![SUPERDEFENSE AGE DEFENSE MOISTURIZER BROAD SPECTRUM SPF 25 VERY DRY TO DRY (OCTISALATE, OXYBENZONE, AND AVOBENZONE) CREAM [CLINIQUE LABORATORIES INC.]](https://medic.hrt.org//dailymed/images/9f68c46b-accd-47bd-bc79-84b37f5e097d/cl68gk-01.jpg)
| NDC | 49527-034-01 |
| Set ID | 9f68c46b-accd-47bd-bc79-84b37f5e097d |
| Category | HUMAN OTC DRUG LABEL |
| Packager | CLINIQUE LABORATORIES INC. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
- 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 • dimethicone • petrolatum • butylene glycol • butyloctyl salicylate • polyglyceryl-2 triisostearate • caprylic/capric/myristic/stearic triglyceride • polyester-8 • glyceryl stearate • peg-100 stearate • coffea robusta seed extract • echinacea pallida (coneflower) extract • rosmarinus officinalis (rosemary) extract • sea whip extract • isopropyl ppg-2-isodeceth-7 carboxylate • padina pavonica (thallus) extract • micrococcus lysate • disodium nadh • trehalose • creatine • sodium rna • caffeine • nordihydroguaiaretic acid • sodium dna • astrocaryum murumuru seed butter • phytosphingosine • linoleic acid • cholesterol • ascorbyl tocopheryl maleate • algae extract • sodium hyaluronate • aminopropyl ascorbyl phosphate • tocopheryl acetate • adenosine phosphate • laurdimonium hydroxypropyl hydrolyzed soy protein • chamomilla recutita (matricaria) • decarboxy carnosine hcl • ethylhexyl stearate • caprylyl glycol • isohexadecane • polyethylene • zeolite • lecithin • behenyl alcohol • xanthan gum • potassium sulfate • polysorbate 80 • steareth-21 • acrylamide/sodium acryloyldimethyltaurate copolymer • ammonium acryloyldimethyltaurate/vp copolymer • sucrose • tromethamine • carbomer • glycerin • ethylhexyl palmitate • arginine ferulate • propylene glycol dicaprate • hexylene glycol • disodium edta • phenoxyethanol [iln36954]
- Other information
- PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton
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INGREDIENTS AND APPEARANCE
SUPERDEFENSE AGE DEFENSE MOISTURIZER BROAD SPECTRUM SPF 25 VERY DRY TO DRY
octisalate, oxybenzone, and avobenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49527-034 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 0.0508 g in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0508 g in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.0305 g in 1 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) dimethicone (UNII: 92RU3N3Y1O) petrolatum (UNII: 4T6H12BN9U) butylene glycol (UNII: 3XUS85K0RA) butyloctyl salicylate (UNII: 2EH13UN8D3) glyceryl monostearate (UNII: 230OU9XXE4) peg-100 stearate (UNII: YD01N1999R) robusta coffee bean (UNII: V5032728L7) echinacea pallida (UNII: 904CK3270L) rosemary (UNII: IJ67X351P9) pseudopterogorgia elisabethae (UNII: UDY3H1OUX5) padina pavonica (UNII: 177U06NHZI) trehalose (UNII: B8WCK70T7I) creatine (UNII: MU72812GK0) caffeine (UNII: 3G6A5W338E) masoprocol (UNII: 7BO8G1BYQU) astrocaryum murumuru seed butter (UNII: 12V64UPU6R) phytosphingosine (UNII: GIN46U9Q2Q) linoleic acid (UNII: 9KJL21T0QJ) cholesterol (UNII: 97C5T2UQ7J) ascorbyl tocopheryl maleate (UNII: D2G6259XR5) hyaluronate sodium (UNII: YSE9PPT4TH) aminopropyl ascorbyl phosphate (UNII: 290O2PQ83R) .alpha.-tocopherol acetate (UNII: 9E8X80D2L0) adenosine phosphate (UNII: 415SHH325A) decarboxy carnosine Hydrochloride (UNII: 6X7K9I5QR7) ethylhexyl stearate (UNII: EG3PA2K3K5) caprylyl glycol (UNII: 00YIU5438U) isohexadecane (UNII: 918X1OUF1E) high density polyethylene (UNII: UG00KM4WR7) docosanol (UNII: 9G1OE216XY) xanthan gum (UNII: TTV12P4NEE) potassium sulfate (UNII: 1K573LC5TV) polysorbate 80 (UNII: 6OZP39ZG8H) steareth-21 (UNII: 53J3F32P58) sucrose (UNII: C151H8M554) ammonium acryloyldimethyltaurate/vp copolymer (UNII: W59H9296ZG) tromethamine (UNII: 023C2WHX2V) glycerin (UNII: PDC6A3C0OX) ethylhexyl palmitate (UNII: 2865993309) propylene glycol dicaprate (UNII: U783H9JHWY) hexylene glycol (UNII: KEH0A3F75J) edetate disodium (UNII: 7FLD91C86K) phenoxyethanol (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49527-034-01 1 in 1 CARTON 1 50 mL in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 06/01/2010 Labeler - CLINIQUE LABORATORIES INC. (173047747) Establishment Name Address ID/FEI Business Operations ELGC K.K. 712808195 RELABEL(49527-034) , REPACK(49527-034) Establishment Name Address ID/FEI Business Operations Estee Lauder Pennsylvania Distribution Center 2 (PADC 2) 828534516 MANUFACTURE(49527-034) , RELABEL(49527-034) , REPACK(49527-034) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS DISTRIBUTION CENTER 208579636 REPACK(49527-034) , RELABEL(49527-034) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 244669714 MANUFACTURE(49527-034) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD. 205952385 MANUFACTURE(49527-034) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER N.V. 370151326 MANUFACTURE(49527-034) Establishment Name Address ID/FEI Business Operations LEN-RON MANUFACTURING DIVISION OF ARAMIS INC 809771152 MANUFACTURE(49527-034) Establishment Name Address ID/FEI Business Operations NORTEC KEYSTONE 943871157 MANUFACTURE(49527-034) , RELABEL(49527-034) , REPACK(49527-034) Establishment Name Address ID/FEI Business Operations NORTHTEC BRISTOL 959338336 MANUFACTURE(49527-034) , RELABEL(49527-034) , REPACK(49527-034) Establishment Name Address ID/FEI Business Operations NORTHTEC KEYSTONE 949264774 MANUFACTURE(49527-034) , RELABEL(49527-034) , REPACK(49527-034) Establishment Name Address ID/FEI Business Operations WHITMAN LABORATORIES, LTD. 216866277 MANUFACTURE(49527-034) Establishment Name Address ID/FEI Business Operations Aveda Corporation 071352058 MANUFACTURE(49527-034) Establishment Name Address ID/FEI Business Operations Pennsylvania Logistics Center 078364654 REPACK(49527-034) , RELABEL(49527-034)
