CYBERWHITE HD BB ADVANCED BRIGHTENING BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone cream

CYBERWHITE HD BB ADVANCED BRIGHTENING BROAD SPECTRUM SPF 50 by

Drug Labeling and Warnings

CYBERWHITE HD BB ADVANCED BRIGHTENING BROAD SPECTRUM SPF 50 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
Avobenzone 3.00%	Sunscreen
Homosalate 5.00%	Sunscreen
Octisalate 5.00%	Sunscreen
Octocrylene 2.70%	Sunscreen
Oxybenzone 3.00%	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 butyloctyl salicylate neopentyl glycol diheptanoate aleurites moluccana (kukui) seed oil lauryl peg-9 polydimethylsiloxyethyl dimethicone peg-100 stearate butylene glycol methyl trimethicone glyceryl stearate dipentaerythrityl tri-polyhydroxystearate potassium cetyl phosphate glycyrrhiza glabra (licorice) root extract hordeum vulgare (barley) extract\extrait d'orge algae extract cucumis sativus (cucumber) fruit extract whey protein\lactis protein\proteine du petit-lait scutellaria baicalensis root extract laminaria ochroleuca extract caffeine lecithin yeast extract\faex\extrait de levure oryzanol sorbitol sodium hyaluronate ethylhexylglycerin helianthus annuus (sunflower) seedcake propylene glycol dicaprate cetyl alcohol vp/eicosene copolymer saccharide isomerate caprylic/capric triglyceride caprylyl glycol ammonium acryloyldimethyltaurate/vp copolymer potassium sorbate tocopheryl acetate dehydroxanthan gum stearic acid citric acid tetrahexyldecyl ascorbate silica fragrance (parfum) disodium edta phenoxyethanol [+/-titanium dioxide (ci 77891) iron oxides (ci 77492) iron oxides (ci 77491) iron oxides (ci 77499) mica] <iln40245>

Other information

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

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton

TRAVEL EXCLUSIVE

ESTĒE LAUDER

CyberWhite HD

BB
Creme

Advanced Brightening
Broad Spectrum
SPF 50

1.7 FL. OZ. LIQ./50 ml e

INGREDIENTS AND APPEARANCE

CYBERWHITE HD BB ADVANCED BRIGHTENING BROAD SPECTRUM SPF 50 
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11559-040
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	0.0309 g  in 100 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	0.0515 g  in 100 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	0.0515 g  in 100 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	0.0278 g  in 100 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.0309 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
butyloctyl salicylate (UNII: 2EH13UN8D3)
neopentyl glycol diheptanoate (UNII: 5LKW3C543X)
KUKUI NUT OIL (UNII: TP11QR7B8R)
lauryl peg-9 polydimethylsiloxyethyl dimethicone (UNII: 25G622K2RA)
peg-100 stearate (UNII: YD01N1999R)
butylene glycol (UNII: 3XUS85K0RA)
methyl trimethicone (UNII: S73ZQI0GXM)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
potassium cetyl phosphate (UNII: 03KCY6P7UT)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
BARLEY (UNII: 5PWM7YLI7R)
CUCUMBER (UNII: YY7C30VXJT)
WHEY (UNII: 8617Z5FMF6)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
LAMINARIA OCHROLEUCA (UNII: 4R2124HE76)
caffeine (UNII: 3G6A5W338E)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
GAMMA ORYZANOL (UNII: SST9XCL51M)
sorbitol (UNII: 506T60A25R)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ethylhexylglycerin (UNII: 147D247K3P)
HELIANTHUS ANNUUS SEEDCAKE (UNII: 482WYF7XLC)
propylene glycol dicaprate (UNII: U783H9JHWY)
cetyl alcohol (UNII: 936JST6JCN)
saccharide isomerate (UNII: W8K377W98I)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
caprylyl glycol (UNII: 00YIU5438U)
ammonium acryloyldimethyltaurate/vp copolymer (UNII: W59H9296ZG)
potassium sorbate (UNII: 1VPU26JZZ4)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
stearic acid (UNII: 4ELV7Z65AP)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
phenoxyethanol (UNII: HIE492ZZ3T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
mica (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11559-040-01	1 in 1 CARTON	12/01/2013
1		50 mL in 1 TUBE; 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	12/01/2013

Labeler - ESTEE LAUDER INC (005914387)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(11559-040) , REPACK(11559-040)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(11559-040)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(11559-040)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(11559-040)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(11559-040)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(11559-040) , REPACK(11559-040)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(11559-040) , REPACK(11559-040)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(11559-040)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(11559-040)