OP SPF45 LIP POTION CLEAR ZINC- avobenzone, octyl salicylate, octocrylene, oxybenzone, octinoxate stick

OP spf45 Lip Potion Clear Zinc by

Drug Labeling and Warnings

OP spf45 Lip Potion Clear Zinc by is a Otc medication manufactured, distributed, or labeled by SolSkyn Personal Care LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

OP spf45 1oz Lip Potion Clear Zinc

Active Ingredients

Avobenzone 2.0%

Active Ingredients

Octyl Salicylate 5.0%

Active Ingredients

Octocrylene 5.0%

Active Ingredients

Oxybenzone 5.0%

Active Ingredients

Octinoxate 7.0%

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

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 reach of children.

If accidentally swallowed, contact a Poison Control Center right away.

Directions:

Apply liberally before sun exposure as needed.

Children under 6 months of age: ask a doctor.

Store at room temperature.

Inactive Ingredients: 

Aloe Vera Leaf Extract, Beeswas, Cocos Nucifera (Coconut Oil), Copernica Cerifera (Carnuba Wax), Euphoria Cerifera (Candelilla Wax), Flavor, Hydrogenated Vegetable Oil, Mineral Oil, Myristyl Lactate, Ozokerite, Petrolatum, Propylparaben, Saccharin, PVP/Hexadecene Copolymer

Other information:

For use on skin only. Avoid contact with fabric.

Protect this product from excessive heat and direct sun.

Questions or comments?

Call toll free 1-800-715-3485

PRINCIPAL DISPLAY PANEL

Moisturizing
Lip Potion
with Aloe Vera
NET WT .15 oz

INGREDIENTS AND APPEARANCE

OP SPF45 LIP POTION CLEAR ZINC 
avobenzone, octyl salicylate, octocrylene, oxybenzone, octinoxate stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70281-202
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM, OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y, OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	5 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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)
COPOVIDONE (UNII: D9C330MD8B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70281-202-03	4.25 g in 1 CONTAINER; Type 0: Not a Combination Product	09/15/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/15/2015

Labeler - SolSkyn Personal Care LLC (080010329)