FLAWLESS SKIN MAKEUP BROAD SPECTRUM SPF 15- octinoxate, titanium dioxide, and zinc oxide liquid

FLAWLESS SKIN MAKEUP BROAD SPECTRUM SPF 15 by

Drug Labeling and Warnings

FLAWLESS SKIN MAKEUP BROAD SPECTRUM SPF 15 by is a Otc medication manufactured, distributed, or labeled by PRESCRIPTIVES 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]

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 ■ phenyl trimethicone ■ dimethicone ■ dimethicone silylate ■ butylene glycol ■ peg/ppg-18/18 dimethicone ■ silica ■ micrococcus lysate ■ polygonum cuspidatum root extract ■ quaternium-90 bentonite ■ ethylhexylglycerin ■ rosmarinus officinalis (rosemary) extract ■ octyldodecyl neopentanoate ■ tocopheryl acetate ■ triethoxycaprylylsilane ■ polysilicone-11 ■ magnesium sulfate ■ disteardimonium hectorite ■ lecithin ■ polyglyceryl-6 polyricinoleate ■ trifluoromethyl c1-4 alkyl dimethicone ■ laureth-7 ■ isopropyl titanium triisostearate ■ propylene carbonate ■ chamomilla recutita (matricaria) ■ alumina ■ chloroxylenol ■ phenoxyethanol ■ [+/- titanium dioxide (ci 77891) ■ mica ■ iron oxides (ci 77491, ci 77492, ci 77499)] <iln33886>

Other information

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

SPL UNCLASSIFIED SECTION

PRESCRIPTIVES CO., DIST.,
NEW YORK, N.Y. 10022

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

PRESCRIPTIVES

Flawless Skin

Makeup

Broad Spectrum SPF 15

1 FL. OZ./OZ. LIQ./30 ml e

INGREDIENTS AND APPEARANCE

FLAWLESS SKIN MAKEUP BROAD SPECTRUM SPF 15 
octinoxate, titanium dioxide, and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59158-760
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.04551 g  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.01554 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)
phenyl trimethicone (UNII: DR0K5NOJ4R)
dimethicone (UNII: 92RU3N3Y1O)
butylene glycol (UNII: 3XUS85K0RA)
peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)
silicon dioxide (UNII: ETJ7Z6XBU4)
reynoutria japonica root (UNII: 7TRV45YZF7)
ethylhexylglycerin (UNII: 147D247K3P)
rosemary (UNII: IJ67X351P9)
octyldodecyl neopentanoate (UNII: X8725R883T)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
triethoxycaprylylsilane (UNII: LDC331P08E)
magnesium sulfate, unspecified form (UNII: DE08037SAB)
laureth-7 (UNII: Z95S6G8201)
isopropyl titanium triisostearate (UNII: 949E3KBJ1I)
propylene carbonate (UNII: 8D08K3S51E)
matricaria chamomilla (UNII: G0R4UBI2ZZ)
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: 59158-760-01	1 in 1 CARTON	12/22/2004
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	12/22/2004

Labeler - PRESCRIPTIVES INC. (151701588)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(59158-760) , REPACK(59158-760)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(59158-760)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(59158-760)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(59158-760)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(59158-760)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(59158-760) , REPACK(59158-760)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(59158-760) , REPACK(59158-760)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(59158-760)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(59158-760)