CG SMOOTHERS TINTED MOISTURIZER AND SUNSCREEN SPF 21- octinoxate, zinc oxide liquid

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

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Active ingredient:
Octinoxate 6%, Zinc Oxide 3%
Available from:
Coty US LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Sunscreen - 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 on damaged or broken skin. if rash occurs.
Authorization status:
OTC monograph not final
Authorization number:
66184-164-10, 66184-164-20, 66184-164-30

CG SMOOTHERS TINTED MOISTURIZER AND SUNSCREEN SPF 21- octinoxate, zinc

oxide liquid

Coty US LLC

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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CG Smoothers Tinted Moisturizer and Sunscreen SPF 21

Active Ingredients

Octinoxate 6%

Zinc Oxide 3%

Purpos e

Sunscreen

Us es

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 Posion 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 the 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

Questions or comments?

Call 1-800-426-8374

COVERGIRL

CG SMOOTHERS

CREAM

TINTED MOISTURIZER

+ SUNSCREEN

BROAD SPECTRUM SPF 21

CG SMOOTHERS TINTED MOISTURIZER AND SUNSCREEN SPF 21

octinoxate, zinc oxide liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 6 18 4-16 4

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

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

ZINC OXIDE

3 g in 10 0 mL

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

OCTINOXATE

6 g in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

PO LYACRYLAMIDE ( 10 0 0 0 MW) (UNII: E2KR9 C9 V2I)

DIMETHICO NO L ( 10 0 0 0 0 CST) (UNII: OSA9 UP217S)

O LETH-3 PHO SPHATE (UNII: 8 Q0 Z18 J1VL)

METHICO NE ( 2 0 CST) (UNII: 6 777U11MKT)

PANTHENO L (UNII: WV9 CM0 O6 7Z)

GLYCERIN (UNII: PDC6 A3C0 OX)

DMDM HYDANTO IN (UNII: BYR0 546 TOW)

STEARETH-2 1 (UNII: 53J3F32P58 )

LAURETH-7 (UNII: Z9 5S6 G8 20 1)

IO DO PRO PYNYL BUTYLCARBAMATE (UNII: 6 0 3P14DHEB)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

WATER (UNII: 0 59 QF0 KO0 R)

ISO HEXADECANE (UNII: 9 18 X1OUF1E)

ISO PRO PYL PALMITATE (UNII: 8 CRQ2TH6 3M)

STEARYL ALCO HO L (UNII: 2KR8 9 I4H1Y)

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

TALC (UNII: 7SEV7J4R1U)

C13 -14 ISO PARAFFIN (UNII: E4F12ROE70 )

STEARETH-2 (UNII: V56 DFE46 J5)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 6 18 4-16 4-10

40 mL in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

0 3/11/20 19

2

NDC:6 6 18 4-16 4-20

40 mL in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

0 3/11/20 19

3

NDC:6 6 18 4-16 4-30

40 mL in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

0 3/11/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 3/11/20 19

Coty US LLC

Labeler -

Coty US LLC (039056361)

Revised: 2/2020

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