SPF 16 BRIGHTENING- zinc oxide cream

SPF 16 BRIGHTENING by

Drug Labeling and Warnings

SPF 16 BRIGHTENING 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, Cocos Nucifera (Coconut) Oil1, Butyrospermum Parkii (Shea Butter) Fruit1, Thymus Vulgaris (Thyme) Extract1, Cetearyl Alcohol, Glyceryl Stearate, Chondrus Crispus Extract, Triisostearyl Citrate, Linum Usitatissimum (Flax) Seed Oil1, Rosemary Officinalis (Rosemary) Leaf Oil1, Persea Gratissima (Avocado) Butter, Ginkgo Biloba Leaf Extract1, Rosa Canina (Rosehip) Oil1, Chamomilla Recutita (Matricaria) Flower Extract1, Olea Europaea (Olive) Leaf Extract1, Cucumis Sativus (Cucumber) Fruit Extract, Aloe Barbadensis Leaf Oil1, Borago Officinalis (Borage) Seed Oil1, Calendula Officinalis Flower Extract1, Pentapeptide, Methylcellulose, Camellia Sinensis Leaf Extract1, Cedrus Atlantica (Cedarwood) Bark Oil1, Pelargonium Graveolens (Geranium) Flower Oil, Panthenol (Vitamin B5), Ascorbic Acid (Vitamin C), Sodium Hyaluronate, Tocopherol (Vitamin E), Allantoin, Mica, Ethylhexylglycerin, Phenethyl Alcohol. May contain: 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 - 28 g Tube Carton

MINERAL FUSION
minerals on a mission

SPF 16
brightening
eye cream
with firming rosehip oil
BROAD SPECTRUM

brightens, plumps,
and firms

SPF and peptide
age-defense

all skin types

TREAT

HYPO-ALLERGENIC. 100% VEGAN.

Net Wt 1.0 oz / 28 g e

INGREDIENTS AND APPEARANCE

SPF 16 BRIGHTENING 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55789-2901
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2.94 g  in 28 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	19.6 g  in 28 g
GLYCERIN (UNII: PDC6A3C0OX)
COCONUT OIL (UNII: Q9L0O73W7L)
SHEA BUTTER (UNII: K49155WL9Y)
THYME (UNII: CW657OBU4N)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)
TRIISOSTEARYL CITRATE (UNII: 50XT325OOH)
LINSEED OIL (UNII: 84XB4DV00W)
ROSEMARY OIL (UNII: 8LGU7VM393)
AVOCADO SEED BUTTER (UNII: TSD0N1V8MB)
GINKGO (UNII: 19FUJ2C58T)
ROSA CANINA FLOWER OIL (UNII: DUY7M48I1T)
CHAMOMILE (UNII: FGL3685T2X)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
CUCUMBER (UNII: YY7C30VXJT)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BORAGE OIL (UNII: F8XAG1755S)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
METHYLCELLULOSE (400 MPA.S) (UNII: O0GN6F9B2Y)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CEDRUS ATLANTICA BARK OIL (UNII: ZX5QRE4U60)
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
PANTHENOL (UNII: WV9CM0O67Z)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
TOCOPHEROL (UNII: R0ZB2556P8)
ALLANTOIN (UNII: 344S277G0Z)
MICA (UNII: V8A1AW0880)
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: 55789-2901-1	1 in 1 CARTON
1		28 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)