CYBERWHITE HD UV PROTECTOR BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion 
ESTEE LAUDER 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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CYBERWHITE HD UV PROTECTOR BROAD SPECTRUM SPF 50

Drug Facts

Active ingredientsPurpose
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:

Inactive ingredients

water\aqua\eau • butyloctyl salicylate • methyl trimethicone • neopentyl glycol diheptanoate • aleurites moluccana (kukui) seed oil • lauryl peg-9 polydimethylsiloxyethyl dimethicone • peg-100 stearate • butylene glycol • glyceryl stearate • dipentaerythrityl tri-polyhydroxystearate • potassium cetyl phosphate • scutellaria baicalensis root extract • cucumis sativus (cucumber) fruit extract • hordeum vulgare (barley) extract\extrait d'orge • whey protein\lactis protein\proteine du petit-lait • glycyrrhiza glabra (licorice) root extract • laminaria ochroleuca extract • algae extract • caffeine • sorbitol • oryzanol • yeast extract\faex\extrait de levure • helianthus annuus (sunflower) seedcake • cetyl alcohol • stearic acid • vp/eicosene copolymer • ethylhexylglycerin • saccharide isomerate • propylene glycol dicaprate • tetrahexyldecyl ascorbate • caprylic/capric triglyceride • caprylyl glycol • tocopheryl acetate • ammonium acryloyldimethyltaurate/vp copolymer • sodium hyaluronate • dehydroxanthan gum • sodium dehydroacetate • fragrance (parfum) • citric acid • sodium hydroxide • silica • disodium edta • phenoxyethanol • titanium dioxide (ci 77891) • mica [iln39967]

Other information

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

PRINCIPAL DISPLAY PANEL - 30ml Bottle Carton

ESTĒE LAUDER

CyberWhite HD

UV
Protector

Advanced Brightening
Broad Spectrum
SPF 50

1 FL. OZ. LIQ./30ml e

Principal Display Panel - 30ml Bottle Carton
CYBERWHITE HD UV PROTECTOR BROAD SPECTRUM SPF 50 
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11559-037
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone0.0309 g  in 100 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate0.0515 g  in 100 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate0.0515 g  in 100 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene0.0278 g  in 100 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.0309 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
butyloctyl salicylate (UNII: 2EH13UN8D3)  
methyl trimethicone (UNII: S73ZQI0GXM)  
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)  
glyceryl monostearate (UNII: 230OU9XXE4)  
potassium cetyl phosphate (UNII: 03KCY6P7UT)  
scutellaria baicalensis root (UNII: 7J95K7ID2S)  
cucumber (UNII: YY7C30VXJT)  
whey (UNII: 8617Z5FMF6)  
glycyrrhiza glabra (UNII: 2788Z9758H)  
laminaria ochroleuca (UNII: 4R2124HE76)  
caffeine (UNII: 3G6A5W338E)  
sorbitol (UNII: 506T60A25R)  
gamma oryzanol (UNII: SST9XCL51M)  
yeast (UNII: 3NY3SM6B8U)  
helianthus annuus seedcake (UNII: 482WYF7XLC)  
cetyl alcohol (UNII: 936JST6JCN)  
stearic acid (UNII: 4ELV7Z65AP)  
ethylhexylglycerin (UNII: 147D247K3P)  
saccharide isomerate (UNII: W8K377W98I)  
propylene glycol dicaprate (UNII: U783H9JHWY)  
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)  
medium-chain triglycerides (UNII: C9H2L21V7U)  
caprylyl glycol (UNII: 00YIU5438U)  
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
ammonium acryloyldimethyltaurate/vp copolymer (UNII: W59H9296ZG)  
hyaluronate sodium (UNII: YSE9PPT4TH)  
sodium dehydroacetate (UNII: 8W46YN971G)  
citric acid monohydrate (UNII: 2968PHW8QP)  
sodium hydroxide (UNII: 55X04QC32I)  
silicon dioxide (UNII: ETJ7Z6XBU4)  
edetate disodium (UNII: 7FLD91C86K)  
phenoxyethanol (UNII: HIE492ZZ3T)  
titanium dioxide (UNII: 15FIX9V2JP)  
mica (UNII: V8A1AW0880)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11559-037-011 in 1 CARTON
130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35210/01/2013
Labeler - ESTEE LAUDER INC (005914387)
Establishment
NameAddressID/FEIBusiness Operations
ELGC K.K.712808195RELABEL(11559-037) , REPACK(11559-037)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)828534516MANUFACTURE(11559-037) , RELABEL(11559-037) , REPACK(11559-037)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD244669714MANUFACTURE(11559-037)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD.205952385MANUFACTURE(11559-037)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER N.V.370151326MANUFACTURE(11559-037)
Establishment
NameAddressID/FEIBusiness Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(11559-037)
Establishment
NameAddressID/FEIBusiness Operations
NORTEC KEYSTONE943871157MANUFACTURE(11559-037) , RELABEL(11559-037) , REPACK(11559-037)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC BRISTOL959338336MANUFACTURE(11559-037) , RELABEL(11559-037) , REPACK(11559-037)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC KEYSTONE949264774MANUFACTURE(11559-037) , RELABEL(11559-037) , REPACK(11559-037)
Establishment
NameAddressID/FEIBusiness Operations
WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(11559-037)
Establishment
NameAddressID/FEIBusiness Operations
Aveda Corporation071352058MANUFACTURE(11559-037)
Establishment
NameAddressID/FEIBusiness Operations
Pennsylvania Logistics Center078364654REPACK(11559-037) , RELABEL(11559-037)

Revised: 10/2013
Document Id: 92fd4bbc-9326-4d73-af81-82a37cdd3b73
Set id: 55929d6e-4576-4952-8e19-72694d2da092
Version: 1
Effective Time: 20131029
 
ESTEE LAUDER INC