Label: NUANCE SALMA HAYEK RENEWED RADIANCE BRIGHTENING BB CREAM BROAD SPECTRUM SPF 30 SUNSCREEN lotion

  • 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 January 18, 2017

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  • Active Ingredients

    Octinoxate 7.50%

    Titanium Dioxide 10%

  • Use

    • 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

    • For external use only
    • Do not use on damaged or broken skin
    • When using this product keep out of eyes. Rinse with water to remove.
    • Stop use and ask a docor if rash occurs
    • Keep out of reach of children. If swalled, get medical help or contact a Poison Control Center right away.
  • Directions

    • Apply liberally 15 minutes before sun exposure
    • Reapply at least every 2 hours
    • Use water resistant sunscreen if swimming or sweathing
    • Sun Protection Measures: Spending time in the sun decreases risk of skin cancer and early again. To decrease this risk, regulaory 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 10:00 am - 2:00 pm. Wear long sleeved shirts, pants, hats and sunglasses.
    • Children under 6 months: ask a doctor
  • Inactive Ingredients

    WATER (AQUA), CAPRYLIC./CAPRIC/MYRISTIC/STEARIC TRIGLYCERIDE,
    OCTYLDODECYL NEOPENTANOATE, Cl2-15 ALKYL
    BENZOATE, BUffiENE GLYCOL, BEHENYL ALCOHOL, STEARETH-2,
    STEARETH-21, STEARIC ACID, TRIETHYLHEXANOIN, ISOSTEARIC
    ACID, POLYGLYCERYL-3 DIISOSTEARATE, CETYL ALCOHOL,
    TOCOPHEROL, TOCOPHERYL ACETATE, TETRAHEXYLOECYL
    ASCORBATE, ALBIZIA JULIBRISSIN BARK EXTRACT, CALENDULA
    OFFICINALIS FLOWER EXTRACT, GLYCYRRHIZA GLABRA ROOT
    EXTRACT, PHYSALIS ANGULATA EXTRACT, ACHRAS SAPOTA
    (MAMEY) EXTRACT, LYCIUM BARBARUM FRUIT EXTRACT,
    CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, TREMELLA
    FUCIFORMIS SPOROCARP EXTRACT, HYDROGENATED LECITH IN,
    PANTHENOL, SQUALANE, GLYCERIN, CERAMIDE NG, PEG-10
    PHYTOSTEROL, PALMITOYL HEXAPEPTIDE-12, PALMITOYL
    HEXAPEPTIDE-14, MAGNESIUM CHLORIDE, POTASSIUM
    CHLORIDE, SODIUM CHLORIDE, ZINC CHLORIDE, LYSINE,
    PHYTDSTERYUISOSTEARYL/CETYUSTEARYUBEHENYL DIMER
    DILINOLEATE, SODIUM HYALURONATE CROSSPOLYMER,
    DIMETHYLACRYLAMIDE/ACRYLIC ACID/POLYSTYRENE ETHYL
    METHACRYLATE COPOLYMER, POLYSORBATE 80, STEARYL
    ALCOHOL, PHYTANTRIOL, XANTHAN GUM, SIMETHICONE,
    CELLULOSE GUM, ALUMINA, PENTYLENE GLYCOL, ETHOXYDIGLYCOL,
    TRIETHOXYCAPRYLYLSILANE, TRIBEHEN IN, BETAINE,
    HEXYLENE GLYCOL, DISODIUM EDTA, CITRIC ACID, SODIUM
    BENZOATE, POTASSIUM SORBATE, SODIUM DEHYDROACETATE,
    ETHYLHEXYLGLYCERIN, CAPRYLYL GLYCOL, PHENOXYETHANOL,
    FRAGRANCE (PARFUM). MAY CONTAIN C+/·l: IRON OXIDES
    (Cl 77492), MICA, IRON OXIDES (Cl 77491), TITANIUM DIOXIDE
    (Cl 77891), IRON OXIDES (Cl 77499).

  • Other Information

    • Protect this product form excessive heat and direct sun
    • Save Carton for full directions and warnings
  • Principal Display Panel

    69842-801-01

  • INGREDIENTS AND APPEARANCE
    NUANCE SALMA HAYEK RENEWED RADIANCE BRIGHTENING BB CREAM BROAD SPECTRUM SPF 30 SUNSCREEN 
    nuance salma hayek renewed radiance brightening bb cream broad spectrum spf 30 sunscreen lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-801
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CAPRYLIC/CAPRIC/PALMITIC/STEARIC TRIGLYCERIDE (UNII: ZF29F7IK5I)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    C12-15 ALKYL LACTATE (UNII: GC844VRD7E)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    BEHENYL BENZOATE (UNII: DQG8119XKJ)  
    STEARETH-2 (UNII: V56DFE46J5)  
    STEARETH-21 (UNII: 53J3F32P58)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    ALBIZIA JULIBRISSIN BARK (UNII: 0J9G6W44DV)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    PHYSALIS ANGULATA (UNII: W4TKW9D5GG)  
    LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)  
    CARTHAMUS TINCTORIUS FLOWER OIL (UNII: SDQ136WIM5)  
    TREMELLA FUCIFORMIS WHOLE (UNII: 4938BNS0GU)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    SQUALANE (UNII: GW89575KF9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CERAMIDE NG (UNII: C04977SRJ5)  
    PEG-10 .BETA.-SITOSTEROL (UNII: K9X3A45CI6)  
    PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ZINC CHLORIDE (UNII: 86Q357L16B)  
    LYSINE (UNII: K3Z4F929H6)  
    PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER (UNII: 788QAG3W8A)  
    N,N-DIMETHYLACRYLAMIDE (UNII: AS46JK7Q6I)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    PHYTANTRIOL (UNII: 8LVI07A72W)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CELLULOSE ACETATE (UNII: 3J2P07GVB6)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    ETHOXYDIGLYCOL BEHENATE (UNII: N76ISC4ZZO)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    BETAINE (UNII: 3SCV180C9W)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-801-0130 g in 1 TUBE; Type 0: Not a Combination Product01/18/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/18/2017
    Labeler - CVS Pharmacy, Inc (062312574)