CLARITE MAKEUP FOUNDATION FOR A CLEARER APPEARANCE SPF 30 170-N- octinoxate, zinc oxide paste CLARITE MAKEUP FOUNDATION FOR A C

United States - English - NLM (National Library of Medicine)

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Active ingredient:
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)
Available from:
Ventura Corporation LTD
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Uses - Helps prevent sunburn Stop use and ask a doctor if rash occurs.
Authorization status:
OTC monograph final
Authorization number:
43596-0183-1, 43596-0184-1, 43596-0185-1, 43596-0186-1, 43596-0187-1, 43596-0188-1

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CLARITE MAKEUP FOUNDATION FOR A CLEARER APPEARANCE SPF 30 170-N-

octinoxate, zinc oxide paste

CLARITE MAKEUP FOUNDATION FOR A CLEARER APPEARANCE SPF 30 180-F-

octinoxate, zinc oxide paste

CLARITE MAKEUP FOUNDATION FOR A CLEARER APPEARANCE SPF 30 220-C-

octinoxate, zinc oxide paste

CLARITE MAKEUP FOUNDATION FOR A CLEARER APPEARANCE SPF 30 230-N-

octinoxate, zinc oxide paste

CLARITE MAKEUP FOUNDATION FOR A CLEARER APPEARANCE SPF 30 310-C-

octinoxate, zinc oxide paste

CLARITE MAKEUP FOUNDATION FOR A CLEARER APPEARANCE SPF 30 390-N-

octinoxate, zinc oxide paste

Ventura Corporation LTD

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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Clarite Makeup Foundation for a Clearer Appearance SPF 30

Active Ingredients Purpose

Octinoxate 7.50% Sunscreen

Zinc Oxide 7.84% Sunscreen

Uses

Helps prevent sunburn

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right

away

Stop use and ask a doctor if rash occurs.

Warnings:

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.

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.

Directions:

Apply Liberally and evenly 15 minutes before sun exposure

Reapply at least every 2 hours

Use a water resistant sunscreen if swimming or sweating

Children under six months of age: Ask a doctor

Other information:

Protect the product in this container from excessive hear and direct sun

Inactive ingredients: Dimethicone, mica, dicaprylyl carbonate, zea mays (corn) starch, ozokerite,

polyethylene, cetyl diglyceryl tris(trimethylsiloxy)silylethyl dimethicone, silica dimethyl silylate,

copernicia cerifera (carnauba) wax, kojic dipalmitate, cetyl peg/ppg-10/1 dimethicone, polyglyceryl-4

isostearate, hexyl laurate, phenoxyethanol, disteardimonium hectorite, triethoxycaprylylsilane, caprylyl

glycol, chlorphenesin, fragrance, glycyrrhiza glabra (licorice) root extract, trimethylsiloxysilicate,

dimethylmethoxy chromanyl palmitate, butylphenyl methylpropional, citronellol, hydroxycitronellal,

hexyl cinnamal, limonene, alpha-isomethyl ionone.

may contain: titanium dioxide, iron oxides.

170-N

L'Bel CLARITE

Base de maquillaje para una apariencia mas clara FPS 30

Makeup foundation for a clearer appearance SPF 30 170-N

Net Wt. 0.31 oz. e (9g)

180-F

L'Bel CLARITE

Base de maquillaje para una apariencia mas clara FPS 30

Makeup foundation for a clearer appearance SPF 30 180-F

Net Wt. 0.31 oz. e (9g)

220-C

L'Bel CLARITE

Base de maquillaje para una apariencia mas clara FPS 30

Makeup foundation for a clearer appearance SPF 30 220-C

Net Wt. 0.31 oz. e (9g)

230-N

L'Bel CLARITE

Base de maquillaje para una apariencia mas clara FPS 30

Makeup foundation for a clearer appearance SPF 30 230-N

Net Wt. 0.31 oz. e (9g)

310-C

L'Bel CLARITE

Base de maquillaje para una apariencia mas clara FPS 30

Makeup foundation for a clearer appearance SPF 30 310-C

Net Wt. 0.31 oz. e (9g)

390-N

L'Bel CLARITE

Base de maquillaje para una apariencia mas clara FPS 30

Makeup foundation for a clearer appearance SPF 30 390-N

Net Wt. 0.31 oz. e (9g)

CLARITE MAKEUP FOUNDATION FOR A CLEARER APPEARANCE SPF 30

170-N

octinoxate, zinc oxide paste

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:4359 6 -0 18 3

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

OCTINOXATE

7.5 g in 10 0 g

ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)

ZINC OXIDE

7.8 4 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

ISO METHYL-.ALPHA.-IO NO NE (UNII: 9 XP4LC555B)

HIGH DENSITY PO LYETHYLENE (UNII: UG0 0 KM4WR7)

PO LYGLYCERYL-4 ISO STEARATE (UNII: 8 20 DPX33S7)

TRIETHO XYCAPRYLYLSILANE (UNII: LDC331P0 8 E)

DISTEARDIMO NIUM HECTO RITE (UNII: X6 8 7XDK0 9 L)

CHLO RPHENESIN (UNII: I6 70 DAL4SZ)

BUTYLPHENYL METHYLPRO PIO NAL (UNII: T7540 GJV6 9 )

HYDRO XYCITRO NELLAL (UNII: 8 SQ0 VA4YUR)

CETYL PEG/PPG-10 /1 DIMETHICO NE ( HLB 2 ) (UNII: V2W71V8 T0 X)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

.BETA.-CITRO NELLO L, ( R) - (UNII: P0 1OUT9 6 4K)

TRIMETHYLSILO XYSILICATE ( M/Q 0 .8 -1.0 ) (UNII: 25LXE46 4L2)

.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6 O37OK2I)

LIMO NENE, ( +/-) - (UNII: 9 MC3I34447)

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

MICA (UNII: V8 A1AW0 8 8 0 )

DICAPRYLYL CARBO NATE (UNII: 6 0 9 A3V1SUA)

STARCH, CO RN (UNII: O8 232NY3SJ)

CERESIN (UNII: Q1LS2UJO3A)

SILICA DIMETHYL SILYLATE (UNII: EU2PSP0 G0 W)

CARNAUBA WAX (UNII: R12CBM0 EIZ)

KO JIC DIPALMITATE (UNII: 13N249 RWTM)

HEXYL LAURATE (UNII: 4CG9 F9 W0 1Q)

CAPRYLYL GLYCO L (UNII: 0 0 YIU5438 U)

GLYCYRRHIZA GLABRA (UNII: 278 8 Z9 758 H)

DIMETHYLMETHO XY CHRO MANYL PALMITATE (UNII: 5G222ZDK7U)

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

FERRO SO FERRIC O XIDE (UNII: XM0 M8 7F357)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:4359 6 -0 18 3-1

9 g in 1 CASE; Type 0 : No t a Co mbinatio n Pro duct

11/0 9 /20 20

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt352

11/0 9 /20 20

CLARITE MAKEUP FOUNDATION FOR A CLEARER APPEARANCE SPF 30

180-F

octinoxate, zinc oxide paste

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:4359 6 -0 18 4

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

OCTINOXATE

7.5 g in 10 0 g

ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)

ZINC OXIDE

7.8 4 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

ISO METHYL-.ALPHA.-IO NO NE (UNII: 9 XP4LC555B)

HIGH DENSITY PO LYETHYLENE (UNII: UG0 0 KM4WR7)

PO LYGLYCERYL-4 ISO STEARATE (UNII: 8 20 DPX33S7)

TRIETHO XYCAPRYLYLSILANE (UNII: LDC331P0 8 E)

DISTEARDIMO NIUM HECTO RITE (UNII: X6 8 7XDK0 9 L)

CHLO RPHENESIN (UNII: I6 70 DAL4SZ)

BUTYLPHENYL METHYLPRO PIO NAL (UNII: T7540 GJV6 9 )

HYDRO XYCITRO NELLAL (UNII: 8 SQ0 VA4YUR)

CETYL PEG/PPG-10 /1 DIMETHICO NE ( HLB 2 ) (UNII: V2W71V8 T0 X)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

.BETA.-CITRO NELLO L, ( R) - (UNII: P0 1OUT9 6 4K)

TRIMETHYLSILO XYSILICATE ( M/Q 0 .8 -1.0 ) (UNII: 25LXE46 4L2)

.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6 O37OK2I)

LIMO NENE, ( +/-) - (UNII: 9 MC3I34447)

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

MICA (UNII: V8 A1AW0 8 8 0 )

DICAPRYLYL CARBO NATE (UNII: 6 0 9 A3V1SUA)

STARCH, CO RN (UNII: O8 232NY3SJ)

CERESIN (UNII: Q1LS2UJO3A)

SILICA DIMETHYL SILYLATE (UNII: EU2PSP0 G0 W)

CARNAUBA WAX (UNII: R12CBM0 EIZ)

KO JIC DIPALMITATE (UNII: 13N249 RWTM)

HEXYL LAURATE (UNII: 4CG9 F9 W0 1Q)

CAPRYLYL GLYCO L (UNII: 0 0 YIU5438 U)

GLYCYRRHIZA GLABRA (UNII: 278 8 Z9 758 H)

DIMETHYLMETHO XY CHRO MANYL PALMITATE (UNII: 5G222ZDK7U)

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

FERRO SO FERRIC O XIDE (UNII: XM0 M8 7F357)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:4359 6 -0 18 4-1

9 g in 1 CASE; Type 0 : No t a Co mbinatio n Pro duct

11/0 9 /20 20

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt352

11/0 9 /20 20

CLARITE MAKEUP FOUNDATION FOR A CLEARER APPEARANCE SPF 30

220-C

octinoxate, zinc oxide paste

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:4359 6 -0 18 5

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

OCTINOXATE

7.5 g in 10 0 g

ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)

ZINC OXIDE

7.8 4 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

ISO METHYL-.ALPHA.-IO NO NE (UNII: 9 XP4LC555B)

HIGH DENSITY PO LYETHYLENE (UNII: UG0 0 KM4WR7)

PO LYGLYCERYL-4 ISO STEARATE (UNII: 8 20 DPX33S7)

TRIETHO XYCAPRYLYLSILANE (UNII: LDC331P0 8 E)

DISTEARDIMO NIUM HECTO RITE (UNII: X6 8 7XDK0 9 L)

CHLO RPHENESIN (UNII: I6 70 DAL4SZ)

BUTYLPHENYL METHYLPRO PIO NAL (UNII: T7540 GJV6 9 )

HYDRO XYCITRO NELLAL (UNII: 8 SQ0 VA4YUR)

CETYL PEG/PPG-10 /1 DIMETHICO NE ( HLB 2 ) (UNII: V2W71V8 T0 X)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

.BETA.-CITRO NELLO L, ( R) - (UNII: P0 1OUT9 6 4K)

TRIMETHYLSILO XYSILICATE ( M/Q 0 .8 -1.0 ) (UNII: 25LXE46 4L2)

.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6 O37OK2I)

LIMO NENE, ( +/-) - (UNII: 9 MC3I34447)

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

MICA (UNII: V8 A1AW0 8 8 0 )

DICAPRYLYL CARBO NATE (UNII: 6 0 9 A3V1SUA)

STARCH, CO RN (UNII: O8 232NY3SJ)

CERESIN (UNII: Q1LS2UJO3A)

SILICA DIMETHYL SILYLATE (UNII: EU2PSP0 G0 W)

CARNAUBA WAX (UNII: R12CBM0 EIZ)

KO JIC DIPALMITATE (UNII: 13N249 RWTM)

HEXYL LAURATE (UNII: 4CG9 F9 W0 1Q)

CAPRYLYL GLYCO L (UNII: 0 0 YIU5438 U)

GLYCYRRHIZA GLABRA (UNII: 278 8 Z9 758 H)

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