Label: REDNESS SOLUTIONS DAILY PROTECTIVE BASE BROAD SPECTRUM SPF 15- titanium dioxide and zinc oxide cream
- NDC Code(s): 49527-019-01, 49527-019-02
- Packager: CLINIQUE LABORATORIES LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated September 5, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 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 65 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 25 mg 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) LIMOSILACTOBACILLUS 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 2 NDC:49527-019-02 15 mL in 1 TUBE; Type 0: Not a Combination Product 12/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 12/01/2011 Labeler - CLINIQUE LABORATORIES LLC (044475127) Registrant - Estee Lauder Companies Inc. (790802086) Establishment Name Address ID/FEI Business Operations The Estee Lauder Inc 802599436 pack(49527-019) , label(49527-019) , manufacture(49527-019) Establishment Name Address ID/FEI Business Operations NORTHTEC LLC 943871157 pack(49527-019) , label(49527-019)
