CC CREME 02 SOIN PERFECTEUR DE PEAU SKIN PERFECTING- octinoxate, octisalate, titanium dioxide cream

CC CREME 02 Soin Perfecteur de peau Skin Perfecting by

Drug Labeling and Warnings

CC CREME 02 Soin Perfecteur de peau Skin Perfecting by is a Otc medication manufactured, distributed, or labeled by Codif International. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug facts

Active Ingredients

Octinoxate 5,99%
Octisalate 2%
Titanium Dioxide 5,34%

Purpose

Sunscreen

Uses

• helps prevent sunburn.
• if used as directed with other sun protection measures (see Directions), decreases the risk of sun cancer and early skin aging caused by the sun.

Warnings

For external use only

Do not use

on damaged skin 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 product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:

• apply liberally 15 minutes before sun exposure
• reapply at least every two hours
• use a water resistant sunscreen if swimming or sweating
  Sun protections measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regurlarly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
• limit time in the sun, especially from 10 a.m. - 2 p.m.
  wear long-sleeve shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor

Other information

Protect this product from excessive heat and direct sun

Inactive Ingredients

aqua (water) / eau, glycerin, propylheptyl caprylate, dimethicone, dipropylene glycol, glyceryl stearate, peg-100 stearate, dicaprylyl carbonate, pentaerythrityl distearate, caprylic/capric triglyceride, isostearyl isostearate, cetearyl alcohol, magnesium aluminum silicate, glycol palmitate, phenoxyethanol, methyl methacrylate crosspolymer, peg-10 dimethicone, polyglyceryl- 3 diisostearate, ppg-5-ceteth-20, polymethyl methacrylate, alumina, xanthan gum, dimethiconol, parfum (fragrance), chlorphenesin, ceteareth-20, hydroxyethyl acrylate /
sodium acryloyldimethyltaurate copolymer, sodium citrate, caprylyl glycol, squalane, citric acid, silica, dictyopteris polypodioides extract, polysorbate 60, plankton extract, bht, jania rubens extract, tocopherol, silene uniflora extract, titanium dioxide, iron oxides

Package Labeling:

INGREDIENTS AND APPEARANCE

CC CREME 02 SOIN PERFECTEUR DE PEAU SKIN PERFECTING 
octinoxate, octisalate, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66846-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	59.9 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	20 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	53.4 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD)
DIMETHICONE (UNII: 92RU3N3Y1O)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
PENTAERYTHRITYL DISTEARATE (UNII: 697WOT8HNB)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCOL PALMITATE (UNII: T80A3T38WE)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
PPG-5-CETETH-20 (UNII: 4AAN25P8P4)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
ALUMINUM OXIDE (UNII: LMI26O6933)
XANTHAN GUM (UNII: TTV12P4NEE)
CHLORPHENESIN (UNII: I670DAL4SZ)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SQUALANE (UNII: GW89575KF9)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DICTYOPTERIS POLYPODIOIDES (UNII: 83H6O5GR42)
POLYSORBATE 60 (UNII: CAL22UVI4M)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66846-011-50	1 in 1 CARTON	05/13/2017
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 not final	part352	05/13/2017

Labeler - Codif International (396156010)