DOVE MEN PLUS CARE HYDRATE FACE- avobenzone, ensulizole, octisalate, octocrylene lotion

Dove by

Drug Labeling and Warnings

Dove by is a Otc medication manufactured, distributed, or labeled by CONOPCO Inc. d/b/a Unilever. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients
Avobenzone (2.0%)
Ensulizole (1.5%)
Octisalate (5.0%)

Octocrylene (1.3%)

PURPOSE

Purpose
Sunscreen

INDICATIONS & USAGE

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 swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions· apply liberally to face and neck 15 minutes before sun exposure
· reapply at least every 2 hours
· use a water resistant sunscreen if swimming or sweating
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 value of 15 or higher and other sun protection measures including:
· limit time in the sun, especially from 10a.m. - 2p.m.
· wear long-sleeved shirts, pants, hats, and sunglasses

· children under 6 months of age; ask a doctor

INACTIVE INGREDIENT

Inactive ingredients

Water (Aqua), Glycerin, Stearic Acid, Glycol Stearate, PEG-100 Stearate, Dimethicone, Tocopheryl Acetate, Glyceryl Stearate, Potassium Stearate, Carbomer, Caprylyl Glycol, Cetyl Alcohol, Xanthan Gum, Fragrance (Parfum), Stearamide AMP, BHT, Phenoxyethanol, Disodium EDTA

QUESTIONS

Questions or comments?
Call toll free 1-800-761-DOVE (3683)

PDP 1.69 fl oz

Carton 1.69 fl oz

INGREDIENTS AND APPEARANCE

DOVE  MEN PLUS CARE HYDRATE FACE
avobenzone, ensulizole, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64942-1334
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	Avobenzone	2.0 g  in 100 mL
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	1.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5.0 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1.3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
STEARIC ACID (UNII: 4ELV7Z65AP)
GLYCOL STEARATE (UNII: 0324G66D0E)
PEG-100 STEARATE (UNII: YD01N1999R)
DIMETHICONE (UNII: 92RU3N3Y1O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POTASSIUM STEARATE (UNII: 17V812XK50)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETYL ALCOHOL (UNII: 936JST6JCN)
XANTHAN GUM (UNII: TTV12P4NEE)
STEARAMIDE AMP (UNII: U3K8640346)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64942-1334-2	1 in 1 CARTON
1	NDC: 64942-1334-1	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2	NDC: 64942-1334-3	15 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/22/2016

Labeler - CONOPCO Inc. d/b/a Unilever (001375088)

Establishment
Name	Address	ID/FEI	Business Operations
Unilever Manufacturing (US), Inc.		021679448	manufacture(64942-1334)