PRESCRIPTIVES SITE UNSEEN BRIGHTENING CONCEALER BROAD SPECTRUM SPF 15- octinoxate, titanium dioxide, and zinc oxide liquid

PRESCRIPTIVES by

Drug Labeling and Warnings

PRESCRIPTIVES by is a Otc medication manufactured, distributed, or labeled by PRESCRIPTIVES 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 ingredients

Octinoxate 4.10%
Titanium Dioxide 1.40%
Zinc Oxide 1.50%

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 dimethicone phenyl trimethicone dimethicone silylate butylene glycol peg/ppg-18/18 dimethicone silica yeast extract\faex\extrait de levure ethylhexylglycerin octyldodecyl neopentanoate tocopheryl acetate triethoxycaprylylsilane glycerin polysilicone-11 magnesium sulfate disteardimonium hectorite dipeptide-2 palmitoyl tetrapeptide-7 sorbitan sesquioleate acetyl hexapeptide-8 polyglyceryl-6 polyricinoleate laureth-7 isopropyl titanium triisostearate propylene carbonate chamomilla recutita (matricaria) hesperidin methyl chalcone steareth-20 alumina chloroxylenol phenoxyethanol [+/- titanium dioxide (ci 77891) mica iron oxides (ci 77491, ci 77492, ci 77499)] <iln32488>

Other information

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

SPL UNCLASSIFIED SECTION

DIST. NEW YORK, N.Y. 10022

PRINCIPAL DISPLAY PANEL - 3.5 ml Carton

PRESCRIPTIVES
Site Unseen
Brightening Concealer Broad Spectrum SPF 15
0.12 FL. OZ./OZ. LIQ./3.5 ml

INGREDIENTS AND APPEARANCE

PRESCRIPTIVES   SITE UNSEEN BRIGHTENING CONCEALER BROAD SPECTRUM SPF 15
octinoxate, titanium dioxide, and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59158-913
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	.04551 g  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	.01554 g  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.01665 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
YEAST (UNII: 3NY3SM6B8U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
GLYCERIN (UNII: PDC6A3C0OX)
MAGNESIUM SULFATE (UNII: DE08037SAB)
VALYLTRYPTOPHAN (UNII: 3G64B4AFQN)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)
LAURETH-7 (UNII: Z95S6G8201)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ)
HESPERIDIN METHYLCHALCONE (UNII: 4T2GVA922X)
STEARETH-20 (UNII: L0Q8IK9E08)
ALUMINUM OXIDE (UNII: LMI26O6933)
CHLOROXYLENOL (UNII: 0F32U78V2Q)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59158-913-01	1 in 1 CARTON
1		3.5 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	11/16/2006

Labeler - PRESCRIPTIVES INC. (151701588)

Establishment
Name	Address	ID/FEI	Business Operations
ELGC K.K.		712808195	RELABEL(59158-913) , REPACK(59158-913)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)		828534516	MANUFACTURE(59158-913) , RELABEL(59158-913) , REPACK(59158-913)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Inc.		042918826	MANUFACTURE(59158-913)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER		208579636	REPACK(59158-913) , RELABEL(59158-913)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		253616536	MANUFACTURE(59158-913)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(59158-913)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		205952385	MANUFACTURE(59158-913)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(59158-913)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(59158-913)

Establishment
Name	Address	ID/FEI	Business Operations
NORTEC KEYSTONE		943871157	MANUFACTURE(59158-913) , RELABEL(59158-913) , REPACK(59158-913)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC BRISTOL		959338336	MANUFACTURE(59158-913) , RELABEL(59158-913) , REPACK(59158-913)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC KEYSTONE		949264774	MANUFACTURE(59158-913) , RELABEL(59158-913) , REPACK(59158-913)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(59158-913)

Establishment
Name	Address	ID/FEI	Business Operations
Aveda Corporation		071352058	MANUFACTURE(59158-913)

Establishment
Name	Address	ID/FEI	Business Operations
Pennsylvania Logistics Center		078364654	REPACK(59158-913) , RELABEL(59158-913)