DARK CC CREME BROAD SPECTRUM SPF 15 JAFRA- zinc oxide cream

Dark CC creme Broad Spectrum SPF 15 by

Drug Labeling and Warnings

Dark CC creme Broad Spectrum SPF 15 by is a Otc medication manufactured, distributed, or labeled by Jafra Cosmetics International, Jafra Manufacturing, S.A. de C.V. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active

ingredients                   Purpose

Zinc Oxide 6.8% ......... Sunscreen

PURPOSE

Uses

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

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs

WARNINGS

• For external use only
• Do not use on damaged or broken skin
• When using this productkeep out of eyes. Rinse with water to remove.
  

DOSAGE & ADMINISTRATION

Directions

• apply liberally 15 minutes before sun exposure
• use a water resistant sunscreen if swimming of sweating
• reapply at least every 2 hours
• children under 6 months: Ask a doctor
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularyl 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
  

INACTIVE INGREDIENT

Water/Aqua, Cyclopentasiloxane, PEG/PPG-18/18 Dimethicone, Cyclomethicone, Caprylic Capric Triglyceride, Polyhyroxystearic Acid, Propanediol, Titanium Dioxide/CI 77891, Triethoxycaprylysilane, Dimethicone, PEG-10 Dimethicone, Disteardimonium Hectorite, Boron Nitride, Iron Oxides/ CI 77491/CI 77492/CI 77499, Methicone, Glycerin, Sodium Chloride, Sodium Dehydroacetate, DMDM Hydantoin, Palmitic Acid, Disodium EDTA, Dextrin, Palmitate, PEG-4 Laurate, Iodopropynyl Butylcarbamate, Cucumis Sativus Extract, Glycrrhiza Glabra Extract, Tocopherol

PRINCIPAL DISPLAY PANEL

Dark

Jafra

CC Creme

Broad Spectrum SPF 15

30 ml / 1 FL OZ (US)

INGREDIENTS AND APPEARANCE

DARK CC CREME BROAD SPECTRUM SPF 15  JAFRA
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-237
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	6.8 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
CYCLOMETHICONE (UNII: NMQ347994Z)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
PROPANEDIOL (UNII: 5965N8W85T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BORON NITRIDE (UNII: 2U4T60A6YD)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
METHICONE (20 CST) (UNII: 6777U11MKT)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
DMDM HYDANTOIN (UNII: BYR0546TOW)
PALMITIC ACID (UNII: 2V16EO95H1)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PEG-4 LAURATE (UNII: AYF4VM3N1Z)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
CUCUMBER (UNII: YY7C30VXJT)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-237-02	1 in 1 BOX	07/13/2015
1	NDC: 68828-237-01	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 final	part352	07/13/2015

Labeler - Jafra Cosmetics International (041676479)

Registrant - Jafra Cosmetics International (041676479)

Establishment
Name	Address	ID/FEI	Business Operations
Jafra Manufacturing, S.A. de C.V		814732061	manufacture(68828-237)