FDA.reportPublic FDA data

sheer tint

Manufacturer
CP Skin Health Group, Inc.
Effective date
2024-02-14
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:08:39

Label at a glance#

Productsheer tint SPF 45
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure8 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: -after 80 minutes of swimming or sweating -immediately after towel drying -at least every 2 hours Children under 6 montha: 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, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other skin protec...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide (7.6%)

Zinc Oxide (8.0%)

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 on damaged or broken skin

Stop use and ask a doctor if skin rash occurs.

When using this product keep out of eyes. Rinse with water to remove

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure

Reapply:

-after 80 minutes of swimming or sweating

-immediately after towel drying

-at least every 2 hours

Children under 6 montha: 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, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other skin protecting measures including:

-limit time in the sun, especially from 10 a.m. - 2 p.m.

-wear long-sleeved shirts, pants, hats, and sunglasses.

Other Information

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

Questions?

OTC - QUESTIONS SECTION

Please call 877-722-7546

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Alumina

Butyloctyl Salicylate

C12-15 Alkyl Benzoate

Caprylyl Glycol

Dimethicone

Dimethicone/PEG-10/15 Crosspolymer

Dimethicone/Vinyl Dimethicone Crosspolymer

Ethylhexylglycerin

Hexylene Glycol

Hydrogen Dimethicone

Iron Oxides

Isododecane

Jojoba Esters

Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer

Octyldodecanol

PEG-9 Polydimethylsiloxyethyl Dimethicone

Phenoxyethanol

Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone

Polymethylsilsesquioxane

Sodium Chloride

Triethoxycaprylylsilane

Trihydroxystearin

Water

Sheet Tint

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sheet TintSheet Tint

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68726-269-11sheer tintSPF 45177 mL in 1 CANLOTION1777
68726-269-53sheer tintSPF 45192 mL in 1 BOTTLELOTION1927

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68726-269SHEER TINT SPF 45 (BROAD SPECTRUM) LOTION [CP SKIN HEALTH GROUP, INC.]7Current NDC, Legacy NDC, 2 package rows20240215_b7c5cedd-ff68-74de-e053-2a95a90a3796.zip

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68726-26968726-269-11, 68726-269-53

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
WATER059QF0KO0RIACT
DIMETHICONE92RU3N3Y1OIACT
DIMETHICONE/PEG-10/15 CROSSPOLYMER21AS8B1BSSIACT
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMEREG97988M5QIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
SODIUM CHLORIDE451W47IQ8XIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
PHENOXYETHANOLHIE492ZZ3TIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
CAPRYLYL GLYCOL00YIU5438UIACT
HYDROGEN DIMETHICONE (13 CST)4QGR4P2YOIIACT
JOJOBA OIL, RANDOMIZED7F0EV20QYLIACT
TRIHYDROXYSTEARIN06YD7896S3IACT
ALUMINUM OXIDELMI26O6933IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S)RLA2U05Z4QIACT
OCTYLDODECANOL461N1O614YIACT
ZINC OXIDESOI2LOH54ZACTIB
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)H895X08VNQIACT
ISODODECANEA8289P68Y2IACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONETYP81E471FIACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT
FERROSOFERRIC OXIDEXM0M87F357IACT
FERRIC OXIDE RED1K09F3G675IACT

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
sheer tint SPF 45BROAD SPECTRUMCP Skin Health Group, Inc.b7c5cedd-ff68-74de-e053-2a95a90a37962024-02-14WarningsExact identifier
ndc (package): 68726-269-53
ndc (package): 68726-269-11
ndc (product): 68726-269
ndc11 (package): 68726026911
ndc11 (package): 68726026953
spl id: 1159ecc2-1e51-5244-e063-6394a90a3c5d
spl set id: b7c5cedd-ff68-74de-e053-2a95a90a3796

Reported adverse events (FAERS/openFDA)#

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