Mineral Beauty Balm

Mineral Beauty Balm
SPL v4
SPL
SPL Set ID 7c3c978d-27b9-49ec-85a0-b2f2e6dc8272
Route
TOPICAL
Published
Effective Date 2020-01-27
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 Dimethicone/diene Dimethicone Crosspolymer Medium-chain Triglycerides Glyceryl Isostearate Polyhydroxystearic Acid (2300 Mw) Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Silicon Dioxide Butyloctyl Salicylate Polysilicone-15 Tetrahexyldecyl Ascorbate Peg/ppg-18/18 Dimethicone Triethoxycaprylylsilane Ferric Oxide Red Caffeine Niacinamide Ubidecarenone .alpha.-tocopherol Acetate Squalane Green Tea Leaf Cranberry Pomegranate Juice

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-04-01

Description

Drug Facts


Medication Information

Description

Drug Facts

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
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

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 10 a.m. – 2 p.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 reaction to: Report Reaction, LLC. PO Box 22, Plainsboro, NJ 08536-0222
Inactive Ingredients

Dimethicone, Dimethicone Crosspolymer, Caprylic/Capric Triglyceride, Glyceryl Isostearate, Polyhydroxystearic Acid, Dimethicone/Vinyl Dimethicone Crosspolymer, Silica, Butyloctyl Salicylate, Polysilicone-15, Tetrahexyldecyl Ascorbate, PEG/PPG-18/18 Dimethicone, Triethoxycaprylylsilane, Iron Oxide, Caffeine, Niacinamide, Ubiquinone, Tocopheryl Acetate, Squalane, Camellia Sinensis (Green Tea) Extract, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Punica Granatum (Pomegranate) Extract.

Principal Display Panel 35 G Tube Carton Medium/dark

MDSolarSciences

50

MD CRÈME

MINERAL

BEAUTY BALM

medium • dark

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

sun repair

Net Wt. 35 g - 1.23 Oz.

Principal Display Panel 35 G Tube Carton Light/medium

MDSolarSciences

50

MD CRÈME

MINERAL

BEAUTY BALM

light • medium

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

sun repair

Net Wt. 35 g - 1.23 Oz.


Structured Label Content

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
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

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 10 a.m. – 2 p.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 reaction to: Report Reaction, LLC. PO Box 22, Plainsboro, NJ 08536-0222
Inactive Ingredients

Dimethicone, Dimethicone Crosspolymer, Caprylic/Capric Triglyceride, Glyceryl Isostearate, Polyhydroxystearic Acid, Dimethicone/Vinyl Dimethicone Crosspolymer, Silica, Butyloctyl Salicylate, Polysilicone-15, Tetrahexyldecyl Ascorbate, PEG/PPG-18/18 Dimethicone, Triethoxycaprylylsilane, Iron Oxide, Caffeine, Niacinamide, Ubiquinone, Tocopheryl Acetate, Squalane, Camellia Sinensis (Green Tea) Extract, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Punica Granatum (Pomegranate) Extract.

Principal Display Panel 35 G Tube Carton Medium/dark (PRINCIPAL DISPLAY PANEL - 35 g Tube Carton - Medium/Dark)

MDSolarSciences

50

MD CRÈME

MINERAL

BEAUTY BALM

medium • dark

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

sun repair

Net Wt. 35 g - 1.23 Oz.

Principal Display Panel 35 G Tube Carton Light/medium (PRINCIPAL DISPLAY PANEL - 35 g Tube Carton - Light/Medium)

MDSolarSciences

50

MD CRÈME

MINERAL

BEAUTY BALM

light • medium

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

sun repair

Net Wt. 35 g - 1.23 Oz.


Advanced Ingredient Data


Raw Label Data

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