Label: HYDRA FINISH SPF 15- homosalate, octinoxate cream
- NDC Code(s): 54181-006-30
- Packager: Guinot
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 25, 2024
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients
- Uses
- Warnings
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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
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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: 54181-006-30
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INGREDIENTS AND APPEARANCE
HYDRA FINISH SPF 15
homosalate, octinoxate creamProduct 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 Drug M020 07/22/2016 Labeler - Guinot (763667185)
