COVERGIRL CGSMOOTHERS BB TINTED MOISTURIZER BROAD SPECTRUM SPF 21 (ALL SHADES)- octinoxate and zinc oxide cream

Covergirl cgsmoothers BB Tinted Moisturizer by

Drug Labeling and Warnings

Covergirl cgsmoothers BB Tinted Moisturizer by is a Otc medication manufactured, distributed, or labeled by Noxell Corporation, COTY US LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Octinoxate 6%
Zinc Oxide 3%

Purpose

Sunscreen

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

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 product is 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 water resistant sunscreen if swimming or sweating
• Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • limit time in sun, especially from 10 a.m. – 2 p.m.
  • wear long-sleeved 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

water, glycerin, isohexadecane, isopropyl palmitate, oleth-3 phosphate, sucrose polycottonseedate, tocopheryl acetate, iodopropynyl butylcarbamate, dmdm hydantoin, steareth-21, steareth-2, stearyl alcohol, behenyl alcohol, talc, polyacrylamide, dimethicone, dimethiconol, panthenol, c13-14 isoparaffin, disodium edta, bht, beta-carotene, methicone, cetyl alcohol, laureth-7, titanium dioxide, iron oxides.

Questions or comments?

Call 1-800-426-8374

PRINCIPAL DISPLAY PANEL - 40 ml Tube Blister Pack Label

cg smoothers ®
BB cream

805
fair to light

COVERGIRL

10in1

instant
skin
enhancer

40 ml (1.35 fl oz)

INGREDIENTS AND APPEARANCE

COVERGIRL CGSMOOTHERS BB TINTED MOISTURIZER   BROAD SPECTRUM SPF 21 (ALL SHADES)
octinoxate and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 22700-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ISOHEXADECANE (UNII: 918X1OUF1E)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
DMDM HYDANTOIN (UNII: BYR0546TOW)
STEARETH-21 (UNII: 53J3F32P58)
STEARETH-2 (UNII: V56DFE46J5)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
DOCOSANOL (UNII: 9G1OE216XY)
TALC (UNII: 7SEV7J4R1U)
DIMETHICONE (UNII: 92RU3N3Y1O)
PANTHENOL (UNII: WV9CM0O67Z)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.BETA.-CAROTENE (UNII: 01YAE03M7J)
METHICONE (20 CST) (UNII: 6777U11MKT)
CETYL ALCOHOL (UNII: 936JST6JCN)
LAURETH-7 (UNII: Z95S6G8201)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 22700-001-40	1 in 1 BLISTER PACK	06/01/2016
1		40 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	06/01/2016

Labeler - Noxell Corporation (003082997)

Registrant - COTY US LLC (039056361)

Establishment
Name	Address	ID/FEI	Business Operations
Noxell Corporation		003082997	relabel(22700-001)