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

CYBERWHITE HD UV PROTECTOR BROAD SPECTRUM SPF 50 by

Drug Labeling and Warnings

CYBERWHITE HD UV PROTECTOR BROAD SPECTRUM SPF 50 by is a Otc medication manufactured, distributed, or labeled by ESTEE LAUDER INC, ELGC K.K., Estee Lauder Pennsylvania Distribution Center 2 (PADC 2), ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER COSMETICS, LTD., ESTEE LAUDER N.V., LEN-RON MANUFACTURING DIVISION OF ARAMIS INC, NORTEC KEYSTONE, NORTHTEC BRISTOL, NORTHTEC KEYSTONE, WHITMAN LABORATORIES, LTD., Aveda Corporation, Pennsylvania Logistics Center. 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 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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11559-037
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)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11559-037-01	1 in 1 CARTON
1		30 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	10/01/2013

Labeler - ESTEE LAUDER INC (005914387)

Establishment
Name	Address	ID/FEI	Business Operations
ELGC K.K.		712808195	RELABEL(11559-037) , REPACK(11559-037)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)		828534516	MANUFACTURE(11559-037) , RELABEL(11559-037) , REPACK(11559-037)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(11559-037)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		205952385	MANUFACTURE(11559-037)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(11559-037)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(11559-037)

Establishment
Name	Address	ID/FEI	Business Operations
NORTEC KEYSTONE		943871157	MANUFACTURE(11559-037) , RELABEL(11559-037) , REPACK(11559-037)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC BRISTOL		959338336	MANUFACTURE(11559-037) , RELABEL(11559-037) , REPACK(11559-037)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC KEYSTONE		949264774	MANUFACTURE(11559-037) , RELABEL(11559-037) , REPACK(11559-037)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(11559-037)

Establishment
Name	Address	ID/FEI	Business Operations
Aveda Corporation		071352058	MANUFACTURE(11559-037)

Establishment
Name	Address	ID/FEI	Business Operations
Pennsylvania Logistics Center		078364654	REPACK(11559-037) , RELABEL(11559-037)