OP PROTECTIVE XTREME TANNING 8 - octinoxate, octisalate lotion
Sun & Skin Care Research, 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 4.5%
Octisalate 5.0%

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

image of carton label

OP PROTECTIVE XTREME TANNING 8
octinoxate, octisalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62802-690
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	4.5 mL in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62802-690-08	237 mL in 1 BOTTLE

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

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

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