Search by Drug Name or NDC
NDC 81535-0210-01 Face and Body Mineral SPF - Tinted 30; 100 mg/g; mg/g Details
Face and Body Mineral SPF - Tinted 30; 100 mg/g; mg/g
Face and Body Mineral SPF - Tinted is a TOPICAL AEROSOL, FOAM in the HUMAN OTC DRUG category. It is labeled and distributed by Flawless Skin Care, LLC (dba Abby Skin Clinic). The primary component is TITANIUM DIOXIDE; ZINC OXIDE.
Product Information
NDC | 81535-0210 |
---|---|
Product ID | 81535-210_80cd6814-9d07-4b69-908e-bbcf5ccacf8a |
Associated GPIs | |
GCN Sequence Number | n/a |
GCN Sequence Number Description | n/a |
HIC3 | n/a |
HIC3 Description | n/a |
GCN | n/a |
HICL Sequence Number | n/a |
HICL Sequence Number Description | n/a |
Brand/Generic | n/a |
Proprietary Name | Face and Body Mineral SPF - Tinted |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Titanium Dioxide, Zinc Oxide |
Product Type | HUMAN OTC DRUG |
Dosage Form | AEROSOL, FOAM |
Route | TOPICAL |
Active Ingredient Strength | 30; 100 |
Active Ingredient Units | mg/g; mg/g |
Substance Name | TITANIUM DIOXIDE; ZINC OXIDE |
Labeler Name | Flawless Skin Care, LLC (dba Abby Skin Clinic) |
Pharmaceutical Class | n/a |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH NOT FINAL |
Application Number | part352 |
Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 81535-0210-01 (81535021001)
NDC Package Code | 81535-210-01 |
---|---|
Billing NDC | 81535021001 |
Package | 100 g in 1 CAN (81535-210-01) |
Marketing Start Date | 2020-03-01 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 24ab1e92-fe1a-4022-bc4e-80806ebc5a59 Details
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:
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:
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:
Principal Display Panel - 100 g Can Label
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
INGREDIENTS AND APPEARANCE
FACE AND BODY MINERAL SPF - TINTED
titanium dioxide, zinc oxide aerosol, foam |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Labeler - Flawless Skin Care, LLC (dba Abby Skin Clinic) (031934930) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Custom Analytics LLC | 144949372 | ANALYSIS(81535-210) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Fragrance Manufacturing Inc. (FMI) | 793406000 | MANUFACTURE(81535-210) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Keystone Industries | 014769301 | PACK(81535-210) |