BLISTEX HERBAL ANSWER- octinoxate, oxybenzone, and petrolatum stick

Blistex by

Drug Labeling and Warnings

Blistex 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 43% (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, beeswax, butyrospermum parkii (shea butter), cetyl alcohol, chamomilla recutita (matricaria) flower extract, flavor, helianthus annuus (sunflower) seed oil, isopropyl lanolate, lanolin, methylparaben, microcrystalline wax, ozokerite, paraffin, persea gratissima (avocado) oil, phenyl trimethicone, propylparaben, simmondsia chinensis (jojoba) seed oil

Other information

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

PRINCIPAL DISPLAY PANEL - 4.25g Cylinder Carton

NDC: 10157-9868-1

Blistex®
LIP PROTECTANT/SUNSCREEN

HERBAL
ANSWER®

Aloe, Avocado, Chamomile,
Shea Butter, Jojoba

NET WT. .15 oz (4.25g)

SPF 15

INGREDIENTS AND APPEARANCE

BLISTEX   HERBAL ANSWER
octinoxate, oxybenzone, and petrolatum stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10157-9868
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	43 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
yellow wax (UNII: 2ZA36H0S2V)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
METHYLPARABEN (UNII: A2I8C7HI9T)
LANOLIN (UNII: 7EV65EAW6H)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
microcrystalline wax (UNII: XOF597Q3KY)
CETYL ALCOHOL (UNII: 936JST6JCN)
JOJOBA OIL (UNII: 724GKU717M)
SHEA BUTTER (UNII: K49155WL9Y)
AVOCADO OIL (UNII: 6VNO72PFC1)
PARAFFIN (UNII: I9O0E3H2ZE)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CHAMOMILE (UNII: FGL3685T2X)
ceresin (UNII: Q1LS2UJO3A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10157-9868-1	1 in 1 CARTON	06/01/1999
1		4.25 g in 1 CYLINDER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	06/01/1999

Labeler - Blistex Inc. (005126354)

Establishment
Name	Address	ID/FEI	Business Operations
Blistex Inc.		005126354	MANUFACTURE(10157-9868)