CD DIORSKIN NUDE SKIN-GLOWING MAKEUP SUNSCREEN BROAD SPECTRUM SPF 15 041 OCHRE- octinoxate, titanium dioxide cream

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

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Active ingredient:
Octinoxate 3.00% Titanium Dioxide 4.35%
Available from:
Parfums Christian Dior
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Sunscreen. - helps prevent sunburn. - if used as directed with other sun protection measure (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.
Authorization status:
OTC monograph final
Authorization number:
61957-0120-1

CD DIORSKIN NUDE SKIN-GLOWING MAKEUP SUNSCREEN BROAD SPECTRUM SPF 15

041 OCHRE- octinoxate, titanium dioxide cream

Parfums Christian Dior

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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CD DIORSKIN NUDE SKIN-GLOWING MAKEUP SUNSCREEN BROAD SPECTRUM SPF 15

041 Ochre

Drug Facts

Active Ingredients

Octinoxate 3.00%

Titanium Dioxide 4.35%

Purpos e

Sunscreen.

Us es

helps prevent sunburn.

if used as directed with other sun protection measure (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.

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

rash occurs.

Keep out of reach of children

If swallowed, get medical help or contact 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.

Sun Protection Measures. Spending time in the sun increase your risk of skin cancer and early skin

aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher

and other sun protection measures including:

- limit the time in the sun, especially form 10 a.m. - 2 p.m.

- wear long-sleeve shirts, pants, hats and sunglasses.

Children under 6 months of age: ask a doctor.

Other Information

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

Inactive ingredients

AQUA (WATER), METHYL TRIMETHICONE, ALCOHOL, PHENYL TRIMETHICONE, PEG-9

POLYDIMETHYLSILOXYETHYL DIMETHICONE, ISODODECANE,

ACRYLATES/DIMETHICONE COPOLYMER, DIPHENYL DIMETHICONE/VINYL DIPHENYL

DIMETHICONE/SILSESQUIOXANE CROSS POLYLMER, ISODODECANE,

DIMETHICONOL/METHYLSILANOL/SILICATE CROSS POLYMER, STEARIC ACID, MICA,

PHENOXYETHANOL, SYNTHETIC FLUORPHLOGOPITE, ALUMINA, ALUMINUM

HYDROXIDE, SODIUM MYRISTOYL GLUTAMATE, GLYCERYL UNDECYL DIMETHICONE,

DISTEARDIMONIUM HETCTORITE, VP/VA COPOLYMER, SILICA SILYLATE, SILICA,

PROPYLENE CARBONATE, PARFUM (FRAGRANCE), DIMETHICONE, BHT,

DIMETHICONE/METHICONE COPOLYMER, SERICIN, LINALOOL, LIMONENE,

BUTYLPHENYL METHYL PROPIONAL, GLYCERIN, HIBISCUS SABDARIFFA FLOWER

EXTRACT, RHODOCHROSITE EXTRACT, MALVA SYLVESTRIS (MALLOW) EXTRACT,

HYDROLYZED LINSEED EXTRACT, CITRONELLOL BALANITES, ROXBURGHI SEED OIL,

CITRIC ACID, POTASSIUM SORBATE, SORBIC ACID, AJUGA TURKESTANICA EXTRACT.

[MAY CONTAIN: CI 77163 (BISMUTH OXYCHLORIDE), CI 77491, CI 77492, CI 77499 (IRON

OXIDES), CI 77891 (TITANIUM DIOXIDE).

Des cription

DIORSKIN NUDE, the 1st Dior foundation specially enriched with naturally derived skincare

ingredients for a complexion that is even more "nude" and sublime in all types of lighting. Skin

becomes more beautiful and radiant day after day. With the product line's iconic Diorskin Nude Fluid

foundation, your complexion instantly becomes even, fresh and radiant. Our ultimate Nude makeup is

unique and natural - simply sublime!

041 DIORSKIN NUDE NUDE SKIN-GLOWING MAKEUP SUNSCREEN BROAD SPECTRUM

SPF 15 Dior 30 ml 1 FL. OZ MADE IN FRANCE Parfums Christian Dior 33, avenue Hocha,

75008 Paris - France In USA 19E57 NY. NY 10022 www.dior.com

Product Labels

CD DIORSKIN NUDE SKIN-GLOWING MAKEUP SUNSCREEN BROAD

SPECTRUM SPF 15 041 OCHRE

octinoxate, titanium dioxide cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 19 57-0 120

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

30 mg in 1 mL

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP) (TITANIUM DIOXIDE - UNII:15FIX9 V2JP)

TITANIUM DIOXIDE

43.5 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

METHYL TRIMETHICO NE (UNII: S73ZQI0 GXM)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

PHENYL TRIMETHICO NE (UNII: DR0 K5NOJ4R)

ISO DO DECANE (UNII: A8 28 9 P6 8 Y2)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

MICA (UNII: V8 A1AW0 8 8 0 )

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

ALUMINUM O XIDE (UNII: LMI26 O6 9 33)

ALUMINUM HYDRO XIDE (UNII: 5QB0 T2IUN0 )

DISO DIUM MYRISTO YL GLUTAMATE (UNII: 3LVY10 0 1N6 )

CO PO VIDO NE K2 5-3 1 (UNII: D9 C330 MD8 B)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

PRO PYLENE CARBO NATE (UNII: 8 D0 8 K3S51E)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

BUTYLATED HYDRO XYTO LUENE (UNII: 1P9 D0 Z171K)

LINALO O L, ( +/-) - (UNII: D8 1QY6 I8 8 E)

GLYCERIN (UNII: PDC6 A3C0 OX)

HIBISCUS SABDARIFFA FLO WER (UNII: 45TGG6 IU6 M)

MANGANESE CARBO NATE (UNII: 9 ZV57512ZM)

MALVA SYLVESTRIS FLO WERING TO P (UNII: X1U1U0 N9 0 J)

BALANITES RO XBURGHII SEED O IL (UNII: CZ6 7V4ZW0 I)

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

PO TASSIUM SO RBATE (UNII: 1VPU26 JZZ4)

SO RBIC ACID (UNII: X0 45WJ9 8 9 B)

AJUGA TURKESTANICA TO P (UNII: 8 X9 0 478 S3S)

BISMUTH O XYCHLO RIDE (UNII: 4ZR79 2I58 7)

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

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

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

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 19 57-0 120 -1

1 in 1 CARTON

0 8 /27/20 12

1

30 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

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

0 8 /27/20 12

Labeler -

Parfums Christian Dior (275252245)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Parfums Christian Dior

Parfums Christian Dio r

39 6 39 3746

ma nufa c ture (6 19 57-0 120 )

Revised: 12/2018

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