EIGHT HOUR CREAM LIP PROTECTANT SPF 15- petrolatum stick

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U), PADIMATE O (UNII: Z11006CMUZ) (PADIMATE O - UNII:Z11006CMUZ), OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)

Available from:

Elizabeth Arden, Inc

INN (International Name):

PETROLATUM

Composition:

PETROLATUM 1.12 g in 3.7 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Apply to lips. Protects skin. Provides SPF 15 sun protection.

Authorization status:

OTC monograph final

Summary of Product characteristics

EIGHT HOUR CREAM LIP PROTECTANT SPF 15- PETROLATUM STICK
ELIZABETH ARDEN, 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._
----------
BL0774
DESCRIPTION
An all weather treatment stick for softer, smoother lips. Sunscreen
ingredients (SPF 15) guard against
the damaging effects of sun exposure. Dermatologist, clinically and
allergy tested.
INDICATIONS AND USAGE
Apply to lips.
WARNINGS
Warnings: Discontinue use if signs of irritation or rash appear and
see a doctor. Keep out of reach of
children.
OTC - ACTIVE INGREDIENT
Active Ingredients: Petrolatum 30.2% w/w, Padimate O 8.0% w/w,
Oxybenzone 3.0% w/w.
INACTIVE INGREDIENT
Other Ingredients: Ricinus Communis (Castor) Seed Oil, Ozokerite,
Glyceryl Rosinate, Cetyl Lactate,
Myristyl Lactate, Lanolin Oil, Cetyl Acetate, Euphorbia Cerifera
(Candelilla) Wax/Candelilla Cera/Cire
de Candelilla, Copernicia Cerifera (Carnauba) Wax/Cera Carnauba/Cire
De Carnauba, Beeswax/Cera
Alba/Cire D'Abeille, Tocopherol, Acetylated Lanolin Alcohol,
Methylstyrene/Vinyltoluene
Copolymer, Microcrystalline Wax/Cera Microcristallina/Cire
Microcristalline, BHT, Vegetable
Oil/Olus/Huille Vegetale, Zea Mays (Corn) Oil, Parfum/Fragrance,
Citral, Citronellol, Geraniol,
Limonene, Linalool, Butylparaben, Propylparaben, Iron Oxides.
DOSAGE & ADMINISTRATION
Apply to lips.
OTC - KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children.
OTC - PURPOSE
Protects skin. Provides SPF 15 sun protection.
OTC - WHEN USING
Discontinue use if signs of irritation or rash appear.
EIGHT HOUR CREAM LIP PROTECTANT SPF 15
petrolatum stick
PRODUCT INFORMATION
Elizabeth Arden, Inc
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 79 38 -0 774
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
PETRO LATUM (UNII: 4T6 H12BN9 U) (PETROLATUM - UNII:4T6 H12BN9 U)
PETROLATUM
1.12 g in 3.7 g
PADIMATE O (UNI