EIGHT HOUR CREAM LIP PROTECTANT SHEER TINT SPF 15 MELON- petrolatum stick

United States - English - NLM (National Library of Medicine)

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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 1.117 g in 3.7 g
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
To Use: Apply liberally as often as necessary. SPF 15 protects against UV exposure.
Authorization status:
OTC monograph final
Authorization number:
67938-1470-1, 67938-1470-2

EIGHT HOUR CREAM LIP PROTECTANT SHEER TINT SPF 15 MELON- 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.

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BL1470

DESCRIPTION

Moisturizes, softens and smooths lips. Provides antioxidant protection with vitamin E. SPF 15 protects

against UV exposure. Provides a sheer wash of color in 6 translucent shades. Dermatologist, clinically

and allergy tested.

INDICATIONS AND USAGE

To Use: Apply liberally as often as necessary.

WARNINGS

Warning: If condition worsens or does not improve within 7 days, consult a physician.

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: Ozokerite, Ricinus Communis (Castor) Seed Oil, Glyceryl Rosinate, Cetyl Lactate,

Lanolin Oil, Myristyl Lactate, Cetyl Acetate, Euphorbia Cerifera (Candelilla) Wax/Candelilla Cera/Cire

De Candelilla, Copernicia Cerifera (Carnauba) Wax/Cer 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/Huile Vegetale, Zea Mays (Corn) Oil, Citral Citronellol, Geraniol, Limonene, Linalool,

Butylparaben, Propylparaben.

May Contain: Blue 1 Lake (CI 42090), Iron Oxides (CI 77491, CI 77499, CI 77492), Red 6 Lake (CI

15850), Red 7 Lake (CI 15850), Red 21 Lake (CI 45380), Red 27 Lake (CI 45410), Titanium Dioxide

(CI 77891), Yellow 5 Lake (CI 19140), Yellow 6 Lake (CI15985).

DOSAGE & ADMINISTRATION

Apply to lips.

OTC - KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OTC - PURPOSE

SPF 15 protects against UV exposure.

OTC - WHEN USING

Note condition.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EIGHT HOUR CREAM LIP PROTECTANT SHEER TINT SPF 15 MELON

petrolatum stick

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 79 38 -1470

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

1.117 g in 3.7 g

PADIMATE O (UNII: Z110 0 6 CMUZ) (PADIMATE O - UNII:Z110 0 6 CMUZ)

PADIMATE O

0 .29 6 g in 3.7 g

O XYBENZO NE (UNII: 9 5OOS7VE0 Y) (OXYBENZONE - UNII:9 5OOS7VE0 Y)

OXYBENZONE

0 .111 g in 3.7 g

Elizabeth Arden, Inc

Inactive Ingredients

Ingredient Name

Stre ng th

CASTO R O IL (UNII: D5340 Y2I9 G)

MYRISTYL LACTATE (UNII: 1D8 22OC34X)

CANDELILLA WAX (UNII: WL0 328 HX19 )

YELLO W WAX (UNII: 2ZA36 H0 S2V)

MICRO CRYSTALLINE WAX (UNII: XOF59 7Q3KY)

BUTYLPARABEN (UNII: 3QPI1U3FV8 )

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

BUTYLATED HYDRO XYTO LUENE (UNII: 1P9 D0 Z171K)

ALPHA-TO CO PHERO L (UNII: H4N8 55PNZ1)

CO RN O IL (UNII: 8 470 G57WFM)

Product Characteristics

Color

ORANGE (Melo n)

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 79 38 -1470 -1

1 in 1 BOX

1

NDC:6 79 38 -1470 -2

3.7 g in 1 TUBE

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt352

0 3/28 /20 0 6

Labeler -

Elizabeth Arden, Inc (849222187)

Revised: 1/2011

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