MOISTURE MELT- octinoxate, oxybenzone, and petrolatum gel

Moisture Melt by

Drug Labeling and Warnings

Moisture Melt by is a Otc medication manufactured, distributed, or labeled by Blistex Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Octinoxate 7.5% (w/w)	Sunscreen
Oxybenzone 2.5% (w/w)	Sunscreen
Petrolatum 31.7% (w/w)	Lip protectant

Uses

• temporarily protects and helps relieve chapped or cracked lips
• 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 help prevent sunburn, 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 reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally 15 minutes before sun exposure
• reapply at least every 2 hours
• use a water resistant sunscreen if swimming or sweating
• children under 6 months of age: Ask a doctor

Inactive ingredients

aloe barbadensis leaf extract, blue 1 lake, brassica campestris/aleurites fordi oil copolymer, butyrospermum parkii (shea butter), C10-30 cholesterol/lanosterol esters, cetyl dimethicone, cocos nucifera (coconut) oil, ethylhexyl palmitate, flavors, hydrogenated coconut oil, microcrystalline wax, mineral oil, persea gratissima (avocado) oil, phenoxyethanol, polybutene, polyethylene, saccharin, silica, squalane

Other information

• protect the product in this container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL - 10 g Tube Blister Pack

NDC: 10157-9955-1

Blistex®

LIP PROTECTANT/SUNSCREEN

Moisture
Melt™

Long-Lasting Hydration

Melting Beads Of
Shea Butter & Aloe

SPF 15

New!

NET WT.
.35 oz (10g)

INGREDIENTS AND APPEARANCE

MOISTURE MELT 
octinoxate, oxybenzone, and petrolatum gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10157-9955
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	7.5 g  in 100 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	2.5 g  in 100 g
Petrolatum (UNII: 4T6H12BN9U) (Petrolatum - UNII:4T6H12BN9U)	Petrolatum	31.7 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
aloe vera leaf (UNII: ZY81Z83H0X)
fd&c blue no. 1 (UNII: H3R47K3TBD)
aluminum oxide (UNII: LMI26O6933)
shea butter (UNII: K49155WL9Y)
C10-30 cholesterol/lanosterol esters (UNII: 137SL7IL0Y)
coconut oil (UNII: Q9L0O73W7L)
ethylhexyl palmitate (UNII: 2865993309)
hydrogenated coconut oil (UNII: JY81OXM1OM)
microcrystalline wax (UNII: XOF597Q3KY)
mineral oil (UNII: T5L8T28FGP)
avocado oil (UNII: 6VNO72PFC1)
phenoxyethanol (UNII: HIE492ZZ3T)
high density polyethylene (UNII: UG00KM4WR7)
saccharin (UNII: FST467XS7D)
silicon dioxide (UNII: ETJ7Z6XBU4)
squalane (UNII: GW89575KF9)

Product Characteristics
Color	WHITE (white with blue beads)	Score
Shape		Size
Flavor	BLUEBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10157-9955-1	1 in 1 BLISTER PACK	06/01/2012
1		10 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	06/01/2012

Labeler - Blistex Inc (005126354)

Establishment
Name	Address	ID/FEI	Business Operations
Blistex Inc		005126354	MANUFACTURE(10157-9955)