HOURGLASS EQUILIBRIUM DAY FLUID SPF 30- homosalate, octinoxate, ocitsalate, avobenzone lotion
Kingdom Animalia, LLC dba Hourglass Comsetics

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.

----------

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

Equilibrium carton

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42627-269
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:42627-269-01	1 in 1 CARTON	04/01/2015
1	NDC:42627-269-02	49.3 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product

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

Labeler - Kingdom Animalia, LLC dba Hourglass Comsetics (004924553)

Revised: 10/2022

Document Id: ec2040b6-d4a8-f841-e053-2995a90a3106

Set id: 8b7e213f-5436-4de8-ba93-d1dfd9d9da49

Version: 15

Effective Time: 20221031

Kingdom Animalia, LLC dba Hourglass Comsetics