CERAVE DEVELOPED WITH DERMATOLOGISTS HEALING LIP BALM- petrolatum cream

Drug Labeling and Warnings

Drug Details [pdf]

Active ingredient

Petrolatum 49.5%

Purpose

Lip protectant

Uses

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

Warnings

For external use only

Do not use on

• deep or puncture wounds
• animal bites
• serious burns

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

Keep out of reach of children.

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

Directions

apply as needed

Inactive ingredients

mineral oil, microcrystalline wax, glycerin, paraffin, synthetic wax, ceramide NP, ceramide AP, ceramide EOP, carbomer, water, triethyl citrate, sodium lauroyl lactylate, sodium hyaluronate, cholesterol, tocopheryl acetate, tocopherol, caprylyl glycol, panthenol, phytosphingosine, xanthan gum, benzoic acid

Questions or comments?

Toll-Free Number 1-888-768-2915

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CERAVE DEVELOPED WITH DERMATOLOGISTS HEALING LIP BALM 
petrolatum cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82046-483
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	495 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
GLYCERIN (UNII: PDC6A3C0OX)
PARAFFIN (UNII: I9O0E3H2ZE)
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)
CERAMIDE NP (UNII: 4370DF050B)
CERAMIDE AP (UNII: F1X8L2B00J)
CARBOMER (UNII: 0A5MM307FC)
WATER (UNII: 059QF0KO0R)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
CHOLESTEROL (UNII: 97C5T2UQ7J)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TOCOPHEROL (UNII: R0ZB2556P8)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PANTHENOL (UNII: WV9CM0O67Z)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
XANTHAN GUM (UNII: TTV12P4NEE)
BENZOIC ACID (UNII: 8SKN0B0MIM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82046-483-01	1 in 1 CARTON	05/20/2026
1		9 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 82046-483-02	2 in 1 CARTON	05/20/2026
2		9 g 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 Drug	M016	05/20/2026

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
Beauty Manufacturing Solutions Corp.		783200723	manufacture(82046-483)