OCEAN POTION MOISTURIZING LIP POTION 45 - avobenzone, octisalate, octocrylene, oxybenzone, octinoxate lipstick
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.

----------

Drug Facts

Active Ingredients

Avobenzone: 2%
Octinoxate: 7%
Octisalate: 5%
Octocrylene: 5%
Oxybenzone: 5%

Purpose

Sunscreen

Uses

helps prevent sunburn
higher SPF gives more sunburn protection
temporarily protects lips from the drying effects of wind and cold weather

Warnings

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 contact a Poison Control Center right away.

Directions

apply liberally before sun exposure and as needed
children under 6 months of age: ask a doctor
store at room temperature

Other Information

For use on skin only
Avoid contact with fabric
Protect this product from excessive heat and direct sun

OCEAN POTION MOISTURIZING LIP POTION 45
avobenzone, octisalate, octocrylene, oxybenzone, octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62802-085
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	5.0 g in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5.0 g in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
YELLOW WAX (UNII: 2ZA36H0S2V)
COCONUT OIL (UNII: Q9L0O73W7L)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
CORN OIL (UNII: 8470G57WFM)
MINERAL OIL (UNII: T5L8T28FGP)
MYRISTYL LACTATE (UNII: 1D822OC34X)
CERESIN (UNII: Q1LS2UJO3A)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SACCHARIN (UNII: FST467XS7D)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62802-085-01	4.4 g in 1 CONTAINER

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