SPF 15 BRIGHTENING MOISTURIZER- zinc oxide cream

SPF 15 BRIGHTENING MOISTURIZER by

Drug Labeling and Warnings

SPF 15 BRIGHTENING MOISTURIZER 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

Zinc Oxide 10.5%

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), Vegetable Glycerin, Cetearyl Alcohol, Stearic Acid, Chondrus Crispus Extract, Glyceryl Stearate, Cocos Nucifera (Coconut) Oil1, Thymus Vulgaris (Thyme) Extract1, Linum Usitatissimum (Flax) Seed Oil, Rosemary Officinalis (Rosemary) Leaf Oil1, Butyrospermum Parkii (Shea Butter)1, Ginkgo Biloba Leaf Extract, Rosa Canina (Rosehip) Oil1, Chamomilla Recutita (Matricaria) Flower Extract, Olea Europaea (Olive) Leaf Extract, Cucumis Sativus (Cucumber) Fruit Extract, Borago Officinalis (Borage) Seed Oil, Ascorbic Acid (Vitamin C), Calendula Officinalis Flower Extract1, Methylcellulose, Pentapeptide, Camellia Sinensis Leaf Extract, Allantoin, Cedrus Atlantica (Cedarwood) Bark Oil, Pelargonium Graveolens (Geranium) Flower Oil, Citrus Aurantium Dulcis (Orange) Fruit Oil, Panthenol (Vitamin B5), Hydrolyzed Jojoba Esters, Sodium Hyaluronate, Tocopherol (Vitamin E), Ethylhexylglycerin, Phenethyl Alcohol.
May Contain: Mica, Titanium Dioxide, Iron Oxides.

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 brightening
moisturizer
with restoring vitamin c
BROAD SPECTRUM

softly illuminates and
restores radiance

SPF and peptide
age-defense

all skin types

MOISTURIZE
HYPO-ALLERGENIC. 100% VEGAN.

Net Wt 3.4 oz / 96 g e

INGREDIENTS AND APPEARANCE

SPF 15 BRIGHTENING MOISTURIZER 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55789-2905
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	10.8 g  in 96 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	67.2 g  in 96 g
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
STEARIC ACID (UNII: 4ELV7Z65AP)
CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
COCONUT OIL (UNII: Q9L0O73W7L)
THYME (UNII: CW657OBU4N)
LINSEED OIL (UNII: 84XB4DV00W)
ROSEMARY OIL (UNII: 8LGU7VM393)
SHEA BUTTER (UNII: K49155WL9Y)
GINKGO (UNII: 19FUJ2C58T)
ROSA CANINA FLOWER OIL (UNII: DUY7M48I1T)
CHAMOMILE (UNII: FGL3685T2X)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
CUCUMBER (UNII: YY7C30VXJT)
BORAGE OIL (UNII: F8XAG1755S)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
METHYLCELLULOSE (400 MPA.S) (UNII: O0GN6F9B2Y)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ALLANTOIN (UNII: 344S277G0Z)
CEDRUS ATLANTICA BARK OIL (UNII: ZX5QRE4U60)
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
ORANGE (UNII: 5EVU04N5QU)
PANTHENOL (UNII: WV9CM0O67Z)
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
TOCOPHEROL (UNII: R0ZB2556P8)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55789-2905-1	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)