MINERAL SPF 40 MOISTURIZER- zinc oxide and titanium dioxide lotion

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z), TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)
Available from:
Mineral Fusion brands
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
- 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
Authorization status:
OTC monograph not final
Authorization number:
55789-3109-2

MINERAL SPF 40 MOISTURIZER- zinc oxide and titanium dioxide lotion

Mineral Fusion brands

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Mineral SPF 40 Moisturizer

Drug Facts

Active Ingredients

Purpose

Titanium Dioxide 7.5%

Sunscreen

Zinc Oxide 5.0%

Sunscreen

Us es

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 Juice Caprylic/Capric Triglyceride,

Ethylhexyl Palmitate, Glyceryl Stearate, Cetyl Dimethicone, Vegetable Glycerin, Hexyl Laurate,

Polyglyceryl-4 Isostearate, Cetyl Alcohol, Myristyl Myristate, Simmondsia Chinensis (Jojoba) Seed

Butyrospermum Parkii (Shea) Butter

, Panthenol, Malachite Extract, Smithsonite Extract,

Rhodochrosite Extract, Hematite Extract, Palmitoyl Pentapeptide-3, Cucumis Sativus (Cucumber) Fruit

Extract

, Tocopherol Acetate, Allantoin, Soy Lecithin, Camellia Sinensis (Green Tea) Leaf Extract

Sodium PCA, Hyaluronic Acid, Chamomilla Recutita (Matricaria) Flower Extract

, Rosmarinus

Officinalis (Rosemary) Leaf Oil, Calendula Officinalis Flower Extract

, Cedrus Atlantica (Cedarwood)

Bark Oil, Ginkgo Biloba Leaf Extract

, Alaria Esculenta (Sea Kelp) Extract, Pelargonium Graveolens

(Geranium) Flower Oil, Magnesium Aluminum Silicate, Benzyl Alcohol, Ethylhexylglycerin,

Phenoxyethanol, Natural Fragrance.

Ques tions

Call 1-800-428-1668

Mon-Fri 8 a.m. – 5 p.m. PST

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

Certified Organic

MINERAL SPF 40 MOISTURIZER

zinc oxide and titanium dioxide lotion

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:5578 9 -310 9

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)

ZINC OXIDE

5 g in 10 0 mL

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP) (TITANIUM DIOXIDE - UNII:15FIX9 V2JP)

TITANIUM DIOXIDE

7.5 g in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ETHYLHEXYL PALMITATE (UNII: 28 6 59 9 330 9 )

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

CETYL DIMETHICO NE 2 5 (UNII: U4AS1BW4ZB)

GLYCERIN (UNII: PDC6 A3C0 OX)

HEXYL LAURATE (UNII: 4CG9 F9 W0 1Q)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

PO LYGLYCERYL-4 ISO STEARATE (UNII: 8 20 DPX33S7)

MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9 H2L21V7U)

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

SHEA BUTTER (UNII: K49 155WL9 Y)

PANTHENO L (UNII: WV9 CM0 O6 7Z)

MAGNESIUM ASPARTATE (UNII: R17X8 20 ROL)

ZINC GLUCO NATE (UNII: U6 WSN5SQ1Z)

JO JO BA O IL (UNII: 724GKU717M)

TO CO PHERO L (UNII: R0 ZB2556 P8 )

CO PPER GLUCO NATE (UNII: RV8 23G6 G6 7)

HYALURO NATE SO DIUM (UNII: YSE9 PPT4TH)

PALMITO YL PENTAPEPTIDE-4 (UNII: KK18 1SM5JG)

ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

ALLANTO IN (UNII: 344S277G0 Z)

SO DIUM PYRRO LIDO NE CARBO XYLATE (UNII: 46 9 OTG57A2)

LECITHIN, SO YBEAN (UNII: 1DI56 QDM6 2)

MAGNESIUM ALUMINUM SILICATE (UNII: 6 M3P6 4V0 NC)

GREEN TEA LEAF (UNII: W2ZU1RY8 B0 )

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

Mineral Fusion brands

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:5578 9 -310 9 -2

1 in 1 CARTON

0 9 /17/20 19

1

6 0 mL in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH NOT FINAL part352

12/10 /20 12

Labeler -

Mineral Fusion brands (831770032)

Revised: 9/2019

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