29 by LYDIA MONDAVI Napa Valley BROAD SPECTRUM SPF 30 D'VINE DAY CREAM

29 by LYDIA MONDAVI Napa Valley BROAD SPECTRUM SPF 30 D VINE DAY by

Drug Labeling and Warnings

29 by LYDIA MONDAVI Napa Valley BROAD SPECTRUM SPF 30 D VINE DAY by is a Otc medication manufactured, distributed, or labeled by 29 Luxury Goods, Inc., Hunter Amenities International Limited, Product Quest Mfg, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

29 BY LYDIA MONDAVI NAPA VALLEY BROAD SPECTRUM SPF 30 D VINE DAY- avobenzone, homosalate, octisalate, octocrylene, oxybenzone cream 
29 Luxury Goods, Inc.

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.

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29 by LYDIA MONDAVI Napa Valley BROAD SPECTRUM SPF 30 D'VINE DAY CREAM

29 by LYDIA MONDAVI Napa Valley BROAD SPECTRUM SPF 30 D'VINE DAY CREAM

Active Ingredients

Avobenzone  3% w/w
Homosalate   10% w/w
Octisalate     5% w/w
Octocrylene  2% w/w
Oxybenzone 2.5% w/w

Purpose

Sunscreen

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

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 doctor

if rash occurs

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply liberally 15 minutes before sun exposure
• reapply:
  
• • after 40 minutes of swimming or sweating
• • Immediately after towel drying
• • at least every 2 hours
• Sun Protection Measures. Spending time in the sun Increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad spectrum SPF 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 sleeve shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor
  

Inactive Ingredients

Water, Styrene/Acrylates Copolymer, Butyloctyl Salicylate, Silica, Glyceryl Stearate, Peg-100 Stearate, VP/Hexadecene Copolymer, Polyester-8, 1,2 Hexanediol, Caprylyl Glycol, Caprylyl Methicone, Ethylhexyl Stearate, Trideceth-6, Dimethicone, Trimethylsiloxysilicate, Sodium Polyacrylate, Behenyl Alcohol, Dimethyl Capramide, Ethylhexylglycerin, Xanthan Gum, Niacinamide, Calcium Pantothenate, Sodium Ascorbyl Phosphate, Tocopheryl Acetate, Pyridoxine HCL, Maltodextrin, Sodium Starch Octenylsuccinate, Disodium Edta, BHT, Lepidium Sativum Sprout Extract, Lecithin, Glycerin, Phenoxyethanol, Vitis Vinifers Seed extract, Fragrance/Parfum

Other information

• protect this product from excessive heat and direct sun
  

Questions or Comments?

Call toll free 1-800-668-1483

29 by LYDIA MONDAVI Napa Valley BROAD SPECTRUM SPF 30 D'VINE DAY CREAM 2oz/60ml | 29 by LYDIA MONDAVI Napa Valley BROAD SPECTRUM SPF 30 D'VINE DAY CREAM 0.5oz/15ml

29 BY LYDIA MONDAVI NAPA VALLEY BROAD SPECTRUM SPF 30 D VINE DAY 
avobenzone, homosalate, octisalate, octocrylene, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24663-000
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
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	20 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	25 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
STYRENE (UNII: 44LJ2U959V)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT) (UNII: AG75W62QYU)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
DIMETHICONE (UNII: 92RU3N3Y1O)
DOCOSANOL (UNII: 9G1OE216XY)
DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
XANTHAN GUM (UNII: TTV12P4NEE)
NIACINAMIDE (UNII: 25X51I8RD4)
CALCIUM PANTOTHENATE (UNII: 568ET80C3D)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
OCTENYLSUCCINIC ACID (UNII: 12UZE4X73L)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
GARDEN CRESS SPROUT (UNII: PWQ18YNR62)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
VITIS VINIFERA SEED (UNII: C34U15ICXA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24663-000-01	1 in 1 CARTON	10/16/2013	01/31/2019
1		60 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 24663-000-00	1 in 1 PACKAGE	10/16/2013	01/31/2019
2		15 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/16/2013	01/31/2019

Labeler - 29 Luxury Goods, Inc. (618642156)

Revised: 2/2020

Document Id: 9f6a3aeb-2e2a-41aa-e053-2995a90a55f8

34390-5

Set id: 73fc60e6-66bb-48b3-a73e-3e1b4fff694b

Version: 2

Effective Time: 20200225