FACE REALITY MINERAL MATTE SPF 28 SUNSCREEN SPF 28- zinc oxide, titanium dioxide cream

Face Reality mineral matte spf 28 Sunscreen SPF 28 by

Drug Labeling and Warnings

Face Reality mineral matte spf 28 Sunscreen SPF 28 by is a Otc medication manufactured, distributed, or labeled by Face Reality, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Zinc Oxide 11.6%, Titanium Dioxide 0.67%

Purpose

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.

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

• if rash occurs.

Keep out of reach of children.

• If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally 15 minutes before sun exposure
• reapply at least every 2 hours
• use a water-resistant sunscreen if swimming or sweating
• 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 of 15 or higher and other sun protection measures including:
• limit time in the sun, especially from 10 a.m.-2 p.m.
• wear long-sleeved shirts, pants, hats, and sunglasses
• Children under 6 months: Ask a doctor

Other information

• Store at room temperature of 68-77 F (22-25 C).

Inactive ingredients:

Aqua (Water), Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cetearyl Glucoside, Coco-Caprylate/Caprate, Polysorbate 60, Glycerin, Squalane, Glyceryl Isostearate, Dicaprylyl Ether, Isononyl Isononanoate, Magnesium Aluminum Silicate, 1,2-Hexanediol, Citric Acid, Caprylyl Glycol, Polyglyceryl-6 Polyricinoleate, Xanthan Gum, Polyhydroxystearic Acid, Leuconostoc/Radish Root Ferment Filtrate, Populus Tremuloides Bark Extract, Alumina, Gluconolactone, Potassium Sorbate, Aloe Barbadensis Leaf Juice Powder, Helianthus Annuus (Sunflower) Seed Oil, Trisodium Ethylenediamine Disuccinate, Lonicera Caprifolium (Honeysuckle) Flower Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Fructooligosaccharides (D-beta), Allantoin, Simethicone, Tocopherol (D-alpha), Tropolone.

Questions or comments?

1-866-477-3077

Package Labeling:

INGREDIENTS AND APPEARANCE

FACE REALITY MINERAL MATTE SPF 28 SUNSCREEN SPF 28 
zinc oxide, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70707-454
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	116 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (CI 77891 - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	6.7 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)
POLYSORBATE 60 (UNII: CAL22UVI4M)
GLYCERIN (UNII: PDC6A3C0OX)
SQUALANE (UNII: GW89575KF9)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
DICAPRYLYL ETHER (UNII: 77JZM5516Z)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)
XANTHAN GUM (UNII: TTV12P4NEE)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
POPULUS TREMULOIDES BARK (UNII: 5543O0CEID)
ALUMINA (UNII: LMI26O6933)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
ALOE BARBADENSIS LEAF JUICE POWDER (UNII: ZY81Z83H0X)
SUNFLOWER OIL (UNII: 3W1JG795YI)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)
ALLANTOIN (UNII: 344S277G0Z)
TOCOPHEROL (UNII: R0ZB2556P8)
TROPOLONE (UNII: 7L6DL16P1T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70707-454-01	1 in 1 CARTON	10/01/2024
1		60 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/01/2024

Labeler - Face Reality, LLC (602958071)