NDC | 76159-124-01, 76159-124-02 |
Set ID | d539b851-c4b2-40a2-9562-e3a95a86b744 |
Category | HUMAN OTC DRUG LABEL |
Packager | 3LAB, Inc |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- Drug Facts
- Active Ingredients
- Purpose
- Uses
- Warnings
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Directions
- Apply liberally 15 minutes before sun exposure
- Reapply
- After 40 minutes of swimming or sweating
- Immediately after towel drying
- At least every 2 hours
- 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/Eau), Propylene Glycol, Glyceryl Sterate, PEG-100 Stearate, Caprylic/Capric triglyceride, STearic Acid, Cetyl Alcohol, Dimethicone, Sodium Hyaluronate, Tocopheryl Acetate, Allantoin, Panthenol, Sodium PCA, Ceramide 2, Acrylates/C-10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Disodium EDTA, Phenoxyethanol, Caprylyl Glycol, Chlorphenesin
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Hydra Day SPF 20
Water-based Sunscreen
A multi-tasking moisturizer to guard against environmental damage. Provide luxurious hydration, and give skin a silky finish for flawless makeup application. Fortified with 3LAB's exclusive proprietary complex. a synergistic blend of powerful natural polyphenol antioxidants, and advanced moisturizers: it acts as a superior anti-aging product, with broad-spectrum sunscreen protection. Light, luminous and quickly absorbed. Just Perfect!
- PRINCIPAL DISPLAY PANEL
- Product Label
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INGREDIENTS AND APPEARANCE
3LAB HYDRA DAY SPF 20 BROAD SPECTRUM WATER-BASED SUNSCREEN
octinoxate, octisalate, avobenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76159-124 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 46 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2 mg in 1 mL Inactive Ingredients Ingredient Name Strength PEG-100 STEARATE (UNII: YD01N1999R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) STEARIC ACID (UNII: 4ELV7Z65AP) CETYL ALCOHOL (UNII: 936JST6JCN) DIMETHICONE (UNII: 92RU3N3Y1O) HYALURONATE SODIUM (UNII: YSE9PPT4TH) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ALLANTOIN (UNII: 344S277G0Z) PANTHENOL (UNII: WV9CM0O67Z) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) CERAMIDE 2 (UNII: C04977SRJ5) TROLAMINE (UNII: 9O3K93S3TK) EDETATE DISODIUM (UNII: 7FLD91C86K) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CHLORPHENESIN (UNII: I670DAL4SZ) WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76159-124-01 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/19/2017 2 NDC:76159-124-02 6 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/19/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 10/15/2012 Labeler - 3LAB, Inc (162333277) Establishment Name Address ID/FEI Business Operations Englewood Lab, Inc. 080987545 manufacture(76159-124) Establishment Name Address ID/FEI Business Operations Englewood Lab Korea Co., Ltd. 690104005 manufacture(76159-124)