FDA.reportPublic FDA data

PCA Skincare Sheer Tint Body SPF 30 Spray

Manufacturer
physicians Care Alliance, LLC (d/b/a PCA Skin)
Effective date
2020-12-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:58:18

Label at a glance#

ProductSheer Tint SPF 30
Active ingredientZINC OXIDE
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 canccer and early skin aging caused by the sun

Dosage and administration

Hold container 4 to 6 inches from the skin to apply Spray liberally and spread evenly by hand 15 minutes before sun exposure Do not spray directly into face. Spray on hands then apply to face. Do not apply in windy conditions Use in well-ventilated area Reapply -after 80 minutes of swimming or sweating -immediately after towel drying -at least every 2 hours Children under 6 months: ask a doctor Sun Protection Meas...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide (15%)

Prupose

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 canccer 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 rahs occurs

When using this product keep out of eyes. If the product is accidentally sprayed into eyes rinse with water to remove

Contents under pressure

Do not puncture or incinerate

Do not expose to heat or store at temperatures above 120 F

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

Hold container 4 to 6 inches from the skin to apply

Spray liberally and spread evenly by hand 15 minutes before sun exposure

Do not spray directly into face. Spray on hands then apply to face.

Do not apply in windy conditions

Use in well-ventilated area

Reapply

-after 80 minutes of swimming or sweating

-immediately after towel drying

-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, regularly use a sunscreen with a borad 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 prodct from excessive heat and direct sun

Questions or Comments?

OTC - QUESTIONS SECTION

877-722-7546

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Bentonite

Bisabolol

Butyloctyl Salicylate

Caprylhydroxamic Acid

Caprylic/Capric Triglyceride

Capryloyl Glycerin/Sebacic Acid Copolymer

Caprylyl Glycol

Cellulose Gum

Cetearyl Alcohol

Coco-Glucoside

Ethyl Macadamiate

Glycerin

Iron Oxides

Jojoba Esters

Methyl Dihydroabietate

Microcrystalline Cellulose

Octyldodecyl Oleate

Propanediol

Shea Butter Ethyl Esters

Tocopherol

Water

label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ArtworkArtwork

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68726-26768726-267-13

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
BENTONITEA3N5ZCN45CIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
CAPRYLYL GLYCOL00YIU5438UIACT
TOCOPHEROLR0ZB2556P8IACT
ETHYL MACADAMIATEANA2NCS6V1IACT
LEVOMENOL24WE03BX2TIACT
FERRIC OXIDE RED1K09F3G675IACT
METHYL DIHYDROABIETATE7666FJ0J9FIACT
OCTYLDODECYL OLEATEMCA43PK7MHIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S)N7YC58165TIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
JOJOBA OIL724GKU717MIACT
WATER059QF0KO0RIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
PROPANEDIOL5965N8W85TIACT
GLYCERINPDC6A3C0OXIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
SHEA BUTTER ETHYL ESTERSV2CI786FPGIACT
COCO GLUCOSIDEICS790225BIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT

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
e298a2e7-8508-5e98-e053-2a95a90a178db7c683ea-bfe6-87cb-e053-2995a90aaf722022-06-29WarningsExact identifier
spl set id: b7c683ea-bfe6-87cb-e053-2995a90aaf72

Reported adverse events (FAERS/openFDA)#

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