Label: AQUA PROTECTION SUNSCREEN BROAD SPECTRUM SPF50- avobenzone, homosalate, octisalate, octocrylene lotion
- NDC Code(s): 14268-122-01
- Packager: ENGLEWOOD LAB, INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 12, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients
- Uses
- Warnings
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Directions
- Apply liberally to all exposed skin 15 minutes before sun exposure.
- Reapply at least evey 2 hours.
- Use a water-resistant sunscreen if swimming or sweating:
- Children under 6 months of age: Ask a doctor.
- Spending time in the sun increases your risk of skin cancer and early aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Sun Protection Measures.
- Limit time in the sun, especially from 10 a.m. - 2 p.m. Wear long-sleeved shirts, pants, hats, and sunglasses.
- Othe information
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Inactive ingredients
Water (Aqua), Dipropylene Glycol, Methyl Methacrylate Crosspolymer, Glyceryl Polymethacrylate, Propylene Glycol, Butyloctyl Salicylate, Ceteareth-20, Ethylhexyl Methoxycrylene, Acrylates Copolymer, Polysorbate 60, Sorbitan Stearate, Caprylyl Glycol, Cetearyl Olivate, Panthenol, Sorbitan Olivate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ethylhexylglycerin, Tromethamine, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, 1,2-Hexanediol, Isohexadecane, Ammonium Acryloyldimethyltaurate/Vp Copolymer, Musa Sapientum Flower Extract, Rosa Damascena Flower Water, Pyrus Communis (Pear) Fruit Extract, Bht, Prunus Domestica Fruit Extract, Polysorbate 80, Cucumis Melo (Melon) Fruit Extract, Trisodium Ethylenediamine Disuccinate, Hedera Helix (Ivy) Leaf/Stem Extract, Xanthan Gum, Butylene Glycol, Glucosylrutin, Equisetum Arvense Extract, Lycopodium Clavatum Extract, Sodium Hyaluronate, Polyglutamic Acid, Hyaluronic Acid, Hydrolyzed Hyaluronic Acid, Hydrolyzed Sodium Hyaluronate, Hydroxypropyltrimonium Hyaluronate, Potassium Hyaluronate, Sodium Hyaluronate Crosspolymer, Betula Platyphylla Japonica Juice, Pentylene Glycol
- Package Labeling:
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INGREDIENTS AND APPEARANCE
AQUA PROTECTION SUNSCREEN BROAD SPECTRUM SPF50
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14268-122 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 90 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 45 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength DIPROPYLENE GLYCOL (UNII: E107L85C40) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) POLYSORBATE 60 (UNII: CAL22UVI4M) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CETEARYL OLIVATE (UNII: 58B69Q84JO) PANTHENOL (UNII: WV9CM0O67Z) SORBITAN OLIVATE (UNII: MDL271E3GR) WATER (UNII: 059QF0KO0R) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) TROMETHAMINE (UNII: 023C2WHX2V) SODIUM ACRYLATE (UNII: 7C98FKB43H) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) ISOHEXADECANE (UNII: 918X1OUF1E) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) ROSA X DAMASCENA FLOWER OIL (UNII: 18920M3T13) PEAR (UNII: 2ZN8DWC0YF) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) OCTYLDODECANOL (UNII: 461N1O614Y) PLUM (UNII: 67M3EQ6BE1) POLYSORBATE 80 (UNII: 6OZP39ZG8H) MUSKMELON (UNII: ZV095H5633) TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) HEDERA HELIX LEAF (UNII: ZP9XFG71A7) XANTHAN GUM (UNII: TTV12P4NEE) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E) HYALURONATE SODIUM (UNII: YSE9PPT4TH) HYALURONIC ACID (UNII: S270N0TRQY) BETULA PLATYPHYLLA RESIN (UNII: 1B33PG6N4K) PENTYLENE GLYCOL (UNII: 50C1307PZG) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14268-122-01 50 mL in 1 TUBE; Type 0: Not a Combination Product 03/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 03/01/2023 Labeler - ENGLEWOOD LAB, INC. (172198223)
