NATURIUM DEW-GLOW MOISTURIZER SPF 50- naturium dew-glow moisturizer spf 50 cream 
MANA Products, Inc

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.

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NATURIUM Dew-Glow Moisturizer SPF 50

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

Carton

NATURIUM DEW-GLOW MOISTURIZER SPF 50 
naturium dew-glow moisturizer spf 50 cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59735-338
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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)  
SQUALANE (UNII: GW89575KF9)  
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
ARGAN OIL (UNII: 4V59G5UW9X)  
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
OCTADECENE (UNII: H5ZUQ6V4AK)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
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)  
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)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59735-338-011 in 1 CARTON11/01/2022
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35211/01/2022
Labeler - MANA Products, Inc (078870292)
Establishment
NameAddressID/FEIBusiness Operations
MANA Products Inc078870292manufacture(59735-338)
Establishment
NameAddressID/FEIBusiness Operations
MANA Products, Inc032870270manufacture(59735-338)

Revised: 7/2023
 
MANA Products, Inc