Mineral Moisture Defense

Mineral Moisture Defense
SPL v3
SPL
SPL Set ID 960ad8e2-34cb-45e1-ac9d-a5a4b16e9287
Route
TOPICAL
Published
Effective Date 2018-11-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (2.7 g) Zinc Oxide (1.3 g)
Inactive Ingredients
Dimethicone Medium-chain Triglycerides Dimethicone/diene Dimethicone Crosspolymer Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Butyloctyl Salicylate Glyceryl Isostearate Polyester-8 (1400 Mw, Cyanodiphenylpropenoyl Capped) Polysilicone-15 Behenic Acid Green Tea Leaf Caprooyl Tetrapeptide-3 N-hexanoylsphingosine Ceramide Ap Ceramide 9 3-dehydroxy Ceramide 1 Ceramide Np Ceramide Ng Cetyl Alcohol Cholesterol Glycerin Ferric Oxide Red Peg/ppg-18/18 Dimethicone Pomegranate Juice Silicon Dioxide Tetrahexyldecyl Ascorbate .alpha.-tocopherol Acetate Triethoxycaprylylsilane Cranberry

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-01-01

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses
  • Helps prevent sunburn
  • If used with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if rash occurs

Section 50567-7

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1

Do not use on damaged or broken skin

Section 55105-1
Active Ingredients Purpose
Titanium Dioxide 2% Sunscreen
Zinc Oxide 17% Sunscreen
Warnings

For external use only

Inactives

Dimethicone, Caprylic/Capric Triglyceride, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Butyloctyl Salicylate, Glyceryl Isostearate, Polyester-8, Polysilicone-15, Behenic Acid, Camelia Sinensis Leaf Extract, Caprooyl Phytosphingosine, Ceramide AP, Ceramide EOP, Ceramide EOS, Ceramide NP, Ceramide NS, Ceteareth-25, Cetyl Alcohol, Cholesterol, Glycerin, Iron Oxides, PEG/PPG-18/18 Dimethicone, Punica Granatum Extract, Silica, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Triethoxycaprylysilane, Vaccinum Macrocarpon (Cranberry) Fruit Extract

Directions
  • Apply liberally 15 minutes before sun exposure
  • Reapply:
    • -
      After 80 minutes of swimming or sweating
    • -
      Immediately after towel drying
    • -
      At least every 2 hours
    • -
      Children under 6 months: Ask a doctor
  • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with Broad Spectrum SPF of 15 or higher and other sun protection measures including:
    • -
      Limit time in the sun, especially from 10a.m. – 2p.m.
    • -
      Wear long-sleeved shirts, pants, hats and sunglasses
Other Information

Shake well. Rub in well.

  • Protect the product in this container from excessive heat and direct sunlight
  • May stain some fabrics
  • You may report serious adverse reactions to:

    Report Reaction, LLC. PO Box 22, Plainsboro, NJ 08536-0222
Principal Display Panel 113 G Tube Carton

MDSolarSciences

50

MINERAL

MOISTURE

DEFENSE

body

BROAD SPECTRUM

SPF 50

UVA-UVB SUNSCREEN

+R

enhanced with

ProVention-R™

developed & approved

by Dermatologists

Water resistant (80 minutes)

Non-comedogenic – won't clog pores

Family Formula

sun care

Net Wt. 113 g - 4 Oz.


Structured Label Content

Uses
  • Helps prevent sunburn
  • If used with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs

Section 50567-7 (50567-7)

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Section 55105-1 (55105-1)
Active Ingredients Purpose
Titanium Dioxide 2% Sunscreen
Zinc Oxide 17% Sunscreen
Warnings

For external use only

Inactives

Dimethicone, Caprylic/Capric Triglyceride, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Butyloctyl Salicylate, Glyceryl Isostearate, Polyester-8, Polysilicone-15, Behenic Acid, Camelia Sinensis Leaf Extract, Caprooyl Phytosphingosine, Ceramide AP, Ceramide EOP, Ceramide EOS, Ceramide NP, Ceramide NS, Ceteareth-25, Cetyl Alcohol, Cholesterol, Glycerin, Iron Oxides, PEG/PPG-18/18 Dimethicone, Punica Granatum Extract, Silica, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Triethoxycaprylysilane, Vaccinum Macrocarpon (Cranberry) Fruit Extract

Directions
  • Apply liberally 15 minutes before sun exposure
  • Reapply:
    • -
      After 80 minutes of swimming or sweating
    • -
      Immediately after towel drying
    • -
      At least every 2 hours
    • -
      Children under 6 months: Ask a doctor
  • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with Broad Spectrum SPF of 15 or higher and other sun protection measures including:
    • -
      Limit time in the sun, especially from 10a.m. – 2p.m.
    • -
      Wear long-sleeved shirts, pants, hats and sunglasses
Other Information

Shake well. Rub in well.

  • Protect the product in this container from excessive heat and direct sunlight
  • May stain some fabrics
  • You may report serious adverse reactions to:

    Report Reaction, LLC. PO Box 22, Plainsboro, NJ 08536-0222
Principal Display Panel 113 G Tube Carton (PRINCIPAL DISPLAY PANEL - 113 g Tube Carton)

MDSolarSciences

50

MINERAL

MOISTURE

DEFENSE

body

BROAD SPECTRUM

SPF 50

UVA-UVB SUNSCREEN

+R

enhanced with

ProVention-R™

developed & approved

by Dermatologists

Water resistant (80 minutes)

Non-comedogenic – won't clog pores

Family Formula

sun care

Net Wt. 113 g - 4 Oz.


Advanced Ingredient Data


Raw Label Data

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