PERFECTIONIST YOUTH-INFUSING MAKEUP BROAD SPECTRUM SPF 25- octinoxate and titanium dioxide cream

Perfectionist Youth-Infusing Makeup Broad Spectrum SPF 25 by

Drug Labeling and Warnings

Perfectionist Youth-Infusing Makeup Broad Spectrum SPF 25 by is a Otc medication manufactured, distributed, or labeled by ESTEE LAUDER INC, ESTEE LAUDER COMPANY, THE, ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER COSMETICS, LTD., ESTEE LAUDER N.V., LEN-RON MANUFACTURING DIVISION OF ARAMIS INC, NORTHTEC INC, PADC 1, WHITMAN LABORATORIES, LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Octinoxate 7.50%	Sunscreen
Titanium Dioxide 1.90%	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 isododecane dimethicone butylene glycol phenyl trimethicone polysilicone-11 polymethyl methacrylate coco-caprylate/caprate peg/ppg-18/18 dimethicone silica polyglyceryl-4 isostearate sigesbeckia orientalis (st. paul's wort) extract boswellia serrata extract chlorella vulgaris extract artemia extract hydrolyzed fish (pisces) collagen whey protein\lactis protein\proteine du petit-lait fish (pisces) collagen acetyl hexapeptide-8 palmitoyl oligopeptide cholesterol sodium chondroitin sulfate caffeine glycerin sodium hyaluronate glycine soja (soybean) protein aminopropyl ascorbyl phosphate decarboxy carnosine hcl cetyl peg/ppg-10/1 dimethicone sodium pca disteardimonium hectorite c12-16 alcohols dimethicone silylate caprylyl glycol triethyl citrate palmitic acid hydrogenated lecithin hexyl laurate methicone glyceryl polymethacrylate tetrahexyldecyl ascorbate peg-8 hexylene glycol triethoxycaprylylsilane magnesium aluminum silicate sodium chloride lecithin alumina xanthan gum disodium edta phenoxyethanol [+/- mica titanium dioxide (ci 77891) iron oxides (ci 77492) iron oxides (ci 77499) iron oxides (ci 77491)] <iln40287>

Other information

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

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

ESTĒE LAUDER

Perfectionist
Youth-Infusing
Makeup
Broad Spectrum
SPF 25

1 FL. OZ. LIQ./30 ml e

INGREDIENTS AND APPEARANCE

PERFECTIONIST YOUTH-INFUSING MAKEUP BROAD SPECTRUM SPF 25 
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11559-042
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.0795 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.02014 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
cyclomethicone 5 (UNII: 0THT5PCI0R)
isododecane (UNII: A8289P68Y2)
dimethicone (UNII: 92RU3N3Y1O)
butylene glycol (UNII: 3XUS85K0RA)
phenyl trimethicone (UNII: DR0K5NOJ4R)
coco-caprylate/caprate (UNII: 8D9H4QU99H)
peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)
silicon dioxide (UNII: ETJ7Z6XBU4)
polyglyceryl-4 isostearate (UNII: 820DPX33S7)
indian frankincense (UNII: 4PW41QCO2M)
chlorella vulgaris (UNII: RYQ4R60M02)
whey (UNII: 8617Z5FMF6)
acetyl hexapeptide-8 (UNII: L4EL31FWIL)
PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)
cholesterol (UNII: 97C5T2UQ7J)
caffeine (UNII: 3G6A5W338E)
glycerin (UNII: PDC6A3C0OX)
hyaluronate sodium (UNII: YSE9PPT4TH)
aminopropyl ascorbyl phosphate (UNII: 290O2PQ83R)
decarboxy carnosine hydrochloride (UNII: 6X7K9I5QR7)
sodium pyrrolidone carboxylate (UNII: 469OTG57A2)
disteardimonium hectorite (UNII: X687XDK09L)
c12-16 alcohols (UNII: S4827SZE3L)
caprylyl glycol (UNII: 00YIU5438U)
triethyl citrate (UNII: 8Z96QXD6UM)
palmitic acid (UNII: 2V16EO95H1)
hexyl laurate (UNII: 4CG9F9W01Q)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
polyethylene glycol 400 (UNII: B697894SGQ)
hexylene glycol (UNII: KEH0A3F75J)
triethoxycaprylylsilane (UNII: LDC331P08E)
magnesium aluminum silicate (UNII: 6M3P64V0NC)
sodium chloride (UNII: 451W47IQ8X)
aluminum oxide (UNII: LMI26O6933)
xanthan gum (UNII: TTV12P4NEE)
edetate disodium (UNII: 7FLD91C86K)
phenoxyethanol (UNII: HIE492ZZ3T)
mica (UNII: V8A1AW0880)
ferric oxide yellow (UNII: EX438O2MRT)
ferrosoferric oxide (UNII: XM0M87F357)
ferric oxide red (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11559-042-01	1 in 1 CARTON	05/01/2014
1		30 mL in 1 BOTTLE; 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	05/01/2014

Labeler - ESTEE LAUDER INC (005914387)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(11559-042) , REPACK(11559-042)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(11559-042)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(11559-042)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(11559-042)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(11559-042)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(11559-042) , REPACK(11559-042)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(11559-042) , REPACK(11559-042)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(11559-042)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(11559-042)