CODENATURE VIAMI TONE UP SHIELD CREAM- ethylhexyl methoxycinnamate, titanium dioxide, bis-ethylhexyloxyphenol methoxyphenyl triazine cream 
CODENATURE 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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Active Ingredients

Ethylhexyl Methoxycinnamate 6.8%

Titanium Dioxide (CI 77891) 3.95%

Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine 2.5%

Purpose

Sunscreen

Uses

Helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert : Spending time in the sun increases your

Risk of skin cancer and early skin aging. This product has been shown

Only to prevent sunburn, no skin cancer or early skin aging.

For external use only

Do not use

on damaged or broken skin

When using this product

keep out of eyes

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

Children under 6 months : Ask a doctor

Inactive Ingredients

Glycerin, Dipropylene Glycol, Phenethyl Benzoate, Terephthalylidene Dicamphor Sulfonic Acid,

Dimethicone, Dicaprylyl Carbonate, Alcohol Denat, Niacinamide, Tromethamine, Caprylyl Methicone

Diethylamino Hydroxybenzoyl Hexyl Benzoate, Pentylene Glycol, Potassium Cetyl Phosphate,

Glyceryl Stearate, PEG-100 Stearate, Isohexadecane, Cetyl Alcohol, Sorbitan Sesquioleate, Silica,

Camellia Sinensis Leaf Extract, Thymus Vulgaris (Thyme) Leaf Extract, Water

Other Information

Protect this product from excessive heat and direct sun

Package Label

30ml NDC: 78625-201-01 Label

CODENATURE VIAMI TONE UP SHIELD CREAM 
ethylhexyl methoxycinnamate, titanium dioxide, bis-ethylhexyloxyphenol methoxyphenyl triazine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78625-201
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6800 mg  in 100 mL
BEMOTRIZINOL (UNII: PWZ1720CBH) (BEMOTRIZINOL - UNII:PWZ1720CBH) BEMOTRIZINOL2500 mg  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3950 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
VERONICA OFFICINALIS FLOWERING TOP (UNII: 9IH82J936J)  
WATER (UNII: 059QF0KO0R)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
PEG-100 STEARATE (UNII: YD01N1999R)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T)  
MENTHA X ROTUNDIFOLIA LEAF (UNII: K59TXG2L3U)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)  
PROPANEDIOL (UNII: 5965N8W85T)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X)  
THYMUS VULGARIS LEAF (UNII: GRX3499643)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
ORANGE OIL (UNII: AKN3KSD11B)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
GLYCERIN (UNII: PDC6A3C0OX)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
PHENETHYL BENZOATE (UNII: 0C143929GK)  
ECAMSULE (UNII: M94R1PM439)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ALCOHOL (UNII: 3K9958V90M)  
NIACINAMIDE (UNII: 25X51I8RD4)  
TROMETHAMINE (UNII: 023C2WHX2V)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78625-201-0130 mL in 1 TUBE; Type 0: Not a Combination Product06/20/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/20/2020
Labeler - CODENATURE INC (690242086)
Registrant - CODENATURE INC (690242086)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax, Inc.689049693manufacture(78625-201)
Establishment
NameAddressID/FEIBusiness Operations
CODENATURE INC690242086label(78625-201)

Revised: 6/2020
Document Id: a884a14e-5f04-e8f0-e053-2a95a90a32c9
Set id: a884a14e-5f03-e8f0-e053-2a95a90a32c9
Version: 1
Effective Time: 20200620
 
CODENATURE INC