NATURIUM DEW GLOW TINTED MOISTURIZER SPF50-DEEP- homosalate, octisalate, avobenzone lotion NATURIUM DEW GLOW TINTED MOISTURIZER SPF50-MEDIUM- homosalate, octisalate, avobenzone lotion NATURIUM DEW GLOW TINTED MOISTURIZER SPF50-LIGHT- homosalate, octisalate, avobenzone lotion

Naturium Dew Glow Tinted Moisturizer SPF50-light by

Drug Labeling and Warnings

Naturium Dew Glow Tinted Moisturizer SPF50-light 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]

Drug Facts

ACTIVE INGREDIENT

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 signs of aging caused by the sun.

WARNINGS

For external use only.

on damaged or broken skin.

keep out of eyes. Rinse with water to remove.

if product is swallowed, get medical help 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 INGREDIENT

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

May Contain: Iron Oxide (CI 77491), Iron Oxide (CI 77492), Iron Oxide (CI 77499)

QUESTIONS

www.naturium.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NATURIUM DEW GLOW TINTED MOISTURIZER SPF50-DEEP 
homosalate, octisalate, avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59735-923
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 50 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
NIACINAMIDE (UNII: 25X51I8RD4)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
TOCOPHEROL (UNII: R0ZB2556P8)
3-O-ETHYL ASCORBIC ACID (UNII: 6MW60CB71P)
OCTADECENE (UNII: H5ZUQ6V4AK)
XANTHAN GUM (UNII: TTV12P4NEE)
POLYISOBUTYLENE (400000 MW) (UNII: X9N69O5R5X)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
BROWN IRON OXIDE (UNII: 1N032N7MFO)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HYALURONIC ACID (UNII: S270N0TRQY)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)
BOROSILICATE GLASS (UNII: BOJ6T9AR90)
ARGAN OIL (UNII: 4V59G5UW9X)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
SQUALANE (UNII: GW89575KF9)
SORBITAN OLIVATE (UNII: MDL271E3GR)
CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59735-923-02	1 in 1 CARTON	12/27/2023
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	12/27/2023

NATURIUM DEW GLOW TINTED MOISTURIZER SPF50-MEDIUM 
homosalate, octisalate, avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59735-921
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 50 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
NIACINAMIDE (UNII: 25X51I8RD4)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
TOCOPHEROL (UNII: R0ZB2556P8)
3-O-ETHYL ASCORBIC ACID (UNII: 6MW60CB71P)
OCTADECENE (UNII: H5ZUQ6V4AK)
XANTHAN GUM (UNII: TTV12P4NEE)
POLYISOBUTYLENE (400000 MW) (UNII: X9N69O5R5X)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
BROWN IRON OXIDE (UNII: 1N032N7MFO)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HYALURONIC ACID (UNII: S270N0TRQY)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)
BOROSILICATE GLASS (UNII: BOJ6T9AR90)
ARGAN OIL (UNII: 4V59G5UW9X)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
SQUALANE (UNII: GW89575KF9)
SORBITAN OLIVATE (UNII: MDL271E3GR)
CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59735-921-02	1 in 1 CARTON	12/27/2023
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	12/27/2023

NATURIUM DEW GLOW TINTED MOISTURIZER SPF50-LIGHT 
homosalate, octisalate, avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59735-922
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 50 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
NIACINAMIDE (UNII: 25X51I8RD4)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
TOCOPHEROL (UNII: R0ZB2556P8)
3-O-ETHYL ASCORBIC ACID (UNII: 6MW60CB71P)
OCTADECENE (UNII: H5ZUQ6V4AK)
XANTHAN GUM (UNII: TTV12P4NEE)
POLYISOBUTYLENE (400000 MW) (UNII: X9N69O5R5X)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
BROWN IRON OXIDE (UNII: 1N032N7MFO)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HYALURONIC ACID (UNII: S270N0TRQY)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)
BOROSILICATE GLASS (UNII: BOJ6T9AR90)
ARGAN OIL (UNII: 4V59G5UW9X)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
SQUALANE (UNII: GW89575KF9)
SORBITAN OLIVATE (UNII: MDL271E3GR)
CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59735-922-02	1 in 1 CARTON	12/27/2023
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	12/27/2023

Labeler - PML NYC, LLC (078870292)

Establishment
Name	Address	ID/FEI	Business Operations
PML NYC, LLC		078870292	manufacture(59735-921, 59735-922, 59735-923)