SPF 16 AGE-DEFYING TREATMENT SERUM- titanium dioxide and zinc oxide cream

SPF 16 AGE-DEFYING TREATMENT SERUM by

Drug Labeling and Warnings

SPF 16 AGE-DEFYING TREATMENT SERUM 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 Juice1, Octyl Palmitate, Vegetable Glycerin, Soy Lecithin, Helianthus Annuus (Sunflower) Seed Oil1, Palmitoyl Oligopeptide, Palmitoyl Tetrapeptide-7, a-Lipoic Acid, Theobroma Cacao (Cocoa) Butter, Caprylic/Capric Triglyceride, Polysorbate 20, Olea Europaea (Olive) Oil1, Gingko Biloba Extract, Camellia Sinensis (Green Tea) Extract1, Glycrrhiza Glabra (Licorice) Extract, Punica Granatum (Pomegranate) Extract1, Sesamum Indicum (Sesame) Oil, Tocopheryl Acetate (Vitamin E), Ascorbyl Palmitate, Ethylhexylglycerin, Prunus Amygdalus (Sweet Almond) Oil1, Phenoxyethanol, Natural Fragrance.

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
age-defying
treatment
serum
with alpha lipoic acid

BROAD SPECTRUM

concentrated
wrinkle-defense
serum

dual peptide and
SPF defense

all skin types

TREAT

HYPO-ALLERGENIC. 100% VEGAN.

Net Wt 1.0 oz / 28 g e

INGREDIENTS AND APPEARANCE

SPF 16 AGE-DEFYING TREATMENT SERUM 
titanium dioxide and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55789-3104
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)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERIN (UNII: PDC6A3C0OX)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SUNFLOWER OIL (UNII: 3W1JG795YI)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
.ALPHA.-LIPOIC ACID (UNII: 73Y7P0K73Y)
COCOA BUTTER (UNII: 512OYT1CRR)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
OLIVE OIL (UNII: 6UYK2W1W1E)
GINKGO (UNII: 19FUJ2C58T)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
LICORICE (UNII: 61ZBX54883)
POMEGRANATE (UNII: 56687D1Z4D)
SESAME OIL (UNII: QX10HYY4QV)
TOCOPHEROL (UNII: R0ZB2556P8)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ALMOND OIL (UNII: 66YXD4DKO9)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55789-3104-1	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)