BRIGHTER BY NATURE SPF 30 CORRECTING MAKEUP BROAD SPECTRUM- octinoxate, octocrylene, and titanium dioxide powder

BRIGHTER BY NATURE SPF 30 CORRECTING MAKEUP BROAD SPECTRUM by

Drug Labeling and Warnings

BRIGHTER BY NATURE SPF 30 CORRECTING MAKEUP BROAD SPECTRUM by is a Otc medication manufactured, distributed, or labeled by ORIGINS NATURAL RESOURCES 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., JO COSMETICS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
octinoxate 7.50%	Sunscreen
octocrylene 1.00%	Sunscreen
titanium dioxide 3.00%	Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun

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 generously and evenly 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 10am – 2pm
  • wear long-sleeved shirts, pants, hats and sunglasses
• children under 6 months of age: ask a doctor

Inactive ingredients

mica lauroyl lysine cellulose acetate dimethicone ascorbyl palmitate rosmarinus officinalis (rosemary) extract punica granatum (pomegranate) juice extract sanguisorba officinalis (burnet) root extract curcuma longa (turmeric) root extract caprylyl methicone methicone ethylhexylglycerin caffeine oryzanol isostearyl sebacate disodium stearoyl glutamate pentylene glycol zinc myristate silica glycyrrhetinic acid alumina citrus aurantifolia (lime) oil1, citrus grandis (grapefruit) peel oil1, cymbopogon schoenanthus (lemongrass) oil1, mentha viridis (spearmint) leaf oil1, salvia sclarea (clary sage) oil1, ormenis multicaulis (chamomile) oil1, pelargonium graveolens (geranium) flower oil1, lavandula angustifolia (lavender) oil1, thymus vulgaris (thyme) oil1, coriandrum sativum (coriander) fruit oil1, limonene, linalool phenoxyethanol [+/- iron oxides (ci 77491, ci 77492, ci 77499) titanium dioxide (ci 77891)] <iln37037>

1 essential oil

Other information

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

PRINCIPAL DISPLAY PANEL - 8 g Container Carton

ORIGINS

Brighter By Nature™ SPF 30
Skin tone correcting makeup

Broad Spectrum SPF 30
net wt./poids net .28 oz./8 g e

INGREDIENTS AND APPEARANCE

BRIGHTER BY NATURE SPF 30 CORRECTING MAKEUP BROAD SPECTRUM 
octinoxate, octocrylene, and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59427-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
mica (UNII: V8A1AW0880)
lauroyl lysine (UNII: 113171Q70B)
cellulose acetate (UNII: 3J2P07GVB6)
dimethicone (UNII: 92RU3N3Y1O)
ascorbyl palmitate (UNII: QN83US2B0N)
rosemary (UNII: IJ67X351P9)
pomegranate juice (UNII: 99S671U9KB)
sanguisorba officinalis root (UNII: 4NYV2HT01X)
turmeric (UNII: 856YO1Z64F)
caprylyl trisiloxane (UNII: Q95M2P1KJL)
ethylhexylglycerin (UNII: 147D247K3P)
caffeine (UNII: 3G6A5W338E)
gamma oryzanol (UNII: SST9XCL51M)
disodium stearoyl glutamate (UNII: 45ASM2L11M)
pentylene glycol (UNII: 50C1307PZG)
zinc myristate (UNII: K09A9E2GGO)
silicon dioxide (UNII: ETJ7Z6XBU4)
enoxolone (UNII: P540XA09DR)
aluminum oxide (UNII: LMI26O6933)
lime oil (UNII: UZH29XGA8G)
citrus maxima fruit rind oil (UNII: 8U3877WD44)
cymbopogon schoenanthus oil (UNII: XE7K568ILO)
spearmint oil (UNII: C3M81465G5)
clary sage oil (UNII: 87L0D4U3M0)
pelargonium graveolens flower oil (UNII: 3K0J1S7QGC)
lavender oil (UNII: ZBP1YXW0H8)
thyme oil (UNII: 2UK410MY6B)
coriander oil (UNII: 7626GC95E5)
linalool, (+/-)- (UNII: D81QY6I88E)
phenoxyethanol (UNII: HIE492ZZ3T)
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: 59427-009-01	1 in 1 CARTON	11/01/2010
1		8 g in 1 CONTAINER; 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	11/01/2010

Labeler - ORIGINS NATURAL RESOURCES INC. (611716283)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(59427-009) , REPACK(59427-009)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(59427-009)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(59427-009)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(59427-009)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(59427-009)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(59427-009) , REPACK(59427-009)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(59427-009) , REPACK(59427-009)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(59427-009)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(59427-009)

Establishment
Name	Address	ID/FEI	Business Operations
JO COSMETICS		691485222	MANUFACTURE(59427-009)