GUINOT HYDRA FINISH FACE CREAM SPF15- homosalate, octinoxate, titanium dioxide cream 
GUINOT Institut Paris

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.

----------

GUINOT HYDRA FINISH Face Cream SPF15

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 at least every 2 hours

Use a water resistant sunscreen if swimming or sweating

Sun Protection Measures.

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this 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

Active ingredients and Purpose

Active ingredients

Hommosalate 4.0 %

Octinoxate 6.0 %

Titanium Dioxide 4.8 %

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

GUINOT Institut Paris

HYDRA F Etui Hydra FinishINISH Face Cream

Face Moisturiser Complexion Enhancer SPF15-Broadspectrum sunscreen

Mallow extract

NET WT 0.88 OZ

GUINOT HYDRA FINISH FACE CREAM SPF15 
homosalate, octinoxate, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54181-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE1.26 g  in 31.5 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.512 g  in 31.5 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.89 g  in 31.5 g
Inactive Ingredients
Ingredient NameStrength
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
TROLAMINE (UNII: 9O3K93S3TK)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SUCROSE (UNII: C151H8M554)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
BEMOTRIZINOL (UNII: PWZ1720CBH)  
MALVA SYLVESTRIS WHOLE (UNII: I01732476C)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
AMMONIO METHACRYLATE COPOLYMER TYPE A (UNII: 8GQS4E66YY)  
ACRYLIC ACID (UNII: J94PBK7X8S)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)  
RAPESEED STEROL (UNII: B46B6DD20U)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)  
CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)  
HEXYLDECANOL (UNII: 151Z7P1317)  
HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
PECTIN (UNII: 89NA02M4RX)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
APPLE SEED OIL (UNII: 9ACA4K9013)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
C14-22 ALCOHOLS (UNII: B1K89384RJ)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
WATER (UNII: 059QF0KO0R)  
MICA (UNII: V8A1AW0880)  
BETAINE (UNII: 3SCV180C9W)  
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54181-005-301 in 1 BOX07/01/201601/01/2018
131.5 g in 1 TUBE; Type 0: Not a Combination Product
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/01/201601/01/2018
Labeler - GUINOT Institut Paris (763667185)
Registrant - GUINOT Institut Paris (763667185)
Establishment
NameAddressID/FEIBusiness Operations
GUINOT Institut Paris763667185manufacture(54181-005) , label(54181-005)

Revised: 12/2017
Document Id: 616ea9d5-1cfd-16e2-e053-2991aa0ab735
Set id: 289542c1-1345-3b43-e054-00144ff8d46c
Version: 3
Effective Time: 20171228
 
GUINOT Institut Paris