Hourglass Equilibrium Day Fluid SPF30

Hourglass Equilibrium Day Fluid by

Drug Labeling and Warnings

Hourglass Equilibrium Day Fluid by is a Otc medication manufactured, distributed, or labeled by Northwest Cosmetic Laboratories LLC, DBA Elevation Labs, Idaho. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HOURGLASS EQUILIBRIUM DAY FLUID SPF 30- homosalate, octinoxate, ocitsalate, avobenzone lotion 
Northwest Cosmetic Laboratories LLC, DBA Elevation Labs, Idaho

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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Hourglass Equilibrium Day Fluid SPF30

Active Ingredients

Avobenzone    2.0%

Homosalate    9.9%

Octinoxate     7.5%

Octisalate      3.0%

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 damamged 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.
• Use a water resistant sunscreen if swimming or sweating.
• Reapply 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 include
• 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.

Inactive Ingredients

C12-15 ALKYL BENZOATE, CAPRYLYL GLYCOL, CETYL HYDROXYETHYLCELLULOSE, CHLORPHENESIN, CITRIC ACID, COCO-CAPRYLATE/CAPRATE, COCONUT ALKANES, DISODIUM EDTA, GLYCERIN, GLYCERYL COCOATE, PHENOXYETHANOL, PHOSPHATITYL GLYCEROL, POLYGLYCERYL-10 MONO/DIOLEATE, POLYGLYCERYL-3 OLEATE, TOCOHPERYL ACETATE, WATER XANTHAN GUM.

Other Information

Protect this product from excessive heat and direct sun.

Questions or comments?

Call toll free 855-201-4529

HOURGLASS EQUILIBRIUM DAY FLUID  SPF 30
homosalate, octinoxate, ocitsalate, avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62282-500
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	9.9 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	3 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)
GLYCERIN (UNII: PDC6A3C0OX)
XANTHAN GUM (UNII: TTV12P4NEE)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POLYGLYCERYL-10 OLEATE (UNII: 55C81W76DH)
POLYGLYCERYL-3 OLEATE (UNII: XRQ165498B)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
COCONUT ALKANES (UNII: 1E5KJY107T)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERYL COCOATE (UNII: WVK1CT5994)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62282-500-01	1 in 1 CARTON	04/01/2015
1	NDC: 62282-500-02	49.3 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/01/2015

Labeler - Northwest Cosmetic Laboratories LLC, DBA Elevation Labs, Idaho (929572014)

Revised: 12/2022

Document Id: eecaba03-cb4a-7135-e053-2995a90a8ef2

34390-5

Set id: eecabf30-2b5d-7f3c-e053-2995a90aa62b

Version: 1

Effective Time: 20221201

 

Northwest Cosmetic Lab