEROL (UNII: R0ZB2556P8)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
METHICONE (20 CST) (UNII: 6777U11MKT)
XANTHAN GUM (UNII: TTV12P4NEE)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BORON NITRIDE (UNII: 2U4T60A6YD)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
SORBIC ACID (UNII: X045WJ989B)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CHLOROXYLENOL (UNII: 0F32U78V2Q)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11559-057-01	1 in 1 CARTON	07/15/2019
1		30 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	07/15/2019

Labeler - ESTEE LAUDER INC (005914387)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(11559-057) , REPACK(11559-057)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(11559-057)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(11559-057)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(11559-057)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(11559-057)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(11559-057) , REPACK(11559-057)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(11559-057) , REPACK(11559-057)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(11559-057)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(11559-057)