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

Key Label Information#

Active Ingredients And Purpose

Active Ingredients

Zinc Oxide 7.5% Titanium Dioxide 3.2%

Purpose

Sunscreen

Uses

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

Warnings

Warnings

For external use only

Directions And Dosage

Directions

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

Other Label Information

Inactive Ingredients

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).

Principal Display Panel -

Label Images#

Pura Vida SP06
Pura Vida SP06

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#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81341-065281341-0652-6

Ingredients#

Complete SPL Sections#

SPL UNCLASSIFIED SECTION

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

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

Source Document#

Source XML