HYDRA DAY SPF 20- octinoxate, octisalate, oxybenzone and titanium dioxide cream 
3LAB, Inc

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.

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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

Englewood Lab LLC Hydra Day Outer 1

Englewood Lab LLC Hydra Day Outer

HYDRA DAY SPF 20 
octinoxate, octisalate, oxybenzone, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:76159-123
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE75 mg  in 1 mL
OCTISALATE (OCTISALATE) OCTISALATE30 mg  in 1 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE30 mg  in 1 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE4 mg  in 1 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 DescriptionMarketing Start DateMarketing End Date
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 finalpart35204/15/201103/05/2014
Labeler - 3LAB, Inc (162333277)
Establishment
NameAddressID/FEIBusiness Operations
Englewood Lab, LLC172198223manufacture(76159-123)

Revised: 3/2014
 
3LAB, Inc