MINERAL SPF 40 MOISTURIZER- zinc oxide and titanium dioxide lotion

Mineral SPF 40 Moisturizer by

Drug Labeling and Warnings

Mineral SPF 40 Moisturizer by is a Otc medication manufactured, distributed, or labeled by Mineral Fusion brands. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Titanium Dioxide 7.5%	Sunscreen
Zinc Oxide 5.0%	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 to clean skin 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 (Aloe Vera) Leaf Juice1 Caprylic/Capric Triglyceride, Ethylhexyl Palmitate, Glyceryl Stearate, Cetyl Dimethicone, Vegetable Glycerin, Hexyl Laurate, Polyglyceryl-4 Isostearate, Cetyl Alcohol, Myristyl Myristate, Simmondsia Chinensis (Jojoba) Seed Oil1 Butyrospermum Parkii (Shea) Butter1, Panthenol, Malachite Extract, Smithsonite Extract, Rhodochrosite Extract, Hematite Extract, Palmitoyl Pentapeptide-3, Cucumis Sativus (Cucumber) Fruit Extract1, Tocopherol Acetate, Allantoin, Soy Lecithin, Camellia Sinensis (Green Tea) Leaf Extract1, Sodium PCA, Hyaluronic Acid, Chamomilla Recutita (Matricaria) Flower Extract1, Rosmarinus Officinalis (Rosemary) Leaf Oil, Calendula Officinalis Flower Extract1, Cedrus Atlantica (Cedarwood) Bark Oil, Ginkgo Biloba Leaf Extract1, Alaria Esculenta (Sea Kelp) Extract, Pelargonium Graveolens (Geranium) Flower Oil, Magnesium Aluminum Silicate, Benzyl Alcohol, Ethylhexylglycerin, Phenoxyethanol, Natural Fragrance.

1 Certified Organic

Questions

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

SPL UNCLASSIFIED SECTION

Dist. by Mineral Fusion
Petaluma, CA 94954 USA

PRINCIPAL DISPLAY PANEL - 96 g Tube Carton

Mineral SPF 40
Moisturizer

Nourishing Hydration
with Shea Butter
Broad Spectrum

MINERAL
FUSION®

Making
Beauty
Healthy®

Net Wt 3.4 oz e 96 g

INGREDIENTS AND APPEARANCE

MINERAL SPF 40 MOISTURIZER 
zinc oxide and titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55789-3109
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	5 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	7.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)
GLYCERIN (UNII: PDC6A3C0OX)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETYL ALCOHOL (UNII: 936JST6JCN)
SHEA BUTTER (UNII: K49155WL9Y)
PANTHENOL (UNII: WV9CM0O67Z)
MAGNESIUM ASPARTATE (UNII: R17X820ROL)
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)
JOJOBA OIL (UNII: 724GKU717M)
TOCOPHEROL (UNII: R0ZB2556P8)
COPPER GLUCONATE (UNII: RV823G6G67)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ALLANTOIN (UNII: 344S277G0Z)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55789-3109-2	1 in 1 CARTON	09/17/2019
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 NOT FINAL	part352	12/10/2012

Labeler - Mineral Fusion brands (831770032)