NATURIUM DEW-GLOW MOISTURIZER SPF 50 cream

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 MANA Products, Inc, MANA Products Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

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. Stop use and ask doctor if rash occurs.

Warnings-When using

When using this product keep out of eyes. Rinse with water to remove.

Keep out of reach of children

Keep out of reach of children. If 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, 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.

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-Hexanediol, Niacinamide, Tocopherol, Cetearyl Olivate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Hydroxyacetophenone, Silica, Sodium Stearoyl Glutamate, Octadecene, Sorbitan Olivate, Xanthan Gum, Bisabolol, 3-o-ethyl ascorbic acid, Sodium Hyaluronate, Squalane, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Trisodium Ethylenediamine Disuccinate, Polyisobutene, Citric Acid, Sodium Hydroxide, Sorbitan Oleate, Caprylyl/Capryl Glucoside.

Other Information

Protect this product from excessive heat and direct sun.

Principle Display Panel

INGREDIENTS AND APPEARANCE

NATURIUM DEW-GLOW MOISTURIZER SPF 50 
naturium dew-glow moisturizer spf 50 cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59735-338
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
EICOSYL POVIDONE (UNII: XQQ9MKE2BJ)
STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POLYISOBUTYLENE (65000 MW) (UNII: VC9JLP352J)
CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
SORBITAN OLIVATE (UNII: MDL271E3GR)
ARGAN OIL (UNII: 4V59G5UW9X)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
SQUALANE (UNII: GW89575KF9)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
OCTADECENE (UNII: H5ZUQ6V4AK)
XANTHAN GUM (UNII: TTV12P4NEE)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
3-O-ETHYL ASCORBIC ACID (UNII: 6MW60CB71P)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
NIACINAMIDE (UNII: 25X51I8RD4)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59735-338-01	1 in 1 CARTON	11/01/2022
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 59735-338-04	1 in 1 CARTON	11/01/2022
2	NDC: 59735-338-03	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	11/01/2022

Labeler - MANA Products, Inc (078870292)

Establishment
Name	Address	ID/FEI	Business Operations
MANA Products, Inc		032870270	manufacture(59735-338)

Establishment
Name	Address	ID/FEI	Business Operations
MANA Products Inc		078870292	manufacture(59735-338)