NATURIUM DEW-GLOW MOISTURIZER SPF 50- homosalate, octisalate, avobenzone lotion

Naturium Dew-Glow Moisturizer SPF 50 by

Drug Labeling and Warnings

Naturium Dew-Glow Moisturizer 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.

Keep out of reach of children.

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

Directions

For sunscreen use:

• Apply generously and evenly 15 minutes before sun exposure.
• Apply to all skin exposed to the sun.
• Use a water-resistant sunscreen if swimming or sweating.
• Reapply at least every 2 hours.
• 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.
• Children under 6 months of age: Ask a doctor.

Other Information

• Protect this product from excessive heat and direct sun.

Inactive Ingredients

Aqua/Water/Eau, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Calcium Sodium Borosilicate, Glycerin, Glyceryl Stearate, Ethylhexyl Methoxycrylene, VP/Eicosene Copolymer, Stearyl Dimethicone, Argania Spinosa Kernel Oil, Tocopheryl Acetate, 1,2-Hexandiol, Niacinamide, Sodium Stearoyl Glutamate, Tocopherol, Cetearyl Olivate, Bisabolol, 3-O-Ethyl Ascorbic Acid, Sodium Hyaluronate, Squalane, Ammonium Acryloyldimethyltaurate/VP Copolymer, Hydroxyacetophnone, Silica, Octadecene, Sorbitan Olivate, Sorbitan Oleate, Caprylyl/Capryl Glucoside, Xanthan Gum, Sodium Acrylate/Sodium Acryloyldimethyltaurate/VP Copolymer, Hydroxyacetophenone, Silica, Octadecene, Sorbitan Olivate, Sorbitan Oleate, Caprylyl/Capryl Glucoside, Xanthan Gum, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Trisodium Ethylenediamine Disuccinate, Polyisobutene, Citric Acid, Sodium Hydroxide.

Questions?

www.naturium.com

Product Packaging

INGREDIENTS AND APPEARANCE

NATURIUM DEW-GLOW MOISTURIZER SPF 50 
homosalate, octisalate, avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-130
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 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
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
POLYISOBUTYLENE (55000 MW) (UNII: TQ77WR8A02)
LEVOMENOL (UNII: 24WE03BX2T)
3-O-ETHYL ASCORBIC ACID (UNII: 6MW60CB71P)
NIACINAMIDE (UNII: 25X51I8RD4)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SORBITAN OLIVATE (UNII: MDL271E3GR)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
ARGAN OIL (UNII: 4V59G5UW9X)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
OCTADECENE (UNII: H5ZUQ6V4AK)
CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)
XANTHAN GUM (UNII: TTV12P4NEE)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
BOROSILICATE GLASS (UNII: BOJ6T9AR90)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SQUALANE (UNII: GW89575KF9)
TOCOPHEROL (UNII: R0ZB2556P8)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76354-130-01	1 in 1 CARTON	10/24/2022
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	10/24/2022

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