SUNSECT INSECT REPELLENT SUNSCREEN- octinoxate, oxybenzone, octisalate lotion 
Iguana LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active Ingredients

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

Purpose

Sunscreen

Uses

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

Other Information

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

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image of 4 oz back panel label

image of 4 oz front panel label

image of 2 oz back panel label

image of 2 oz front panel labelimage of 1-gallon labelimage of 50-count carton label

SUNSECT INSECT REPELLENT SUNSCREEN 
octinoxate, oxybenzone, octisalate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57595-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 g  in 100 g
DIETHYLTOLUAMIDE (UNII: FB0C1XZV4Y) (DIETHYLTOLUAMIDE - UNII:FB0C1XZV4Y) DIETHYLTOLUAMIDE20 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57595-001-0159 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2015
2NDC:57595-001-02118 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2015
3NDC:57595-001-033672 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/01/2015
4NDC:57595-001-0450 in 1 BOX06/01/2015
49 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/01/2015
Labeler - Iguana LLC (109358551)
Establishment
NameAddressID/FEIBusiness Operations
Solo Laboratories, Inc.005126784manufacture(57595-001) , pack(57595-001) , label(57595-001)

Revised: 6/2015
Document Id: bfad4f43-3418-4a2a-9acf-483a688abbb0
Set id: 6ccdc093-8af9-4bd8-84b0-f229fccd2f1c
Version: 2
Effective Time: 20150620
 
Iguana LLC