Dove DermaSeries Dry Skin Relief Replenishing Face Cream SPF 15

Drug Labeling and Warnings

Drug Details [pdf]

DOVE DERMASERIES DRY SKIN RELIEF REPLENISHING FACE CREAM SPF 15- avobenzone,ensulizole, octisalate, octocrylene cream 
Les Emballages Knowlton 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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Dove DermaSeries Dry Skin Relief Replenishing Face Cream SPF 15

Drug Facts

Active ingredients

Avobenzone 2.0%

Ensulizole 1.5%

Octisalate 5.0%

Octocrylene 1.3%

Purpose

Sunscreen

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

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

• Massage gently into face and neck for instant relief and lasting hydration
• Apply liberally to face and neck 15 minutes before sun exposure
• Children under 6 months of age: Ask a doctor
• 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 10 a.m.-2 p.m.
• Wear long-sleeved shirts, pants, hats and sunglasses
• Reapply at least every 2 hours
• Use a water resistant sunscreen if swimming or sweating

Other information

• Protect the product in this container from excessive heat and direct sun

Inactive ingredients

Water (Aqua), Glycerin, Stearic Acid, Glycol Stearate, PEG-100 Stearate, Dimethicone, Glyceryl Stearate, Phenoxyethanol, Carbomer, Caprylyl Glycol, Cetyl Alcohol, Xanthan Gum, Disodium EDTA, BHT, Stearamide AMP, Silk Amino Acids, Ascorbic Acid, Panthenol, Tocopheryl Acetate, Biotin, Niacinamide.

Questions or Comments?

1-800-761-3683

For severely dry, itchy skin tested with dermatologists, fragrance free  non-comedogenic broad spectrum SPF 15 sunscreen

Packaging

DOVE  DERMASERIES DRY SKIN RELIEF REPLENISHING FACE CREAM SPF 15
avobenzone,ensulizole, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54565-1908
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 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 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)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETYL ALCOHOL (UNII: 936JST6JCN)
XANTHAN GUM (UNII: TTV12P4NEE)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
STEARAMIDE AMP (UNII: U3K8640346)
AMINO ACIDS, SILK (UNII: V0L00EX1IA)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
PANTHENOL (UNII: WV9CM0O67Z)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
BIOTIN (UNII: 6SO6U10H04)
NIACINAMIDE (UNII: 25X51I8RD4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54565-1908-1	50 mL in 1 TUBE; Type 0: Not a Combination Product	07/12/2017
2	NDC: 54565-1908-2	141 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/12/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/12/2017

Labeler - Les Emballages Knowlton Inc. (248704645)

Establishment
Name	Address	ID/FEI	Business Operations
Les Emballages Knowlton Inc.		248704645	manufacture(54565-1908)

Revised: 11/2017

Document Id: 5d8e5726-5402-898c-e053-2991aa0aca76

34390-5

Set id: 5d8e59d4-dbef-f680-e053-2991aa0a9060

Version: 1

Effective Time: 20171109