HYDRA BEAUTE SPF 15- avobenzone, homosalate, octinoxate, octisalate, octocrylene cream 
Guinot

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HYDRA BEAUTE CREAM SPF 15

Drug Facts

Active ingredients

Avobenzone 2.85%

Homosalate 5.00%

Octinoxate 7.00%

Octisalate 3.00%

Octocrylene 9.00%

Purpose

Sunscreen

Uses

Warnings

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

- Limit time in the sun, especially from 10 a.m. to 2 p.m.

- Wear long-sleeve shirts, pants hats, and sunglasses.

Other information

Inactive ingredients

Water/Eau (Aqua), Glycerin, Cetyl Alcohol, Caprylic/Capric Triglyceride, Pentylene Glycol, Sodium Stearoyl Glutamate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polymethylsilsesquioxane, Caprylyl Methicone, HDI/Trimethylol Hexyllactone Crosspolymer, Hydrogenated Lecithin, Palmitic Acid, Propylene Glycol, Ethylhexylglycerin, Bisabolol, Oxidized Corn Oil, Tocopheryl Acetate, Stearalkonium Hectorite, Fragrance (Parfum), Xanthan Gum, C30-45 Alkyl Cetearyl Diemthicone Crossspolymer, Betaine, Propylene Carbonate, Polysorbate 60, Sorbitan Isostearate, Disodium EDTA, Laminaria Ochroleuca Extract, Pectin, Butylene Glycol, Sucrose, Glyceryl Acrylate/Acrylic Acid Copolymer, Capryloyl Glycine, Sodium Hyaluronate, Red 4 (CI 14700). 01

Package Labeling:

Outer PackageInner Package

HYDRA BEAUTE SPF 15 
avobenzone, homosalate, octinoxate, octisalate, octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54181-009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE28.5 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE50 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE70 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE30 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE90 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
PALMITIC ACID (UNII: 2V16EO95H1)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
LEVOMENOL (UNII: 24WE03BX2T)  
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
XANTHAN GUM (UNII: TTV12P4NEE)  
BETAINE (UNII: 3SCV180C9W)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
PECTIN (UNII: 89NA02M4RX)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
SUCROSE (UNII: C151H8M554)  
CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54181-009-501 in 1 BOX01/01/2019
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/01/2019
Labeler - Guinot (763667185)
Establishment
NameAddressID/FEIBusiness Operations
Guinot763667185manufacture(54181-009)

Revised: 10/2023
Document Id: 0814f3c4-26ed-6b31-e063-6294a90a4877
Set id: 806d1e18-a3fc-43df-a52a-a640902d0887
Version: 4
Effective Time: 20231019
 
Guinot