Label: DAYWEAR MULTI-PROTECTION ANTII-OXIDANT 24H-MOISTURE CREME BROAD SPECTRUM SPF 15 NORMAL/COMBINATION SKIN- avobenzone and octisalate cream
- NDC Code(s): 11559-049-01, 11559-049-02, 11559-049-03, 11559-049-04
- Packager: ESTEE LAUDER INC
- Category: HUMAN OTC DRUG LABEL
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 August 30, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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Uses
- helps prevent sunburn
- if used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun
- Warnings
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Directions
For sunscreen use:
- apply liberally and evenly 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 • butyloctyl salicylate • butylene glycol • polyester-8 • cetyl ricinoleate • steareth-21 • steareth-2 • di-c12-15 alkyl fumarate • caprylic/capric/myristic/stearic triglyceride • polysilicone-11 • psidium guajava (guava) fruit extract • gentiana lutea (gentian) root extract • polygonum cuspidatum root extract • stearyl alcohol • hordeum vulgare (barley) extract\extrait d'orge • laminaria ochroleuca extract • rosmarinus officinalis (rosemary) leaf extract • triticum vulgare (wheat) germ extract • artemia extract • caffeine • pentylene glycol • hydrolyzed rice extract • vitis vinifera (grape) seed extract • hydrolyzed rice bran extract • lauryl peg-9 polydimethylsiloxyethyl dimethicone • thermus thermophillus ferment • behenyl alcohol • acrylic acid/vp crosspolymer • triacontanyl pvp • glycerin • c12-15 alkyl benzoate • linoleic acid • cholesterol • squalane • sodium pca • 1,2-hexanediol • urea • caprylic/capric triglyceride • dipropylene glycol dibenzoate • tocopheryl acetate • acrylamide/sodium acryloyldimethyltaurate copolymer • tetrahexyldecyl ascorbate • sodium hyaluronate • ergothioneine • isohexadecane • ppg-15 stearyl ether benzoate • glycyrrhetinic acid • trehalose • polyquaternium-51 • polysorbate 80 • potassium sorbate • lecithin • hydrogenated lecithin • glucose • palmitoyl hydroxypropyltrimonium amylopectin/glycerin crosspolymer • caprylyl glycol • cyclodextrin • sodium hydroxide • nordihydroguaiaretic acid • sodium chloride • triacetin • ascorbyl tocopheryl maleate • fragrance (parfum) • citric acid • ethylbisiminomethylguaiacol manganese chloride • pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate • disodium edta • bht • chlorphenesin • sodium dehydroacetate • phenoxyethanol • blue 1 (ci 42090) • yellow 5 (ci 19140) • chromium hydroxide green (ci 77289) <iln48627>
- Other information
- PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton
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INGREDIENTS AND APPEARANCE
DAYWEAR MULTI-PROTECTION ANTII-OXIDANT 24H-MOISTURE CREME BROAD SPECTRUM SPF 15 NORMAL/COMBINATION SKIN
avobenzone and octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11559-049 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) CETYL RICINOLEATE (UNII: 1P677500YD) STEARETH-21 (UNII: 53J3F32P58) STEARETH-2 (UNII: V56DFE46J5) DI-C12-15 ALKYL FUMARATE (UNII: A1CB3Z898P) CAPRYLIC/CAPRIC/PALMITIC/STEARIC TRIGLYCERIDE (UNII: ZF29F7IK5I) GUAVA (UNII: 74O70D6VG0) GENTIANA LUTEA ROOT (UNII: S72O3284MS) REYNOUTRIA JAPONICA ROOT (UNII: 7TRV45YZF7) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) BARLEY (UNII: 5PWM7YLI7R) LAMINARIA OCHROLEUCA (UNII: 4R2124HE76) ROSEMARY (UNII: IJ67X351P9) WHEAT GERM (UNII: YR3G369F5A) FUMARIA OFFICINALIS FLOWERING TOP (UNII: VH659J61ZL) CAFFEINE (UNII: 3G6A5W338E) PENTYLENE GLYCOL (UNII: 50C1307PZG) RICE GERM (UNII: 7N2B70SFEZ) VITIS VINIFERA SEED (UNII: C34U15ICXA) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) THERMUS THERMOPHILUS LYSATE (UNII: 775R692494) DOCOSANOL (UNII: 9G1OE216XY) TRICONTANYL POVIDONE (UNII: N0SS3Q238D) GLYCERIN (UNII: PDC6A3C0OX) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) LINOLEIC ACID (UNII: 9KJL21T0QJ) CHOLESTEROL (UNII: 97C5T2UQ7J) SQUALANE (UNII: GW89575KF9) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) UREA (UNII: 8W8T17847W) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) DIPROPYLENE GLYCOL DIBENZOATE (UNII: 6OA5ZDY41O) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) HYALURONATE SODIUM (UNII: YSE9PPT4TH) ERGOTHIONEINE (UNII: BDZ3DQM98W) ISOHEXADECANE (UNII: 918X1OUF1E) PPG-15 STEARYL ETHER BENZOATE (UNII: 80D2J6361M) ENOXOLONE (UNII: P540XA09DR) TREHALOSE (UNII: B8WCK70T7I) POLYSORBATE 80 (UNII: 6OZP39ZG8H) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM CHLORIDE (UNII: 451W47IQ8X) ASCORBYL TOCOPHERYL MALEATE (UNII: D2G6259XR5) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) ETHYLBISIMINOMETHYLGUAIACOL MANGANESE CHLORIDE (UNII: SM5YJ88LTU) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) PHENOXYETHANOL (UNII: HIE492ZZ3T) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) CHROMIUM HYDROXIDE GREEN (UNII: RV8FT8XF5R) CHLORPHENESIN (UNII: I670DAL4SZ) TRIACETIN (UNII: XHX3C3X673) NORDIHYDROGUAIARETIC ACID, (+/-)- (UNII: 7PZ73W4ZNR) .BETA.-CYCLODEXTRIN SULFOBUTYL ETHER (UNII: H1HJ8WR7WG) TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S) (UNII: 587WKM3S9Q) GLUCOSE 1,6-BISPHOSPHATE (UNII: DRX17R6AM2) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) ACRYLAMIDE (UNII: 20R035KLCI) ACRYLIC ACID (UNII: J94PBK7X8S) RICE BRAN (UNII: R60QEP13IC) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11559-049-01 1 in 1 CARTON 12/01/2017 1 50 mL in 1 JAR; Type 0: Not a Combination Product 2 NDC:11559-049-02 1 in 1 CARTON 12/01/2022 2 15 mL in 1 JAR; Type 0: Not a Combination Product 3 NDC:11559-049-03 30 mL in 1 JAR; Type 0: Not a Combination Product 12/01/2022 4 NDC:11559-049-04 7 mL in 1 JAR; 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 12/01/2017 Labeler - ESTEE LAUDER INC (005914387) Registrant - Estee Lauder Companies Inc. (790802086) Establishment Name Address ID/FEI Business Operations PALC 078364654 pack(11559-049) , label(11559-049) Establishment Name Address ID/FEI Business Operations The Estee Lauder Inc 802599436 manufacture(11559-049) , pack(11559-049) , label(11559-049) Establishment Name Address ID/FEI Business Operations Northtec LLC 943871157 pack(11559-049) , label(11559-049) Establishment Name Address ID/FEI Business Operations PADC 1 949264774 pack(11559-049) , label(11559-049)
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