![CYBERWHITE HD UV PROTECTOR BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [ESTEE LAUDER INC]](https://medic.hrt.org//dailymed/images/55929d6e-4576-4952-8e19-72694d2da092/elyj8t-01.jpg)
| NDC | 11559-037-01 |
| Set ID | 55929d6e-4576-4952-8e19-72694d2da092 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | ESTEE LAUDER INC |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Use
- Warnings
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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
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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
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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
- PRINCIPAL DISPLAY PANEL - 30ml Bottle Carton
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INGREDIENTS AND APPEARANCE
CYBERWHITE HD UV PROTECTOR BROAD SPECTRUM SPF 50
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotionProduct 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)
