Label: DEFEND HYDRATING BROAD SPECTRUM SPF 15- spf 15 sunscreen cream
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Contains inactivated NDC Code(s)
NDC Code(s): 70384-100-01 - Packager: Profile 4 Men LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated April 18, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients:
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SPL UNCLASSIFIED SECTION
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:
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Directions:
- Apply to neck and face before exposure to the sun and the light of day.
- Apply liberally 15 minutes before sun exposure.
- Use a water resistant sunscreen if swimming or sweating, reapply at least every two hours.
- Children under 6 months. Ask a doctor.
USE ONLY AS DIRECTED.
Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularaly use a sunscreen with a Broad Spectrum value of SPF 15 or higher and other sun protection measures including:
- Limit time in the sun, especially from 10 a.m.-2p.m.
- Wear long-sleeved shirts, pants, hats and sunglasses
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Inactive Ingredients
Water/Aqua/Eau, Silica, Caprylic/Capric Triglyceride, Glycerin, Xylitylglucoside, Anhydroxylitol, Xylitol, Chondrus Crispus Extract, Sodium Hyaluronate, Glyceryl Stearate, Butyrospermum Parkii (Shea) Butter, Cetearyl Alcohol, Tocopheryl Acetate, Ilex Paraguariensis Leaf Extract, Avena Sativa (Oat) Kernel Extract, Vegetable Collagen, Stearic Acid, Polymethyl Methacrylate, Di-C12-15 Alkyl Fumarate, Cetyl Phosphate, Disodium EDTA, Carbomer, Fragrance, Aminomethyl Propanol, Phenoxyethanol, Caprylyl Glycol, Potassium Sorbate, Hexylene Glycol
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DEFEND HYDRATING BROAD SPECTRUM SPF 15
spf 15 sunscreen creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70384-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 6 mg in 75 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.25 mg in 75 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 3.75 mg in 75 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9) GLYCERIN (UNII: PDC6A3C0OX) XYLITYLGLUCOSIDE (UNII: O0IEZ166FB) ANHYDROXYLITOL (UNII: 8XWR7NN42F) XYLITOL (UNII: VCQ006KQ1E) CHONDRUS CRISPUS (UNII: OQS23HUA1X) POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) SHEA BUTTER (UNII: K49155WL9Y) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F) AVENA SATIVA WHOLE (UNII: 5P8D0Z74RG) SOY PROTEIN (UNII: R44IWB3RN5) STEARIC ACID (UNII: 4ELV7Z65AP) METHACRYLATE/METHOXY PEG-10 MALEATE/STYRENE COPOLYMER (UNII: 39DK5WQ2PR) DI-C12-15 ALKYL FUMARATE (UNII: A1CB3Z898P) CETYL PHOSPHATE (UNII: VT07D6X67O) EDETIC ACID (UNII: 9G34HU7RV0) CARBOMER 934 (UNII: Z135WT9208) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) HEXYLENE GLYCOL (UNII: KEH0A3F75J) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70384-100-01 1 in 1 PACKAGE 04/07/2016 1 75 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 final part352 04/07/2016 Labeler - Profile 4 Men LLC (080080227) Establishment Name Address ID/FEI Business Operations PhytogenX, Inc. 624386772 manufacture(70384-100)
