![REDNESS SOLUTIONS DAILY PROTECTIVE BASE BROAD SPECTRUM SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [CLINIQUE LABORATORIES INC.]](https://medic.hrt.org//dailymed/images/d4133b2c-54e1-43de-98b4-7908a52f0905/redness-01.jpg)
| NDC | 49527-019-01 |
| Set ID | d4133b2c-54e1-43de-98b4-7908a52f0905 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | CLINIQUE LABORATORIES LLC |
| 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 • methyl trimethicone • octyldodecyl neopentanoate • c12-15 alkyl benzoate • butylene glycol • tricaprylyl citrate • steareth-2 trioctyldodecyl citrate • glyceryl stearate • peg-100 stearate • barium sulfate • silica • ascophyllum nodosum extract • asparagopsis armata extract • sea whip extract • tocopheryl acetate • sucrose • pantethine • caffeine • dimethicone • cetearyl alcohol • isostearic acid • polyhydroxystearic acid • bisabolol • magnesium ascorbyl phosphate • lactobacillus ferment • sodium hyaluronate • sorbitol • phytosphingosine • caprylyl glycol • aluminum hydroxide • stearic acid • hexylene glycol • xanthan gum • disodium edta • phenoxyethanol • iron oxides (ci 77491, ci 77492, ci 77499) • chromium hydroxide green (ci 77289) [iln39531]
- Other information
- PRINCIPAL DISPLAY PANEL - 40 ml Bottle Carton
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INGREDIENTS AND APPEARANCE
REDNESS SOLUTIONS DAILY PROTECTIVE BASE BROAD SPECTRUM SPF 15
titanium dioxide and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49527-019 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.0698 g in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.0268 g in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) METHYL TRIMETHICONE (UNII: S73ZQI0GXM) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) TRICAPRYLYL CITRATE (UNII: BXW1GAI4TA) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) BARIUM SULFATE (UNII: 25BB7EKE2E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5) SUCROSE (UNII: C151H8M554) PANTETHINE (UNII: 7K81IL792L) CAFFEINE (UNII: 3G6A5W338E) DIMETHICONE (UNII: 92RU3N3Y1O) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) ISOSTEARIC ACID (UNII: X33R8U0062) LEVOMENOL (UNII: 24WE03BX2T) MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5) LACTOBACILLUS REUTERI (UNII: 9913I24QEE) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SORBITOL (UNII: 506T60A25R) PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) HEXYLENE GLYCOL (UNII: KEH0A3F75J) XANTHAN GUM (UNII: TTV12P4NEE) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) CHROMIUM HYDROXIDE GREEN (UNII: RV8FT8XF5R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49527-019-01 1 in 1 CARTON 12/01/2011 1 40 mL in 1 BOTTLE; 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 12/01/2011 Labeler - CLINIQUE LABORATORIES LLC (044475127) Registrant - Estee Lauder Companies Inc. (790802086) Establishment Name Address ID/FEI Business Operations Whitman Laboratories Ltd. 216866277 MANUFACTURE(49527-019) , REPACK(49527-019) , RELABEL(49527-019) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COMPANY, THE 828534516 REPACK(49527-019) , RELABEL(49527-019) Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics Ltd. 202952982 MANUFACTURE(49527-019) , REPACK(49527-019) , RELABEL(49527-019) Establishment Name Address ID/FEI Business Operations Estee Lauder N.V. 370151326 MANUFACTURE(49527-019) , REPACK(49527-019) , RELABEL(49527-019) Establishment Name Address ID/FEI Business Operations Len-Ron Manufacturing Division of Aramis Inc. 809771152 MANUFACTURE(49527-019) , REPACK(49527-019) , RELABEL(49527-019) Establishment Name Address ID/FEI Business Operations NORTHTEC INC 943871157 REPACK(49527-019) , RELABEL(49527-019) Establishment Name Address ID/FEI Business Operations PADC 1 949264774 REPACK(49527-019) , RELABEL(49527-019) Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics Ltd 204132062 REPACK(49527-019) , RELABEL(49527-019) Establishment Name Address ID/FEI Business Operations NORTHTEC PALC 102631997 REPACK(49527-019) , RELABEL(49527-019)
