Label: SUPERDEFENSE BROAD SPECTRUM SPF 25 FATIGUE PLUS 1ST SIGNS OF AGE MULTI-CORRECTING- avobenzone and octisalate cream
- NDC Code(s): 49527-075-01, 49527-075-02
- 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 11, 2023
If you are a consumer or patient please visit this version.
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- 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 • glycerin • neopentyl glycol diheptanoate • polyester-8 • dimethicone • sorbitan stearate • butyloctyl salicylate • polysorbate 60 • butylene glycol • sodium acrylates copolymer • silica • cetyl alcohol • niacinamide • pentylene glycol • brassica oleracea gemmifera (brussels sprouts) extract • vaccinium angustifolium (blueberry) fruit extract • brassica oleracea italica (broccoli) extract • daucus carota sativa (carrot) root extract • brassica oleracea acephala (kale) leaf extract • spinacia oleracea (spinach) leaf extract • resveratrol • plankton extract • oryza sativa (rice) bran extract • vaccinium macrocarpon (cranberry) fruit extract • cucumis sativus (cucumber) fruit extract • adenosine phosphate • salicylic acid • laminaria saccharina extract • creatine • arabidopsis thaliana extract • lactobacillus ferment • ergothioneine • micrococcus lysate • biosaccharide gum-4 • algae extract • acetyl carnitine hcl • caffeine • hordeum vulgare (barley) extract\extrait d'orge • albizia julibrissin bark extract • sigesbeckia orientalis (st. paul's wort) extract • sodium rna • sodium hyaluronate • 7-dehydrocholesterol • styrene/acrylates copolymer • isohexadecane • tocopheryl acetate • peg-100 stearate • trehalose • ethylhexylglycerin • lecithin • propylene glycol dicaprate • polyethylene • helianthus annuus (sunflower) seedcake • yeast extract\faex\extrait de levure • capryloyl glycine • peg-8 laurate • polysorbate 80 • acrylamide/sodium acryloyldimethyltaurate copolymer • phytic acid • sea whip extract • tetrahexyldecyl ascorbate • propylene glycol caprylate • disodium edta • bht • chlorphenesin • phenoxyethanol • titanium dioxide (ci 77891) • mica [iln44660]
- Other information
- PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton
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INGREDIENTS AND APPEARANCE
SUPERDEFENSE BROAD SPECTRUM SPF 25 FATIGUE PLUS 1ST SIGNS OF AGE MULTI-CORRECTING
avobenzone and octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49527-075 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.0306 g in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 0.051 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) DIMETHICONE (UNII: 92RU3N3Y1O) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) POLYSORBATE 60 (UNII: CAL22UVI4M) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CETYL ALCOHOL (UNII: 936JST6JCN) NIACINAMIDE (UNII: 25X51I8RD4) PENTYLENE GLYCOL (UNII: 50C1307PZG) BRUSSELS SPROUT (UNII: KHX46H31F8) LOWBUSH BLUEBERRY (UNII: G90PX41VP0) BROCCOLI (UNII: UOI4FT57BZ) CARROT (UNII: L56Z1JK48B) KALE (UNII: 0Y3L4J38H1) SPINACH (UNII: 6WO75C6WVB) RESVERATROL (UNII: Q369O8926L) RICE BRAN (UNII: R60QEP13IC) CRANBERRY (UNII: 0MVO31Q3QS) CUCUMBER (UNII: YY7C30VXJT) ADENOSINE PHOSPHATE (UNII: 415SHH325A) SALICYLIC ACID (UNII: O414PZ4LPZ) SACCHARINA LATISSIMA (UNII: 68CMP2MB55) CREATINE (UNII: MU72812GK0) ARABIDOPSIS THALIANA WHOLE (UNII: AI3L60HQ81) LIMOSILACTOBACILLUS REUTERI (UNII: 9913I24QEE) ERGOTHIONEINE (UNII: BDZ3DQM98W) BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90) LEVACECARNINE HYDROCHLORIDE (UNII: NDW10MX58T) CAFFEINE (UNII: 3G6A5W338E) BARLEY (UNII: 5PWM7YLI7R) ALBIZIA JULIBRISSIN BARK (UNII: 0J9G6W44DV) HYALURONATE SODIUM (UNII: YSE9PPT4TH) 7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF) ISOHEXADECANE (UNII: 918X1OUF1E) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PEG-100 STEARATE (UNII: YD01N1999R) TREHALOSE (UNII: B8WCK70T7I) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) PROPYLENE GLYCOL DICAPRATE (UNII: U783H9JHWY) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) HELIANTHUS ANNUUS SEEDCAKE (UNII: 482WYF7XLC) YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U) CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ) PEG-8 LAURATE (UNII: 762O8IWA10) POLYSORBATE 80 (UNII: 6OZP39ZG8H) FYTIC ACID (UNII: 7IGF0S7R8I) PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) PROPYLENE GLYCOL MONOCAPRYLATE (UNII: RT9P9S09QI) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CHLORPHENESIN (UNII: I670DAL4SZ) PHENOXYETHANOL (UNII: HIE492ZZ3T) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) MICA (UNII: V8A1AW0880) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49527-075-01 1 in 1 CARTON 11/21/2019 1 50 mL in 1 JAR; Type 0: Not a Combination Product 2 NDC:49527-075-02 7 mL in 1 TUBE; Type 0: Not a Combination Product 11/21/2019 09/11/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 11/21/2019 Labeler - CLINIQUE LABORATORIES LLC (044475127) Registrant - Estee Lauder Companies Inc. (790802086) Establishment Name Address ID/FEI Business Operations PALC 078364654 pack(49527-075) , label(49527-075) Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics Ltd. 204132062 pack(49527-075) , label(49527-075) Establishment Name Address ID/FEI Business Operations Whitman Laboratories Ltd. 216866277 manufacture(49527-075) , pack(49527-075) , label(49527-075) Establishment Name Address ID/FEI Business Operations Estee Lauder N.V. 370151326 manufacture(49527-075) , pack(49527-075) , label(49527-075) Establishment Name Address ID/FEI Business Operations The Estee Lauder Inc 802599436 manufacture(49527-075) , pack(49527-075) , label(49527-075) Establishment Name Address ID/FEI Business Operations NORTHTEC LLC 943871157 label(49527-075) , pack(49527-075) Establishment Name Address ID/FEI Business Operations PADC 1 949264774 pack(49527-075) , label(49527-075)
