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

HYDRA BEAUTE SPF 15 by

Drug Labeling and Warnings

HYDRA BEAUTE SPF 15 by is a Otc medication manufactured, distributed, or labeled by Guinot. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Avobenzone 2.85%

Homosalate 5.00%

Octinoxate 7.00%

Octisalate 3.00%

Octocrylene 9.00%

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 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. to 2 p.m.

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

• Children under 6 months: Ask a doctor.

Other information

• Protect this product from excessive heat and direct sun.
• Store below 30°C/86°F.

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:

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54181-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	28.5 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	50 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	70 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	30 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	90 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ALCOHOL (UNII: 936JST6JCN)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54181-009-50	1 in 1 BOX	01/01/2019
1		50 mL in 1 TUBE; 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	01/01/2019

Labeler - Guinot (763667185)

Establishment
Name	Address	ID/FEI	Business Operations
Guinot		763667185	manufacture(54181-009)