MINUS-SOL FACIAL SUN PROTECTION SUNSCREEN BROAD SPECTRUM SPF 30 PLUS WHITE- octinoxate, titanium dioxide, zinc oxide cream

Minus-Sol Facial Sun Protection Sunscreen Broad Spectrum SPF 30 Plus White by

Drug Labeling and Warnings

Minus-Sol Facial Sun Protection Sunscreen Broad Spectrum SPF 30 Plus White by is a Otc medication manufactured, distributed, or labeled by Aledian Corporation, Pan Rajdhevee Group Public Company Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Octyl Methoxycinnamate 4%
Titanium Dioxide  5%
Zinc Oxide 5%

Purpose

Sunscreen

Use

• 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

When using this product

• keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

• if rash occuurs
  

Keep out of reach of children.

If swallowed, get medical help or contact Poison Control Center right away.

Directions:

For sunscreen use

• Apply liberally 15 minutes before sun exposure
• Children under 6 months of age: Ask a doctor
• Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value 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
• Reapply
• After 80 minutes of swimming or sweating
• Immediately after towel drying
• At least every 2 hours
  

Other information

• Protect the product in this container from excessive heat and direct sun
  

Inactive ingredients

ALUMINA, C9-15 FLUCROALCOHOL PHOSPHATES, CETYL PPG/PPG-10/1 DIMETHICONE, CHITOSAN, CYCLOPENTASILOXANE, DISOPROPYLOMER DUNCLEATE, DIMETHOCONEVINYL DIMETHICONE CROSSPOLYMER, HEXYL LAURATE, IRON OXIDE BLACK, IRON OXIDE RED, IRON OXIDE YELLOW METHYLPARABEN, FRAGRANCE, POLYGLYCERY-4 ISOSTEARATE, PROPYLPARABEN, PHEXACECENE COPOLYMER.

Minus-sol

Formulated with the newest technological advancement; this ultra-fine, light, silky smooth, very water resistant facial cream provides long-lasting double UV protection. It is an oil free formulation that contains an inactive ingredient (Enhanced Chitosan) which results in a smooth silky feeling.

Distributed by:
Aledian Corporation
Miami Beach, FL 33140 USA

Made in Thailand

To report a serious adverse event
Contact:
1.866.Minus.Sol

www.MinusSol.com

PRINCIPAL DISPLAY PANEL

SPF 30+ Minus-Sol
Facial Sun Protection Sunscreen Broad Spectrum SPF 30+
Silky Smooth Cream Oil Free
Water Resistant (80 Minutes)
Dermatologically Tested
White
Net Wt. 1.76 oz (50g)

Product Labels

INGREDIENTS AND APPEARANCE

MINUS-SOL FACIAL SUN PROTECTION SUNSCREEN BROAD SPECTRUM SPF 30 PLUS WHITE 
octinoxate, titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68411-4057
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	4 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM OXIDE (UNII: LMI26O6933)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68411-4057-3	1 g in 1 TUBE
2	NDC: 68411-4057-1	25 g in 1 TUBE
3	NDC: 68411-4057-2	50 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/22/2012

Labeler - Aledian Corporation (140038410)

Registrant - Aledian Corporation (140038410)

Establishment
Name	Address	ID/FEI	Business Operations
Pan Rajdhevee Group Public Company Limited		671668125	manufacture(68411-4057)