FDA.reportPublic FDA data

Premier Tinted Mineral Sunscreen

Manufacturer
Premier Plastic Surgery
Effective date
2026-03-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:50:45

Label at a glance#

ProductPremier Tinted Mineral Sunscreen
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure9 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 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 15 or higher and other sun protection measures including: limit time in the sun, esp...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 7.5%

Titanium Dioxide 3.2%

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

OTC - DO NOT USE SECTION

Do not useon damaged or broken skin

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctorif rash occurs

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
  • 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 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m. - 2 p.m.
    • wear long-sleeve shirts, pants, hats and sunglasses
  • children under 6 months: Ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Caprylic Capric Triglyceride, Cyclopentasiloxane, C30-45 Alkylcetearyl, Dimethicone Crosspolymer, C13-15 Alkane, Stearic Acid, Aluminum Hydroxide, Polyhydroxystearic Acid, Octyldodecyl Neopentanoate, Glycerin, Buddleja Davidii (Summer Lilac) Extract, Thymus Vulgaris (Thyme) Extract, Sodium Chloride, Sorbitan Oleate,Tetrasodium Edta, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Perflourodecalin, Mica, Titanium Dioxide (CI77891), Iron Oxides (CI77491).

Other Information

SPL UNCLASSIFIED SECTION

  • protect this product from excessive heat and direct sun

Principal Display Panel -

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Stay Ageless Tinted Mineral SunscreenStay Ageless Tinted Mineral Sunscreen

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81341-0652-6Premier Tinted Mineral Sunscreen47 g in 1 BOTTLE, PUMPCREAM472

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
81341-065281341-0652-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
MICAV8A1AW0880IACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
WATER059QF0KO0RIACT
BUDDLEJA DAVIDII LEAFX380815D32IACT
THYMUS VULGARIS LEAFGRX3499643IACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)UF7620L1W6IACT
C13-15 ALKANE114P5I43UJIACT
GLYCERINPDC6A3C0OXIACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
PERFLUOROMETHYLDECALINVWJ68OB6TMIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
SORBIC ACIDX045WJ989BIACT
SODIUM CHLORIDE451W47IQ8XIACT
SORBITAN MONOOLEATE06XEA2VD56IACT
TETRASODIUM EDTAMP1J8420LUIACT
ZINC OXIDESOI2LOH54ZACTIM
TITANIUM DIOXIDE15FIX9V2JPACTIB
CYCLOPENTASILOXANE0THT5PCI0RIACT
C30-45 ALKYL CETEARYL DIMETHICONE CROSSPOLYMER4ZK9VP326RIACT
STEARIC ACID4ELV7Z65APIACT

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
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Premier Plastic Surgery4d3a36b9-7d60-01ac-e063-6294a90af4fb2026-03-18WarningsExact identifier
ndc (package): 81341-0652-6
ndc (product): 81341-0652
ndc11 (package): 81341065206
spl id: 4d4f9e0c-60f9-ac5f-e063-6394a90add62
spl set id: 4d3a36b9-7d60-01ac-e063-6294a90af4fb

Reported adverse events (FAERS/openFDA)#

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