OP DARK FORMULA XTREME TANNING 4- octinoxate, octisalate lotion

OP Dark Formula Xtreme Tanning 4 by

Drug Labeling and Warnings

OP Dark Formula Xtreme Tanning 4 by is a Otc medication manufactured, distributed, or labeled by Sun & Skin Care Research, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Octinoxate 3.0%
Octisalate 2.0%

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 prevent sunburn, not skin cancer or early skin aging.

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 the reach of children.  If swallowed, get medical help or call a poison control center right away.

Directions

• apply evenly and liberally to all exposed areas 15 minutes before sun exposure.  Ensure skin is completely covered with product.
• reapply after 40 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours
• children under 6 months:  Ask a doctor
  

Other Information

• protect this product from excessive heat and direct sun
• for use on skin only
• avoid contact with fabric
  

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

OP DARK FORMULA XTREME TANNING 4 
octinoxate, octisalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62802-600
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3 mL  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
CARAMEL (UNII: T9D99G2B1R)
CANOLA OIL (UNII: 331KBJ17RK)
OLIVE OIL (UNII: 6UYK2W1W1E)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SUNFLOWER OIL (UNII: 3W1JG795YI)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLPARABEN (UNII: 14255EXE39)
GLYCERIN (UNII: PDC6A3C0OX)
HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
METHYLPARABEN (UNII: A2I8C7HI9T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYISOBUTYLENE (2300 MW) (UNII: DSQ2V1DD1K)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62802-600-08	251 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/01/2012

Labeler - Sun & Skin Care Research, LLC (849772207)

Establishment
Name	Address	ID/FEI	Business Operations
Sun & Skin Care Research, LLC		849772207	manufacture