FACE AND BODY MINERAL SPF - TINTED- titanium dioxide, zinc oxide aerosol, foam

Face and Body Mineral SPF - Tinted by

Drug Labeling and Warnings

Face and Body Mineral SPF - Tinted by is a Otc medication manufactured, distributed, or labeled by Flawless Skin Care, LLC (dba Abby Skin Clinic), Custom Analytics LLC, Fragrance Manufacturing Inc. (FMI), Keystone Industries. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

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:

• 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
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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81535-210
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	30 mg  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
GLYCERETH-26 (UNII: NNE56F2N14)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
MICA (UNII: V8A1AW0880)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
1,3,3,3-TETRAFLUOROPROPENE, (1E)- (UNII: 5I2481UOO8)
TRICONTANYL POVIDONE (UNII: N0SS3Q238D)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81535-210-01	100 g in 1 CAN; Type 0: Not a Combination Product	03/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/24/2018

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)