FDA.reportPublic FDA data

BEAUTY PIE - TRACELESS MINERAL BROAD SPECTRUM SPF 30 SUNSCREEN + PRIMER

Manufacturer
PML NYC, LLC
Effective date
2026-04-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:54:47

Label at a glance#

ProductTRACELESS MINERAL BROAD SPECTRUM SPF SUNSCREEN AND PRIMER
Active ingredientZINC OXIDE
Label structure10 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. Use a water-resistant sunscreen if swimming or sweating. Reapply at least every 2 hours, Sun Protection Measures: Spending time in the sun increases risk of skin cancer and early 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:...

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 12.4%

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 doctor if rash occurs. When using, this product should be kept away from eye area. Rinse with water to remove.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure. Use a water-resistant sunscreen if swimming or sweating. Reapply at least every 2 hours, Sun Protection Measures: Spending time in the sun increases risk of skin cancer and early 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 10:00 a.m. - 2:00 p.m. Wear long sleeved shirts, pants, hats and sunglasses. Children under 6 months: ask a doctor.

OTHER INFORMATION

OTHER SAFETY INFORMATION

PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUN. MAY STAIN SOME FABRICS

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water,C12-15 Alkyl Benzoate,Dimethicone,Argania Spinosa Kernel Oil,Tocopheryl Acetate,Cetearyl Alcohol,Propanediol,
Niacinamide,Polyhydroxystearic acid,Coco-Glucoside,Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer ,Glyceryl Stearate ,PEG-100 Stearate ,Silica ,Isohexadecane ,Pongamia Pinnata Seed Extract ,Xanthan Gum ,Bisabolol ,Citric Acid ,Hydroxyacetophenone ,Triethoxycaprylylsilane,Polysorbate 80,Polysilicone-11 ,Ethylhexylglycerin ,Trisodium Ethylenediamine Disuccinate ,Sodium Hydroxide ,Phenoxyethanol ,Yellow 5,Red 40

RECENT MAJOR CHANGES SECTION

DOSAGE & ADMINISTRATION added

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CARTONCARTON

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeCode 128US VersionBeauty Pie Face Primer SPF 30 -US CARTON.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59735-990-022026-01-29C16284748780-149896155-aa65-586f-e063-e6dba90add90BEAUTY PIE - TRACELESS MINERAL BROAD SPECTRUM SPF 30 SUNSCREEN + PRIMER
59735-990-042026-01-29C16284748780-149896155-aa65-586f-e063-e6dba90add90BEAUTY PIE - TRACELESS MINERAL BROAD SPECTRUM SPF 30 SUNSCREEN + PRIMER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59735-990-01TRACELESS MINERAL BROAD SPECTRUM SPF SUNSCREEN AND PRIMER50 g in 1 TUBECREAM503
59735-990-02TRACELESS MINERAL BROAD SPECTRUM SPF SUNSCREEN AND PRIMER1 in 1 CARTONCREAM13
59735-990-03TRACELESS MINERAL BROAD SPECTRUM SPF SUNSCREEN AND PRIMER50 g in 1 TUBECREAM503
59735-990-04TRACELESS MINERAL BROAD SPECTRUM SPF SUNSCREEN AND PRIMER1 in 1 CARTONCREAM13

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59735-99059735-990-01, 59735-990-02, 59735-990-03, 59735-990-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
NIACINAMIDE25X51I8RD4IACT
.ALPHA.-BISABOLOL, (+)-105S6I733ZIACT
XANTHAN GUMTTV12P4NEEIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
TRISODIUM ETHYLENEDIAMINE DISUCCINATEYA22H34H9QIACT
SODIUM HYDROXIDE55X04QC32IIACT
FD&C RED NO. 40WZB9127XOAIACT
DIMETHICONE 200RGS4T2AS00IACT
PROPANEDIOL5965N8W85TIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
COCO GLUCOSIDEICS790225BIACT
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW)1DXE3F3OZXIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
PEG-100 STEARATEYD01N1999RIACT
ISOHEXADECANE918X1OUF1EIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
ARGAN OIL4V59G5UW9XIACT
POLYSORBATE 806OZP39ZG8HIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
PHENOXYETHANOLHIE492ZZ3TIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
PONGAMIA PINNATA SEEDC2BRV53B1VIACT
ZINC OXIDESOI2LOH54ZACTIB

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
TRACELESS MINERAL BROAD SPECTRUM SPF SUNSCREEN AND PRIMERTRACELESS MINERAL BROAD SPECTRUM SPF SUNSCREEN AND PRIMERPML NYC, LLC1c2e9b0d-ba0e-1767-e063-6394a90a756c2026-04-23WarningsExact identifier
ndc (package): 59735-990-02
ndc (package): 59735-990-01
ndc (package): 59735-990-04
ndc (package): 59735-990-03
ndc (product): 59735-990
ndc11 (package): 59735099004
ndc11 (package): 59735099003
ndc11 (package): 59735099001
ndc11 (package): 59735099002
spl id: 502dc28f-4de5-0d86-e063-6394a90a12f7
spl set id: 1c2e9b0d-ba0e-1767-e063-6394a90a756c

Reported adverse events (FAERS/openFDA)#

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