MOISTURIZER SPF 15- titanium dioxide and zinc oxide cream

MOISTURIZER SPF 15 by

Drug Labeling and Warnings

MOISTURIZER SPF 15 by is a Otc medication manufactured, distributed, or labeled by Mineral Fusion Natural Brands. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Titanium Dioxide 3.5%
Zinc Oxide 3.5%

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 product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally 15 minutes before sun exposure
• Reapply:
  • after 40 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
• 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-sleeve shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor

Inactive ingredients

Mineral Water (Aqua), Aloe Barbadensis Leaf (Aloe Vera Gel) Juice1, Vegetable Glycerin, Caprylic/Capric Triglyceride, Zemea (Corn) Propanediol, Cetearyl Alcohol, Cetearyl Glucoside, Lecithin, Cetearyl Olivate, Sorbitan Olivate, Beeswax, Cocamidopropyl Betaine, Xanthan Gum, Palmitoyl Tripeptide-5, Calendula Officinalis Extract1, Camellia Sinensis (White Tea) Extract1, Chamomilla Recutita (Chamomile) Extract1, Kaolin, Citrus Grandis (Grapefruit) Seed Extract, Cucumis Sativus (Cucumber) Fruit Extract1, Gingko Biloba Extract, Gluconolactone, Glycrrhiza Glabra (Licorice) Extract, Isopropyl Palmitate, Isostearyl Palmitate, Tocopherol (Vitamin E), Sodium Benzoate, Natural Fragrance.

1 Certified Organic

Questions

Call 1-800-428-1668
Mon-Fri 8 a.m. – 5 p.m. MST

PRINCIPAL DISPLAY PANEL - 96 g Tube Carton

MINERAL FUSION
minerals on a mission

SPF 15 oil-free
moisturizer
with mattifying kaolin clay
BROAD SPECTRUM

helps control
oil and shine

SPF and peptide
age-defense

normal to oily skin types

MOISTURIZE

HYPO-ALLERGENIC. 100% VEGETARIAN.

Net Wt 3.4 oz / 96 g e

INGREDIENTS AND APPEARANCE

MOISTURIZER SPF 15 
titanium dioxide and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55789-3106
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.36 g  in 96 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	3.36 g  in 96 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	67.2 g  in 96 g
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PROPANEDIOL (UNII: 5965N8W85T)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
SORBITAN OLIVATE (UNII: MDL271E3GR)
YELLOW WAX (UNII: 2ZA36H0S2V)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
XANTHAN GUM (UNII: TTV12P4NEE)
PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
WHITE TEA (UNII: O0M3396E09)
CHAMOMILE (UNII: FGL3685T2X)
KAOLIN (UNII: 24H4NWX5CO)
CITRUS PARADISI SEED (UNII: 12F08874Y7)
CUCUMBER (UNII: YY7C30VXJT)
GINKGO (UNII: 19FUJ2C58T)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
LICORICE (UNII: 61ZBX54883)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
ISOSTEARYL PALMITATE (UNII: 9EHU0R7ER1)
TOCOPHEROL (UNII: R0ZB2556P8)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55789-3106-1	1 in 1 CARTON
1		96 g 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 FINAL	part352	08/01/2014

Labeler - Mineral Fusion Natural Brands (831770032)