Hydra Day SPF 20

Dosage form: cream
Ingredients: OCTINOXATE 7.5mL in 100mL, OCTISALATE 3.0mL in 100mL, OXYBENZONE 3.0mL in 100mL, TITANIUM DIOXIDE 0.4mL in 100mL
Labeler: 3LAB, Inc
NDC Code: 76159-123

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.

Hydra Day SPF 20

Active Ingredients                          Purpose
OCTINOXATE 7.5%......................Sunscreen
OCTISALATE 3.0%.......................Sunscreen
OXYBENZONE 3.0%....................Sunscreen
TITANIUM DIOXIDE 0.4%..............Sunscreen

Uses - Helps prevent sunburn. - Higher SPF gives more sunburn protection.

Warnings For external use only

Do not use on irritated or broken skin

Stop use and ask a physician if rash, irritation or sensitivity develops and lasts

When using this product do not get into eyes. If contact occurs, rinse eyes thoroughly with water.

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Directions - Apply to clean skin for daily sun protection - Allow to absorb - Ask a doctor before use on children under 3 years of age.

Other Information  Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreen may reduce the risks of skin aging, skin cancer and other harmful effects of the sun.

Inactive Ingredients Water (Aqua/Eau), Propylene Glycol, Glyceryl Stearate, Peg-100 Stearate, Stearic Acid, Caprylic/Capric Triglyceride, C12-15 Alkyl Benzoate, Glycerin, Dimethicone, Sodium Hyaluronate,  Cetyl Alcohol, Tocopheryl Acetate,  Panthenol,  Sodium PCA, Ceramide 2,  Retinyl Palmitate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Triethanolamine,  Alumina, Sodium Levulinate, Sodium Anisate, Citric Acid, Phenoxyethanol

Directions Apply to cleansed and toned skin A.M. after and 3LAB serum. Can be used throughout the day. Hydra Day SPF 20 Water-based Sunscreen  A multi-tasking moisturizer to guard against environment 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, protein-protective Phyllanthus Emblica Fruit Extract, and advanced moisturizers, acts as a superior anti-aging product, with broad-spectrum sunscreen protection. Light luminous, and quickly absorbed. Just Perfect.

Hydra Day SPF 20 Water-based Sunscreen

3LAB Hydra Day SPF 20 Water-based Sunscreen NET/WT. 2 OZ./58 mL e

HYDRA DAY SPF 20 
octinoxate, octisalate, oxybenzone, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76159-123
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE7.5 mL  in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE3.0 mL  in 100 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE3.0 mL  in 100 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE0.4 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
PROPYLENE GLYCOL 
GLYCERYL MONOSTEARATE 
PEG-100 STEARATE 
STEARIC ACID 
MEDIUM-CHAIN TRIGLYCERIDES 
ALKYL (C12-15) BENZOATE 
GLYCERIN 
DIMETHICONE 
HYALURONATE SODIUM 
CETYL ALCOHOL 
PANTHENOL 
SODIUM PYRROLIDONE CARBOXYLATE 
CERAMIDE 2 
VITAMIN A PALMITATE 
ALLANTOIN 
TROLAMINE 
ALUMINUM OXIDE 
SODIUM ANISATE 
CITRIC ACID MONOHYDRATE 
PHENOXYETHANOL 
Packaging
#Item CodePackage Description
1NDC:76159-123-0158 mL in 1 JAR
2NDC:76159-123-026 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/15/2011
Labeler - 3LAB, Inc (162333277)
Establishment
NameAddressID/FEIOperations
Englewood Lab, LLC172198223manufacture

Revised: 04/2011
 
3LAB, Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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