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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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FLAWLESS SKIN MAKEUP BROAD SPECTRUM SPF 15

Drug Facts

Active Ingredients

Octinoxate 4.10%
Titanium Dioxide 1.40%
Zinc Oxide 1.50%

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

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

Principal Display Panel - 30 ml Bottle Carton
FLAWLESS SKIN MAKEUP BROAD SPECTRUM SPF 15 
octinoxate, titanium dioxide, and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59158-760
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.04551 g  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.01554 g  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.01665 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59158-760-011 in 1 CARTON12/22/2004
130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35212/22/200411/10/2020
Labeler - PRESCRIPTIVES INC. (151701588)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COMPANY, THE828534516RELABEL(59158-760) , REPACK(59158-760)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD244669714MANUFACTURE(59158-760)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD.202952982MANUFACTURE(59158-760)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder N.V.370151326MANUFACTURE(59158-760)
Establishment
NameAddressID/FEIBusiness Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(59158-760)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC INC943871157RELABEL(59158-760) , REPACK(59158-760)
Establishment
NameAddressID/FEIBusiness Operations
PADC 1949264774RELABEL(59158-760) , REPACK(59158-760)
Establishment
NameAddressID/FEIBusiness Operations
WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(59158-760)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD255175580MANUFACTURE(59158-760)

Revised: 12/2018
 
PRESCRIPTIVES INC.