3LAB HYDRA DAY SPF 20 BROAD SPECTRUM WATER-BASED SUNSCREEN- octinoxate, octisalate, avobenzone cream

3LAB Hydra Day SPF 20 Broad Spectrum Water-Based Sunscreen by

Drug Labeling and Warnings

3LAB Hydra Day SPF 20 Broad Spectrum Water-Based Sunscreen by is a Otc medication manufactured, distributed, or labeled by 3LAB, Inc, Englewood Lab, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Octinoxate 7.5%
Octisalate 4.6%
Avobenzone 2.0%

Purpose

Sunscreen

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

For external use only.

Do not use

on damaged or broken skin.

When using this product

keep out of eyes.  Rinse with water to remove.

Stop use and ask a doctor

if rash occurs.

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

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

Protect this product from excessive heat and direct sun

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

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

3LAB  Hydra Day SPF 20 BROAD SPECTRUM  Water-based Sunscreen     NET WT. 2 OZ. / 60 mL e

Product Label

INGREDIENTS AND APPEARANCE

3LAB HYDRA DAY SPF 20 BROAD SPECTRUM WATER-BASED SUNSCREEN  
octinoxate, octisalate, avobenzone cream

Product 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.		080366903	manufacture(76159-124)

Establishment
Name	Address	ID/FEI	Business Operations
Englewood Lab Korea Co., Ltd.		690104005	manufacture(76159-124)