MARCELLE CITY TINTED CREAM SPF 25 OCTINOXATE SUNSCREEN- octinoxate cream

Marcelle City Tinted Cream SPF 25 Octinoxate Sunscreen by

Drug Labeling and Warnings

Marcelle City Tinted Cream SPF 25 Octinoxate Sunscreen by is a Otc medication manufactured, distributed, or labeled by Groupe Marcelle Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

PURPOSE

Active Ingredient               Purpose

Octinoxate 7.5%                   Sunscreen

Uses

• Helps prevent sunburn.

Warnings

For external use only.

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

DO NOT USE

Do not use on damaged or broken skin.

WHEN USING

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

STOP USE

Stop use and ask a doctor if  rash occurs.

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
• Reapply at least every 2 hours
• Use a water resistant sunscreen if swimming or sweating:

      - immediately after towel drying

      - at least every 2 hours

• Children under 6 months of age: ask a doctor

Inactive ingredients

AQUA/WATER/EAU, CYCLOPENTASILOXANE, OCTYLDODECANOL, GLYCERIN, CYCLOHEXASILOXANE, DIMETHICONE, POLYMETHYLSILSESQUIOXANE, MICA, BIS-PEG/ PPG-14/14 DIMETHICONE, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, ISOPROPYL MYRISTATE, POLYGLYCERYL-4 ISOSTEARATE, HEXYL LAURATE, CETYL PEG/PPG-10/1 DIMETHICONE, ILLITE, SODIUM CHLORIDE, POLY(GLYCOL ADIPATE)/BIS-HYDROXYETHOXYPROPYL DIMETHICONE COPOLYMER, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, TALC, PROPYLENE GLYCOL,
DIMETHICONE CROSSPOLYMER, ISODODECANE, DISTEARDIMONIUM HECTORITE, BIOSACCHARIDE GUM-1, TRIHYDROXYSTEARIN, DIAZOLIDINYL UREA, ACRYLATES/ DIMETHICONE COPOLYMER, SODIUM BENZOATE, POTASSIUM SORBATE, PROPYLENE CARBONATE, TOCOPHERYL ACETATE, BUTYROSPERMUM PARKII (SHEA) SEEDCAKE EXTRACT, LENS ESCULENTA (LENTIL) SEED EXTRACT, COLLOIDAL PLATINUM, HYDROLYZED WHEAT PROTEIN, ISOCETETH-10, BUTYLENE GLYCOL, TRIETHOXYCAPRYLYLSILANE, CAMELLIA OLEIFERA LEAF EXTRACT, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, ALOE BARBADENSIS LEAF JUICE, ETHYLHEXYLGLYCERIN, IODOPROPYNYL BUTYLCARBAMATE, PHENOXYETHANOL, CITRIC ACID. +/- TITANIUM DIOXIDE, IRON OXIDES.

Other information

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

Principal Display Panel - 7 mL 0.23 Fl. Oz.

Marcelle® City Tinted Cream SPF 25 Octinoxate Sunscreen

Principal Display Panel - 30 mL 1 Fl. Oz.

Marcelle® City Tinted Cream SPF 25 Octinoxate Sunscreen

INGREDIENTS AND APPEARANCE

MARCELLE CITY TINTED CREAM SPF 25 OCTINOXATE SUNSCREEN 
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69922-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.525 g  in 7 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
OCTYLDODECANOL (UNII: 461N1O614Y)
GLYCERIN (UNII: PDC6A3C0OX)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
MICA (UNII: V8A1AW0880)
BIS-PEG/PPG-14/14 DIMETHICONE (UNII: X2I70H0QJE)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
LEDIKITE (UNII: D7BC5B0F46)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
TALC (UNII: 7SEV7J4R1U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
ISODODECANE (UNII: A8289P68Y2)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LENTIL (UNII: 6O38V6B52O)
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)
ISOCETETH-10 (UNII: 1K92T9919H)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
CHAMOMILE (UNII: FGL3685T2X)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERROUS OXIDE (UNII: G7036X8B5H)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69922-002-02	1 in 1 CARTON	06/01/2017
1		7 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 69922-002-01	1 in 1 CARTON	06/05/2017
2		30 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 not final	part352	06/01/2017

Labeler - Groupe Marcelle Inc. (202309647)