SUNSECT INSECT REPELLENT SUNSCREEN- octinoxate, oxybenzone, octisalate lotion

Sunsect Insect Repellent Sunscreen by

Drug Labeling and Warnings

Sunsect Insect Repellent Sunscreen by is a Otc medication manufactured, distributed, or labeled by Iguana LLC, Solo Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Octinoxate: 7.5%
Oxybenzone: 6%
Octisalate: 5%

Purpose

Sunscreen

Uses

• helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging.  This product has been shown only to help prevent sunbrun, not skin cancer or early skin aging.

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

Directions

• apply liberally 15 minutes before sun exposure
• children under 6 months of age: Ask a doctor
• 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

acrylates/C10-30 alkyl acrylate copolymer, carrageenan, carboxy vinyl polymer, cetostearyl alcohol, diazolidinyl urea, diethanolamine cetyl phosphate, methylparaben, propylparaben, propylene glycol, tocopheryl acetate (Vitamin E), tricontanyl povidone, water

Comments/Questions?

1-229-228-0980

Principal Display Panel

INGREDIENTS AND APPEARANCE

SUNSECT INSECT REPELLENT SUNSCREEN 
octinoxate, oxybenzone, octisalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57595-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	6 g  in 100 g
DIETHYLTOLUAMIDE (UNII: FB0C1XZV4Y) (DIETHYLTOLUAMIDE - UNII:FB0C1XZV4Y)	DIETHYLTOLUAMIDE	20 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
Carrageenan (UNII: 5C69YCD2YJ)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIETHANOLAMINE CETYL PHOSPHATE (UNII: 4UG0316V9S)
TRICONTANYL POVIDONE (UNII: N0SS3Q238D)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
CITRONELLA OIL (UNII: QYO8Q067D0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57595-001-01	59 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2015
2	NDC: 57595-001-02	118 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2015
3	NDC: 57595-001-03	3672 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/01/2015
4	NDC: 57595-001-04	50 in 1 BOX	06/01/2015
4		9 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/01/2015

Labeler - Iguana LLC (109358551)

Establishment
Name	Address	ID/FEI	Business Operations
Solo Laboratories, Inc.		005126784	manufacture(57595-001) , pack(57595-001) , label(57595-001)