HYDRA FINISH SPF 15- homosalate, octinoxate cream

Hydra Finish SPF 15 by

Drug Labeling and Warnings

Hydra Finish 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

Homosalate 4.0%

Octinoxate 6.0%

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. – 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

Inactive ingredients

Water (Aqua), Titanium Dioxide (CI 77891), Cyclopentasiloxane, Ethylhexyl Stearate, Glycerin, C14- 22 Alcohols, Cyclohexasiloxane, Diethylhexyl 2,6-Naphthalate, Hydrogenated Coco-Glycerides, Propanediol, Microcrystalline Cellulose, Glyceryl Stearate Citrate, Pentylene Glycol, Iron Oxides (CI 77492), Propylene Glycol, Polyglyceryl-3 Stearate, Mica, Acrylates/Ammonium Methacrylate Copolymer, Isopropyl Myristate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, C12-20 Alkyl Glucoside, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Fragrance (Parfum), Hydrogenated Lecithin, Tocopheryl Acetate, Ethylhexylglycerin, Triethyl Citrate, Hexyldecanol, Silica, Iron Oxides (CI 77499), Iron Oxides (CI 77491), Cellulose Gum, Ceteareth-20, Triethanolamine, Betaine, Glyceryl Acrylate/Acrylic Acid Copolymer, Disodium EDTA, Pectin, Polysorbate 60, Sorbitan Isostearate, Sucrose, Butylene Glycol, Capryloyl Glycine, Sodium Hyaluronate, Red 33 (CI 17200), Malva Sylvestris (Mallow) Extract, Pyrus Malus (Apple) Seed Extract, Brassica Campestris (Rapeseed) Sterols, Tocopherol. 01

Package Labeling:

INGREDIENTS AND APPEARANCE

HYDRA FINISH SPF 15 
homosalate, octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54181-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	40 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	60 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
GLYCERIN (UNII: PDC6A3C0OX)
C14-22 ALCOHOLS (UNII: B1K89384RJ)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)
PROPANEDIOL (UNII: 5965N8W85T)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
MICA (UNII: V8A1AW0880)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
BEMOTRIZINOL (UNII: PWZ1720CBH)
C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
HEXYLDECANOL (UNII: 151Z7P1317)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
TROLAMINE (UNII: 9O3K93S3TK)
BETAINE (UNII: 3SCV180C9W)
PECTIN (UNII: 89NA02M4RX)
POLYSORBATE 60 (UNII: CAL22UVI4M)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
SUCROSE (UNII: C151H8M554)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
MALVA SYLVESTRIS FLOWERING TOP (UNII: X1U1U0N90J)
APPLE SEED (UNII: 33C88SEV0Z)
RAPESEED STEROL (UNII: B46B6DD20U)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54181-006-30	1 in 1 CARTON	07/22/2016
1		30 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	07/22/2016

Labeler - Guinot (763667185)