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

Nuance Salma Hayek Renewed Radiance Brightening BB Cream Broad Spectrum SPF 30 Sunscreen by

Drug Labeling and Warnings

Nuance Salma Hayek Renewed Radiance Brightening BB Cream Broad Spectrum SPF 30 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Mana Products. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59735-140
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59735-140-01	30 g in 1 TUBE; Type 0: Not a Combination Product	09/08/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	09/08/2016

Labeler - Mana Products (078870292)