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.
Face and Body Mineral SPF Non-Tinted
- Manufacturer
- Flawless Skin Care, LLC (dba Abby Skin Clinic) | Custom Analytics LLC | Fragrance Manufacturing Inc. (FMI) | Keystone Industries
- Effective date
- 2021-03-23
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:39:12
Label at a glance#
ProductFace and Body Mineral SPF Non-Tinted
Active ingredientTitanium Dioxide, Zinc Oxide
Label structure8 sections
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:
Titanium Dioxide 3%
Zinc Oxide 10%
PURPOSE:
Sunscreen
Sunscreen
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:
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:
- 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:
Butyloctyl Salicylate, Cl2-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cellulose Gum, Ceteareth 20, Cetearyl Alcohol, Citric Acid, Disodium EDTA, Glycereth-26, Glycerin, Glyceryl Stearate, Methyl Methacrylate Crosspolymer, Microcrystalline Cellulose, Octyldodecyl Neopentanoate, Polymethyl Methacrylate, Polysorbate 80, Polyurethane-2, Trans-1,3,3,3-Tetrafluoropropene, Tricontanyl PVP, Triethoxycaprylylsilane, Trimethoxycaprylylsilane, Water
OTHER 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
ABBY SKIN CARE
ABBY ODIAMAR PACLIBAR
FACE & BODY
MINERAL SPF
NON-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
3.5 oz | 100 g
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 81535-211-01 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-6993-d83d-e063-dadaa90ab31f | DRUG FACTS |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 81535-211-01 | Face and Body Mineral SPF Non-Tinted | 100 g in 1 CAN | AEROSOL, FOAM | 100 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 81535-211 | FACE AND BODY MINERAL SPF NON-TINTED (TITANIUM DIOXIDE, ZINC OXIDE) AEROSOL, FOAM [FLAWLESS SKIN CARE, LLC (DBA ABBY SKIN CLINIC)] | 1 | Legacy NDC, 1 package rows | 20210326_f4a34add-2791-43a0-8bf9-e96b5c75f167.zip |
Products#
Every source-derived product name is available through these pages.
- Face and Body Mineral SPF Non-Tinted
- Titanium Dioxide, Zinc Oxide
- Titanium Dioxide
- Zinc Oxide
- BUTYLOCTYL SALICYLATE
- ALKYL (C12-15) BENZOATE
- CAPRYLHYDROXAMIC ACID
- CAPRYLYL GLYCOL
- CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
- POLYOXYL 20 CETOSTEARYL ETHER
- CETOSTEARYL ALCOHOL
- CITRIC ACID MONOHYDRATE
- EDETATE DISODIUM ANHYDROUS
- GLYCERETH-26
- GLYCERIN
- GLYCERYL MONOSTEARATE
- METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER
- MICROCRYSTALLINE CELLULOSE
- OCTYLDODECYL NEOPENTANOATE
- POLYHYDROXYSTEARIC ACID (2300 MW)
- POLY(METHYL METHACRYLATE; 450000 MW)
- POLYSORBATE 80
- 1,3,3,3-TETRAFLUOROPROPENE, (1E)-
- TRICONTANYL POVIDONE
- TRIETHOXYCAPRYLYLSILANE
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 81535-211 | 81535-211-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| be28ca4c-97a8-4e3d-9c94-e2199ec95db4 | f4a34add-2791-43a0-8bf9-e96b5c75f167 | 2021-03-23 | Warnings | be28ca4c-97a8-4e3d-9c94-e2199ec95db4 f4a34add-2791-43a0-8bf9-e96b5c75f167 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.