EXUVIANCE SHEER REFINING FLUID SPF 35- octinoxate, octisalate, and avobenzone lotion

Exuviance Sheer Refining Fluid SPF 35 by

Drug Labeling and Warnings

Exuviance Sheer Refining Fluid SPF 35 by is a Otc medication manufactured, distributed, or labeled by NeoStrata Company Inc., Cosmetic Essence, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Ethylhexyl Methoxycinnamate (Octinoxate) 7.5%
Ethylhexyl Salicylate (Octisalate) 5.0%
Butyl Methoxydibenzoylmethane (Avobenzone) 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 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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply liberally to face and neck daily, 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 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

Inactive ingredients

Aqua (Water), Acetyl Glucosamine, Butyloctyl Salicylate, Cyclopentasiloxane, Glycerin, C12-C15 Alkyl Benzoate, Dimethicone, Butylene Glycol, Glyceryl Stearate, Octyldodecyl Neopentanoate, Cetyl Alcohol, PEG-100 Stearate, Cetearyl Alcohol, Tocopheryl (Vitamin E) Acetate, Melia Azadirachta Leaf Extract, Arctium Lappa Root Extract, Vitis Vinifera (Grape) Seed Extract, Lecithin, Dimethicone Crosspolymer, Propylene Glycol, PEG-75 Stearate, Xanthan Gum, Disodium EDTA, Ceteth-20, Steareth-20, Carbomer, Ammonium Hydroxide, Phenoxyethanol, Caprylyl Glycol, Chlorphenesin, Sodium Bisulfite

Other information

• Store at 15°C-30°C (59°F-86°F)
• Protect this product from excessive heat and direct sun

Questions or comments?

Call toll free 1-800-225-9411 (9am-5pm ET)

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

DERMATOLOGIST DEVELOPED
Exuviance®

Sheer Refining Fluid

oily / acne prone

with Sunscreen
Broad Spectrum SPF 35

Powerful antiaging benefits
for oily skin

Formulated to firm, smooth fine
lines and even skin tone

Controls oiliness

50 mL / 1.75 fl oz

INGREDIENTS AND APPEARANCE

EXUVIANCE SHEER REFINING FLUID SPF 35 
octinoxate, octisalate, and avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58414-2047
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	50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
N-ACETYLGLUCOSAMINE (UNII: V956696549)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
CETYL ALCOHOL (UNII: 936JST6JCN)
PEG-100 STEARATE (UNII: YD01N1999R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
AZADIRACHTA INDICA LEAF (UNII: HKY915780T)
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)
VITIS VINIFERA SEED (UNII: C34U15ICXA)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PEG-75 STEARATE (UNII: OT38R0N74H)
XANTHAN GUM (UNII: TTV12P4NEE)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CETETH-20 (UNII: I835H2IHHX)
STEARETH-20 (UNII: L0Q8IK9E08)
AMMONIA (UNII: 5138Q19F1X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
SODIUM BISULFITE (UNII: TZX5469Z6I)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER (UNII: RSA9I561OK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58414-2047-1	1 in 1 CARTON	07/02/2013	10/31/2021
1		50 mL in 1 BOTTLE, PUMP; 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	07/02/2013	10/31/2021

Labeler - NeoStrata Company Inc. (605754829)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Essence, LLC		825646862	MANUFACTURE(58414-2047)