SOLAR SPF 40 BROAD SPECTRUM SPF 40 WATER RESISTANT (80 MIN) MINERAL SUNCREEN- titanium dioxide and zinc oxide stick

Solar SPF 40 by

Drug Labeling and Warnings

Solar SPF 40 by is a Otc medication manufactured, distributed, or labeled by MDSolarSciences. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Titanium Dioxide 8.1%	Sunscreen
Zinc Oxide 6%	Sunscreen

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.

Warnings

For external use only

Do not use on damaged or broken skin

Stop use and ask a doctor if rash occurs

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

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

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

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY
MDSOLARSCIENCES CORP.
GREENS FARMS, CT 06838

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

INGREDIENTS AND APPEARANCE

SOLAR SPF 40  BROAD SPECTRUM SPF 40 WATER RESISTANT (80 MIN) MINERAL SUNCREEN
titanium dioxide and zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49358-577
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	81 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	60 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
PETROLATUM (UNII: 4T6H12BN9U)
SHEA BUTTER (UNII: K49155WL9Y)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
2-ETHYLHEXYL ACRYLATE, METHACRYLATE, METHYL METHACRYLATE, OR BUTYL METHACRYLATE/HYDROXYPROPYL DIMETHICONE COPOLYMER (30000-300000 MW) (UNII: S7ZA3CCJ4M)
OCTYLDODECANOL (UNII: 461N1O614Y)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
TOCOPHEROL (UNII: R0ZB2556P8)
BEHENYL OLIVATE (UNII: NGS1GGK4GW)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
BENZYLIDENE DIMETHOXYDIMETHYLINDANONE (UNII: 75HIF3C97L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49358-577-01	1 in 1 CARTON	07/01/2023
1		17 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	07/01/2023

Labeler - MDSolarSciences (013647301)