Solar Stick™ Spf 40

Solar Stick™ Spf 40
SPL v2
SPL
SPL Set ID 6ce602bb-c1f4-43c1-ae61-0f05d7952db3
Route
TOPICAL
Published
Effective Date 2023-09-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (81 mg) Zinc Oxide (60 mg)
Inactive Ingredients
High Density Polyethylene Dimethicone Butyloctyl Salicylate Petrolatum Shea Butter Alkyl (c12-15) Benzoate Medium-chain Triglycerides Methyl Dihydroabietate 2-ethylhexyl Acrylate, Methacrylate, Methyl Methacrylate, Or Butyl Methacrylate/hydroxypropyl Dimethicone Copolymer (30000-300000 Mw) Octyldodecanol Tetrahexyldecyl Ascorbate Tocopherol Behenyl Olivate Aluminum Hydroxide Stearic Acid Sorbitan Sesquioleate Glyceryl Isostearate Polyhydroxystearic Acid (2300 Mw) Citric Acid Monohydrate Benzylidene Dimethoxydimethylindanone

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 8.1% Sunscreen
Zinc Oxide 6% 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

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

Polyethylene, Dimethicone, Butyloctyl Salicylate, Petrolatum, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Methyl Dihydroabietate, Acrylates/ Ethylhexyl Acrylate/Dimethicone Methacrylate Copolymer, Octyldodecanol, Tetrahexyldecyl Ascorbate (Vitamin C), Tocopherol (Vitamin E), Behenyl Olivate, Aluminum Hydroxide, Stearic Acid, Sorbitan Sesquioleate, Glyceryl Isostearate, Polyhydroxystearic Acid, Citric Acid, Benzylidene Dimethoxydimethylindanone

Principal Display Panel 17 G Tube Carton

MDSOLARSCIENCES ®

SOLAR STICK™

Broad Spectrum SPF 40

Water Resistant (80 Min)

Mineral Sunscreen

SPF 40

Sheer, lightweight

portable protection

DERMATOLOGIST DEVELOPED

With Vitamins C + E

0.6 OZ / 17 G


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 8.1% Sunscreen
Zinc Oxide 6% 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

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

Polyethylene, Dimethicone, Butyloctyl Salicylate, Petrolatum, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Methyl Dihydroabietate, Acrylates/ Ethylhexyl Acrylate/Dimethicone Methacrylate Copolymer, Octyldodecanol, Tetrahexyldecyl Ascorbate (Vitamin C), Tocopherol (Vitamin E), Behenyl Olivate, Aluminum Hydroxide, Stearic Acid, Sorbitan Sesquioleate, Glyceryl Isostearate, Polyhydroxystearic Acid, Citric Acid, Benzylidene Dimethoxydimethylindanone

Principal Display Panel 17 G Tube Carton (PRINCIPAL DISPLAY PANEL - 17 G Tube Carton)

MDSOLARSCIENCES ®

SOLAR STICK™

Broad Spectrum SPF 40

Water Resistant (80 Min)

Mineral Sunscreen

SPF 40

Sheer, lightweight

portable protection

DERMATOLOGIST DEVELOPED

With Vitamins C + E

0.6 OZ / 17 G


Advanced Ingredient Data


Raw Label Data

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