CERAVE DEVELOPED WITH DERMATOLOGISTS HEAL AND PROTECT BALM- dimethicone stick

CeraVe Developed with Dermatologists Heal and Protect Balm by

Drug Labeling and Warnings

CeraVe Developed with Dermatologists Heal and Protect Balm by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Dimethicone 1%

Purpose

Skin protectant

Uses

• temporarily protects and helps relieve chafed, chapped or cracked skin
• helps protect from the drying effects of wind and cold weather

Warnings

For external use only

When using this product

do not get into eyes

Stop use and ask a doctor if

• condition worsens
• symptoms last more than 7 days or clear up and occur again within a few days

Do not use on

• deep or puncture wounds
• animal bites
• serious burns

Keep out of reach of children.

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

Directions

apply as needed

Inactive ingredients

paraffin, ethylhexyl palmitate, petrolatum, butyrospermum parkii (shea) butter, ozokerite, euphorbia cerifera (candelilla) wax, cetyl alcohol, glycerin, tocopheryl acetate, ceteareth-25, behenic acid, cholesterol, ceramide 1, ceramide 3, ceramide 6-II, ceramide EOS, ceramide NS, caprooyl phytosphingosine, caprooyl sphingosine, ascorbyl palmitate, water, BHT, sodium hyaluronate

Questions or comments?

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PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CERAVE DEVELOPED WITH DERMATOLOGISTS HEAL AND PROTECT BALM 
dimethicone stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-301
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PARAFFIN (UNII: I9O0E3H2ZE)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
PETROLATUM (UNII: 4T6H12BN9U)
SHEA BUTTER (UNII: K49155WL9Y)
CERESIN (UNII: Q1LS2UJO3A)
CANDELILLA WAX (UNII: WL0328HX19)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CETEARETH-25 (UNII: 8FA93U5T67)
BEHENIC ACID (UNII: H390488X0A)
CHOLESTEROL (UNII: 97C5T2UQ7J)
CERAMIDE 1 (UNII: 5THT33P7X7)
CERAMIDE 3 (UNII: 4370DF050B)
CERAMIDE 6 II (UNII: F1X8L2B00J)
CERAMIDE EOS (UNII: CR0J8RN66K)
CERAMIDE NG (UNII: C04977SRJ5)
N-HEXANOYLSPHINGOSINE (UNII: 038753E78J)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
WATER (UNII: 059QF0KO0R)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-301-01	42.5 g in 1 CONTAINER; Type 0: Not a Combination Product	10/01/2017	01/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	10/01/2017	01/01/2022

Labeler - L'Oreal USA Products Inc (002136794)