FDA.reportPublic FDA data

CG Smoothers Tinted Moisturizer and Sunscreen SPF 21

Manufacturer
Coty US LLC
Effective date
2021-12-09
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 22:23:46

Label at a glance#

ProductCG Smoothers Tinted Moisturizer and Sunscreen SPF 21
Active ingredientZINC OXIDE, OCTINOXATE
Label structure13 sections

Indications and 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

Dosage and administration

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 fr...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 6%

Zinc Oxide 3%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

  • For external use only.

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

if rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical help or contact a Posion Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

SPL UNCLASSIFIED SECTION

  • protect this product from excessive heat and direct sun

Inactive Ingredients

INACTIVE INGREDIENT SECTION

ingredients.jpgingredients.jpg

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-426-8374

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COVERGIRL

CG SMOOTHERS

BB

CREAM

TINTED MOISTURIZER

+ SUNSCREEN

BROAD SPECTRUM SPF 21

6618416410.JPG6618416410.JPGBACK.JPGBACK.JPGmodelfront.jpgmodelfront.jpg6618416430.jpg6618416430.jpg

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66184-16466184-164-10, 66184-164-20, 66184-164-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OIACT
POLYACRYLAMIDE (10000 MW)E2KR9C9V2IIACT
DIMETHICONOL (100000 CST)OSA9UP217SIACT
OLETH-3 PHOSPHATE8Q0Z18J1VLIACT
METHICONE (20 CST)6777U11MKTIACT
PANTHENOLWV9CM0O67ZIACT
GLYCERINPDC6A3C0OXIACT
DMDM HYDANTOINBYR0546TOWIACT
STEARETH-2153J3F32P58IACT
LAURETH-7Z95S6G8201IACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
ISOHEXADECANE918X1OUF1EIACT
OCTINOXATE4Y5P7MUD51ACTIB
ISOPROPYL PALMITATE8CRQ2TH63MIACT
STEARYL ALCOHOL2KR89I4H1YIACT
CETYL ALCOHOL936JST6JCNIACT
TALC7SEV7J4R1UIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
STEARETH-2V56DFE46J5IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d2ba58ee-2d11-4b4d-e053-2995a90aaaf583d294cb-77ab-7e6a-e053-2991aa0a2a282021-12-09WarningsExact identifier
spl id: d2ba58ee-2d11-4b4d-e053-2995a90aaaf5
spl set id: 83d294cb-77ab-7e6a-e053-2991aa0a2a28

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.