Face and Body Mineral SPF - Tinted

Manufacturer
Flawless Skin Care, LLC (dba Abby Skin Clinic) | Custom Analytics LLC | Fragrance Manufacturing Inc. (FMI) | Keystone Industries
Effective date
2020-03-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:39:04

Label at a glance#

ProductFace and Body Mineral SPF - Tinted
Active ingredientTitanium Dioxide, Zinc 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 cancer and early skin aging caused by the sun.

Dosage and administration

Shake well before using. Push nozzle up to release safety tab. Apply liberally 15 minutes before sun exposure. Reapply: After 40 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 B...

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 3%

Zinc Oxide 10%

PURPOSE:

OTC - PURPOSE SECTION

Sunscreen

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 rash occurs. When using this product, keep out of eyes. Rinse with water to remove. Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

  • Shake well before using.
  • Push nozzle up to release safety tab.
  • Apply liberally 15 minutes before sun exposure.
  • Reapply:
    • After 40 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 Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
    • Limit time in the sun, especially from 10 am-2 pm
    • Wear long-sleeved shirts, pants, hats, and sunglasses

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Bismuth Oxychloride, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cellulose Gum, Ceteareth-20, Cetearyl Alcohol, Citric Acid, Disodium EDTA, Glycereth-26, Glycerin, Glyceryl Stearate, Iron Oxides, Methyl Methacrylate Crosspolymer, Mica, Microcrystalline Cellulose, Octyldodecyl Neopentanoate, Polymethyl Methacrylate, Polysorbate 80, Polyurethane-2, Trans-1,3,3,3-TetrafIuoropropene, Triacontanyl PVP, Triethoxycaprylylsilane,Trimethoxycaprylylsilane, Water

OTHER INFORMATION:

OTHER SAFETY INFORMATION

  • Protect this product from excessive heat and direct sun
  • May stain some fabrics
  • Store between 68° to 104° F (20° to 40° C).
  • Do not store at temperatures above 120° F.

Principal Display Panel - 100 g Can Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ABBY SKIN CARE

ABBY ODIAMAR PACLIBAR

FACE & BODY
MINERAL SPF
TINTED

Oil Free Mousse Sunscreen

broad spectrum SPF 30

water resistant (40 mins)

  • Great for all skin types
  • Photo-stable will not degrade in sunlight
  • FREE of chemical sunscreen filters, dyes,
    fragrances, oils and preservatives
  • Reef friendly
  • non-comedogenic

Net Wt. 3.5 oz | 100 g

Principal Display Panel - 100 g Can Label
Principal Display Panel - 100 g Can Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81535-210-012025-01-30C16284748780-12cef2736-7964-d83d-e063-dadaa90ab31fDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81535-210-01Face and Body Mineral SPF - Tinted100 g in 1 CANAEROSOL, FOAM1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81535-210FACE AND BODY MINERAL SPF - TINTED (TITANIUM DIOXIDE, ZINC OXIDE) AEROSOL, FOAM [FLAWLESS SKIN CARE, LLC (DBA ABBY SKIN CLINIC)]1Legacy NDC, 1 package rows20210320_24ab1e92-fe1a-4022-bc4e-80806ebc5a59.zip

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
81535-21081535-210-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

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
80cd6814-9d07-4b69-908e-bbcf5ccacf8a24ab1e92-fe1a-4022-bc4e-80806ebc5a592020-03-17WarningsExact identifier
spl id: 80cd6814-9d07-4b69-908e-bbcf5ccacf8a
spl set id: 24ab1e92-fe1a-4022-bc4e-80806ebc5a59

Reported adverse events (FAERS/openFDA)#

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