EIGHT HOUR LIP SPF 15- petrolatum, padimate o, oxybenzone lipstick

EIGHT HOUR LIP SPF 15 by

Drug Labeling and Warnings

EIGHT HOUR LIP SPF 15 by is a Otc medication manufactured, distributed, or labeled by REVLON, Revlon. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Active Ingredients Purpose
PETROLATUM 30.2% ............. Skin Protectant
PADIMATE O 8.0%....................Sunscreen
OXYBENZONE 3.0%.................Sunscreen

Inactive Ingredients

RICINUS COMMUNIS (CASTOR) SEED OIL, OZOKERITE, GLYCERYL ROSINATE, CETYL LACTATE, LANOLIN OIL, MYRISTYL LACTATE, CETYL ACETATE, EUPHORBIA CERIFERA (CANDELILLA) WAX/CANDELILLA CERA/CIRE DE CANDELILLA, COPERNICIA CERIFERA (CARNAUBA) WAX/CERA CARNAUBA/CIRE DE CARNAUBA, MYRISTYL ALCOHOL, ACETYLATED LANOLIN ALCOHOL, BEESWAX/CERA ALBA/CIRE D'ABEILLE, CAPRYLYL GLYCOL, GLYCINE SOJA (SOYBEAN) OIL, METHYLSTYRENE/VINYLTOLUENE COPOLYMER, MICROCRYSTALLINE WAX/CERA MICROCRISTALLINA/CIRE MICROCRISTALLINE, PARFUM/FRAGRANCE, TOCOPHEROL, ZEA MAYS (CORN) OIL, BHT, CITRAL, CITRONELLOL, GERANIOL, LIMONENE, LINALOOL, PHENOXYETHANOL, IRON OXIDES (CI 77491, CI 77492, CI 77499), TITANIUM DIOXIDE (CI 77891).

Uses

Uses

• helps prevent sunburn
• Temporarily protects and helps relieve

- chapping

- peeling or flaking due to minor sunburn

- windburn

- cracked lips

Warnings

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 prevent sunburn, not skin cancer or early skin aging.

• For external use only
• Do not use on damaged or broken skin
• Stop use and ask a doctor if rash occurs or if condition lasts more than 7 days.
• Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions for Use

Directions

• Apply liberally as often as necessary

For Sunscreen Use:

• Apply liberally 15 minutes before sun exposure
• reapply:

- at least every 2 hours

• children under 6 months: Ask a doctor.

DOSAGE & ADMINISTRATION

As needed

INDICATIONS & USAGE

• Helps prevent sunburn
• Temporarily protects and helps relieve
• chapping
• peeling or flaking due to minor sunburn
• windburn
• cracked lips

PURPOSE

Sunscreen

Skin Protectant

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

carton art

INGREDIENTS AND APPEARANCE

EIGHT HOUR LIP SPF 15 
petrolatum, padimate o, oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10967-679
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	3 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	30.2 mg  in 1 g
PADIMATE O (UNII: Z11006CMUZ) (PADIMATE O - UNII:Z11006CMUZ)	PADIMATE O	8 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
FERRIC OXIDE RED (UNII: 1K09F3G675)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
TOCOPHEROL (UNII: R0ZB2556P8)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SOYBEAN OIL (UNII: 241ATL177A)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
CORN OIL (UNII: 8470G57WFM)
CITRAL (UNII: T7EU0O9VPP)
GERANIOL (UNII: L837108USY)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
CARNAUBA WAX (UNII: R12CBM0EIZ)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
LANOLIN OIL (UNII: OVV5IIJ58F)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CASTOR OIL (UNII: D5340Y2I9G)
CERESIN (UNII: Q1LS2UJO3A)
MYRISTYL LACTATE (UNII: 1D822OC34X)
CETYL ACETATE (UNII: 4Q43814HXS)
YELLOW WAX (UNII: 2ZA36H0S2V)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
GLYCERYL ROSINATE (UNII: SD112V492J)
CETYL LACTATE (UNII: A7EVH2RK4O)
MYRISTYL ALCOHOL (UNII: V42034O9PU)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CANDELILLA WAX (UNII: WL0328HX19)
ACETYLATED LANOLIN ALCOHOLS (UNII: SNN716810P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10967-679-61	3.7 g in 1 CARTRIDGE; Type 0: Not a Combination Product	10/21/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/21/2020

Labeler - REVLON (788820165)

Registrant - REVLON (788820165)

Establishment
Name	Address	ID/FEI	Business Operations
Revlon		809725570	manufacture(10967-679)