Mineral Tinted Crème Spf 30

Mineral Tinted Crème Spf 30
SPL v2
SPL
SPL Set ID adcd6881-fa25-4312-95e5-5b47102aa6b9
Route
TOPICAL
Published
Effective Date 2023-09-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (20 mg) Zinc Oxide (170 mg)
Inactive Ingredients
Dimethicone Medium-chain Triglycerides Dimethicone/diene Dimethicone Crosspolymer Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Butyloctyl Salicylate Glyceryl Isostearate Polysilicone-15 Tetrahexyldecyl Ascorbate Green Tea Leaf Pomegranate Juice Cranberry Silicon Dioxide Polyhydroxystearic Acid (2300 Mw)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-07-01

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 doctorif rash occurs

Section 50567-7

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

Section 50570-1

Do not useon 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 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 611, Pompton Plains, NJ 07444
Inactive Ingredients

Dimethicone, Caprylic/Capric Triglyceride, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Butyloctyl Salicylate, Glyceryl Isostearate, Polysilicone-15, Tetrahexyldecyl Ascorbate (Vitamin C), Camellia Sinensis Leaf Extract (Green Tea), Punica Granatum Extract (Pomegranate), Vaccinium Macrocarpon (Cranberry) Fruit Extract, Silica, Polyhydroxystearic Acid, May Contain: (CI 77891, CI 77492, CI 77491, CI 77499)

Principal Display Panel 50 Ml Tube Carton

MDSOLARSCIENCES ®

MINERAL

TINTED CRÈME

Broad Spectrum SPF 30

Water Resistant (80 Min)

100% Mineral Sunscreen

SPF 30

Natural Protection

with a Sheer, Matte Finish

TINTED

DERMATOLOGIST

DEVELOPED

CRANBERRY

GREEN TEA

POMEGRANATE

VITAMIN C

1.7 FL OZ / 50 ML


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 doctorif rash occurs

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)

Do not useon 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 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 611, Pompton Plains, NJ 07444
Inactive Ingredients

Dimethicone, Caprylic/Capric Triglyceride, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Butyloctyl Salicylate, Glyceryl Isostearate, Polysilicone-15, Tetrahexyldecyl Ascorbate (Vitamin C), Camellia Sinensis Leaf Extract (Green Tea), Punica Granatum Extract (Pomegranate), Vaccinium Macrocarpon (Cranberry) Fruit Extract, Silica, Polyhydroxystearic Acid, May Contain: (CI 77891, CI 77492, CI 77491, CI 77499)

Principal Display Panel 50 Ml Tube Carton (PRINCIPAL DISPLAY PANEL - 50 ML Tube Carton)

MDSOLARSCIENCES ®

MINERAL

TINTED CRÈME

Broad Spectrum SPF 30

Water Resistant (80 Min)

100% Mineral Sunscreen

SPF 30

Natural Protection

with a Sheer, Matte Finish

TINTED

DERMATOLOGIST

DEVELOPED

CRANBERRY

GREEN TEA

POMEGRANATE

VITAMIN C

1.7 FL OZ / 50 ML


Advanced Ingredient Data


Raw Label Data

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