EIGHT HOUR NOURISHING LIP SPF 20- octinoxate, avobenzone emulsion

EIGHT HOUR NOURISHING LIP SPF 20 by

Drug Labeling and Warnings

EIGHT HOUR NOURISHING LIP SPF 20 by is a Otc medication manufactured, distributed, or labeled by REVLON, Englewood Lab. INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Active Ingredients Purpose
OCTINOXATE 4.0%...................................................Sunscreen
AV0BENZONE 3.0%..................................................Sunscreen

Inactive Ingredients

POLYBUTENE, MICROCRYSTALLINE WAX/CERA MICROCRISTALLINA/CIRE MICROCRISTALLINE, PETROLATUM, RICINUS COMMUNIS (CASTOR) SEED OIL, BUTYROSPERMUM PARKII (SHEA) BUTTER, NYLON-12, DIOCTYLDODECYL DODECANEDIOATE, C12-15 ALKYL BENZOATE, GLYCERETH-26, BUTYLOCTYL SALICYLATE, LANOLIN, ASTROCARYUM MURUMURU SEED BUTTER, BEESWAX/CERA ALBA/CIRE D'ABEILLE, COPERNICIA CERIFERA (CARNAUBA) WAX/CERA CARNAUBA/CIRE DE CARNAUBA, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, HONEY EXTRACT, HYDROGENATED CASTOR OIL, LINOLEIC ACID, LINOLENIC ACI, NASTURTIUM OFFICINALE FLOWER/LEAF EXTRACT, RETINYL PALMITATE, TO DCOPHEROL, TOCOPHERYL ACETATE, BHT, IRON OXIDES (CI 77491, CI 77492).

Uses

Uses
- Helps prevent sunburn

- If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

Warnings
- 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 product is swallowed, get medical help or contact a Poison Control Center right away.

Directions For Sunscreen Use

Directions For Sunscreen Use:
- Apply liberally 15 minutes before sun exposure
- Reapply:

- at least every 2 hours
- Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
- Limit time in the sun, especially from 10 a.m. – 2 p.m.
- Wear long-sleeve shirts, pants, hats, and sunglasses

- Children under 6 months: Ask a doctor.

CARTON ART

INGREDIENTS AND APPEARANCE

EIGHT HOUR NOURISHING LIP SPF 20 
octinoxate, avobenzone emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10967-671
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	4 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
CASTOR OIL (UNII: D5340Y2I9G)
NYLON-12 (UNII: 446U8J075B)
SUNFLOWER OIL (UNII: 3W1JG795YI)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
LANOLIN (UNII: 7EV65EAW6H)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
SHEA BUTTER (UNII: K49155WL9Y)
GLYCERETH-26 (UNII: NNE56F2N14)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
YELLOW WAX (UNII: 2ZA36H0S2V)
HONEY (UNII: Y9H1V576FH)
LINOLENIC ACID (UNII: 0RBV727H71)
TOCOPHEROL (UNII: R0ZB2556P8)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
PETROLATUM (UNII: 4T6H12BN9U)
DIOCTYLDODECYL DODECANEDIOATE (UNII: 7QDB5EE79Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10967-671-61	14.2 g in 1 TUBE, WITH APPLICATOR; 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 final	part352	10/21/2020

Labeler - REVLON (788820165)

Registrant - REVLON (788820165)

Establishment
Name	Address	ID/FEI	Business Operations
Englewood Lab. INC.		080987545	manufacture(10967-671)