BLISTEX HERBAL ANSWER- octinoxate, oxybenzone, and petrolatum stick

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51), Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y), petrolatum (UNII: 4T6H12BN9U) (petrolatum - UNII:4T6H12BN9U)

Available from:

Blistex Inc.

INN (International Name):

Octinoxate

Composition:

Octinoxate 7.5 g in 100 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

- temporarily protects and helps relieve chapped or cracked lips - helps prevent sunburn

Authorization status:

OTC monograph final

Summary of Product characteristics

BLISTEX HERBAL ANSWER- OCTINOXATE, OXYBENZONE, AND PETROLATUM STICK
BLISTEX INC.
_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._
----------
BLISTEX
HERBAL ANSWER
_DRUG FACTS_
_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
OTHER INFORMATION
protect the product in this container from excessive heat and direct
sun
®
®
INACTIVE INGREDIENTS
aloe barbadensis leaf extract (decolorized), beeswax, butyrospermum
parkii (shea)
butter, cetyl alcohol, chamomilla recutita (matricaria) flower
extract, flavors, 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
PRINCIPAL DISPLAY PANEL - 4.25 G CYLINDER CARTON
The Soothing
Herbal
Alternative
Blistex
®
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