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NDC 69842-0801-01 Nuance Salma Hayek Renewed Radiance Brightening BB Cream Broad Spectrum SPF 30 Sunscreen 7.5; 10 g/100g; g/100g Details

Nuance Salma Hayek Renewed Radiance Brightening BB Cream Broad Spectrum SPF 30 Sunscreen 7.5; 10 g/100g; g/100g

Nuance Salma Hayek Renewed Radiance Brightening BB Cream Broad Spectrum SPF 30 Sunscreen is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by CVS Pharmacy, Inc. The primary component is OCTINOXATE; TITANIUM DIOXIDE.

Product Information

NDC	69842-0801
Product ID	69842-801_4663a201-42a7-692b-e054-00144ff88e88
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Nuance Salma Hayek Renewed Radiance Brightening BB Cream Broad Spectrum SPF 30 Sunscreen
Proprietary Name Suffix	n/a
Non-Proprietary Name	Nuance Salma Hayek Renewed Radiance Brightening BB Cream Broad Spectrum SPF 30 Sunscreen
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	7.5; 10
Active Ingredient Units	g/100g; g/100g
Substance Name	OCTINOXATE; TITANIUM DIOXIDE
Labeler Name	CVS Pharmacy, Inc
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part352
Listing Certified Through	2024-12-31

Package

Package Images

NDC 69842-0801-01 (69842080101)

Pricing Information	N/A
NDC Package Code	69842-801-01
Billing NDC	69842080101
Package	30 g in 1 TUBE (69842-801-01)
Marketing Start Date	2017-01-18
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 7795e651-838e-41f8-b48d-bd2e0dd1beec Details

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:69842-801
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69842-801-01	30 g in 1 TUBE; Type 0: Not a Combination Product	01/18/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	01/18/2017

Labeler - CVS Pharmacy, Inc (062312574)

Revised: 1/2017

Document Id: 4663a201-42a7-692b-e054-00144ff88e88

Set id: 7795e651-838e-41f8-b48d-bd2e0dd1beec

Version: 1

Effective Time: 20170118