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NDC 59779-0777-01 NUANCE Salma Hayek Renewed Radiance Moisturizing Day Cream Broad Spectrum SPF 30 Sunscreen 3; 7.5; 5 g/100g; g/100g; g/100g Details

NUANCE Salma Hayek Renewed Radiance Moisturizing Day Cream Broad Spectrum SPF 30 Sunscreen 3; 7.5; 5 g/100g; g/100g; g/100g

NUANCE Salma Hayek Renewed Radiance Moisturizing Day 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 AVOBENZONE; OCTINOXATE; OCTISALATE.

Product Information

NDC	59779-0777
Product ID	59779-777_46643cbb-edd8-1292-e054-00144ff8d46c
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 Moisturizing Day Cream Broad Spectrum SPF 30 Sunscreen
Proprietary Name Suffix	n/a
Non-Proprietary Name	NUANCE Salma Hayek Renewed Radiance Moisturizing Day Cream Broad Spectrum SPF 30 Sunscreen
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	3; 7.5; 5
Active Ingredient Units	g/100g; g/100g; g/100g
Substance Name	AVOBENZONE; OCTINOXATE; OCTISALATE
Labeler Name	CVS Pharmacy, Inc
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2024-12-31

Package

Package Images

NDC 59779-0777-01 (59779077701)

Pricing Information	N/A
NDC Package Code	59779-777-01
Billing NDC	59779077701
Package	1 TUBE in 1 PACKAGE (59779-777-01) / 40 g in 1 TUBE
Marketing Start Date	2017-01-18
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL cca5d399-5017-4b8d-8a19-3f6370664c18 Details

Active Ingredients

Avobenzone 3.00%

Octinoxate 7.50%

Octisalate 5.0%

Use

Helps prevent sunburn. If used as directed with other sun protection measures, helps decrease the risk of skin cancer and early signs of 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
Use water resistant sunscreen if swimming or sweathing
Reapply at least every 2 hours
Children under 6 months: ask a doctor
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.

Inactive Ingredients

Water (Aqua, Eau), Octyldodecyl Neopentanoate, C12-15 Alkyl Benzoate, Butylene Glycol, Mica, Titanium Dioxide (CI 77891), Glycerin, Simmondsia Chinensis Seed Oil, Butyrospermum Parkii (Shea) Butter, Hexapeptide-33, Stearic Acid, Behenyl Alcohol, Glyceryl Stearate, Lecithin,Myristyl Alcohol, Lauryl Alcohol, Cetyl Alcohol, Palmitic Acid, Cetearyl Alcohol, Coco-Glucoside, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Prunus Armeniaca Kernel Oil, Carica Papaya Fruit Extract, Cymbopogon Schoenanthus Extract, Aesculus Hippocastanum Seed Extract, Aloe Barbadensis Leaf Extract, Polysorbate 20, Sorbitan Laurate, Propylene Glycol Stearate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Carbomer, Sodium Hydroxide, Propylene Glycol Laurate, Ethylhexylglycerin, Disodium Edta, Phenoxyethanol, o-Cymen-5-Ol, Fragrance (Parfum), Benzyl Alcohol, Benzyl Salicylate, Butylphenyl Methylpropional, d-Limonene

Other Information

Protect this product form excessive heat and direct sun

Principal Display Panel

INGREDIENTS AND APPEARANCE

NUANCE SALMA HAYEK RENEWED RADIANCE MOISTURIZING DAY CREAM BROAD SPECTRUM SPF 30 SUNSCREEN

nuance salma hayek renewed radiance moisturizing day cream broad spectrum spf 30 sunscreen lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59779-777
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
GLYCERIN (UNII: PDC6A3C0OX)
SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)
SHEA BUTTER (UNII: K49155WL9Y)
STEARIC ACID (UNII: 4ELV7Z65AP)
BEHENYL BENZOATE (UNII: DQG8119XKJ)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
MYRISTYL ALCOHOL (UNII: V42034O9PU)
LAURYL ALCOHOL (UNII: 178A96NLP2)
CETYL ALCOHOL (UNII: 936JST6JCN)
PALMITIC ACID (UNII: 2V16EO95H1)
COCO GLUCOSIDE (UNII: ICS790225B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
PRUNUS ARMENIACA LEAF (UNII: 0X5YG5R83N)
CARICA PAPAYA LEAF (UNII: 66J7636Z2I)
CYMBOPOGON SCHOENANTHUS OIL (UNII: XE7K568ILO)
AESCULUS HIPPOCASTANUM LEAF (UNII: Z49U891FNQ)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SORBITAN OLIVATE (UNII: MDL271E3GR)
PROPYLENE GLYCOL STEARATE (UNII: MZM1I680W0)
CARBOMER 940 (UNII: 4Q93RCW27E)
SODIUM HYDRIDE (UNII: 23J3BHR95O)
PROPYLENE GLYCOL LAURATES (UNII: 40KT317HGP)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
O-CYMEN-5-OL (UNII: H41B6Q1I9L)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:59779-777-01	1 in 1 PACKAGE	01/18/2017
1		40 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	01/18/2017

Labeler - CVS Pharmacy, Inc (062312574)

Revised: 1/2017

Document Id: 46643cbb-edd8-1292-e054-00144ff8d46c

Set id: cca5d399-5017-4b8d-8a19-3f6370664c18

Version: 1

Effective Time: 20170118