NATURIUM UV REFLECT ANTIOXIDANT SPF 50- homosalate, octisalate, avobenzone lotion

Naturium UV Reflect Antioxidant SPF 50 by

Drug Labeling and Warnings

Naturium UV Reflect Antioxidant SPF 50 by is a Otc medication manufactured, distributed, or labeled by e.l.f. Cosmetics, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Avobenzone 3.0%

Homosalate 10.0%

Octisalate 5.0%

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

For sunscreen use:

• Shake well before use.
• Apply liberally and evenly 15 minutes before sun exposure.

Reapply:

• After 40 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours.
• Children under 6 months: ask a doctor.
• Sun Protection Measures: Spending time in the sun increases risk of skin cancer and early aging. To decrease this risk, regularly use a sunscreen with a Broad-Spectrum SPF value of 15 or higher and other sun protection measures including:
• Limit time in the sun, especially from 10:00 a.m. - 2:00 p.m.
• Wear long sleeved shirts, pants, hats, and sunglasses.
  

Other Information

• Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

Aqua/Water/Eau, Isododecane, Polymethyl Methacryate, Butyloctyl Salicylate, Acrylates Copolymer, Saccharomyces Ferment, Aluminum Starch Octenylsuccinate, Butylene Glycol, Polyglyceryl-6 Polyricinoleate, C24-28 Alkyldimethylsiloxy Trimethylsiloxysilicate, Polyglyceryl-2 Dipolyhydroxystearate, Disteardimonium Hectorite, Sodium Chloride, Caesalpinia Spinosa Fruit Extract, Helianthus Annuus (Sunflower) Sprout Extract, Sodium Stearoyl Glutamate, Glycine Soja (Soybean) Oil, Squalane, Raspberry Ketone, Lauroyl Lysine, Caprylyl/Capryl Glucoside, Triethyl Citrate, Polyglyceryl-10 Dioleate, Hydroxyethylcellulose, Octyldodecanol, Tocopherol, Sodium Phytate, Disodium Phosphate, Sodium Phosphate, Sodium Benzoate, Caprylyl Glycol, Propylene Glycol, Citric Acid, Phenoxyethanol.

Questions?

www.naturium.com

Product Packaging

INGREDIENTS AND APPEARANCE

NATURIUM UV REFLECT ANTIOXIDANT SPF 50 
homosalate, octisalate, avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-125
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
PHYTATE SODIUM (UNII: 88496G1ERL)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
SODIUM PHOSPHATE (UNII: SE337SVY37)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
SODIUM BENZOATE (UNII: OJ245FE5EU)
4-(P-HYDROXYPHENYL)-2-BUTANONE (UNII: 7QY1MH15BG)
SQUALANE (UNII: GW89575KF9)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ISODODECANE (UNII: A8289P68Y2)
SOYBEAN OIL (UNII: 241ATL177A)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
POLYGLYCERYL-10 DIOLEATE (UNII: 598RES7AXX)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
LAUROYL LYSINE (UNII: 113171Q70B)
TOCOPHEROL (UNII: R0ZB2556P8)
WATER (UNII: 059QF0KO0R)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
OCTYLDODECANOL (UNII: 461N1O614Y)
HELIANTHUS ANNUUS SPROUT (UNII: 4P26HG1S5W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76354-125-01	1 in 1 CARTON	04/10/2023
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/10/2023

Labeler - e.l.f. Cosmetics, Inc (093902816)