CERAVE DEVELOPED WITH DERMATOLOGISTS HEALING LIP BALM BROAD SPECTRUM SPF 30 SUNSCREEN- avobenzone, dimethicone, homosalate, octisalate and octocrylene stick

CeraVe Developed with Dermatologists Healing Lip Balm Broad Spectrum SPF 30 Sunscreen by

Drug Labeling and Warnings

CeraVe Developed with Dermatologists Healing Lip Balm Broad Spectrum SPF 30 Sunscreen by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, Accupac, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredientS

Avobenzone 3%

Dimethicone 1%

Homosalate 10%

Octisalate 5%

Octocrylene 10%

Purpose

Sunscreen and Skin protectant

Uses

• temporarily protects and helps relieve chafed, chapped or cracked skin
• helps protect from the drying effects of wind and cold weather
• 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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:
● apply liberally 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 10 a.m. – 2 p.m.
● wear long-sleeved shirts, pants, hats, and sunglasses
● children under 6 months of age: Ask a doctor

Other information

protect the product in this container from excessive heat and direct sun

Inactive ingredients

paraffin, ethylhexyl palmitate, ozokerite, euphorbia cerifera (candelilla) wax, petrolatum, polyester-8, cetyl alcohol, polyethylene, ceramide 1, ceramide 3, ceramide 6-II, ceramide NS, ceramide EOS, cholesterol, tocopheryl acetate, glycerin, behenic acid, caprooyl phytosphingosine, caprooyl sphingosine, ascorbyl palmitate, stevia rebaudiana extract, water, sodium hyaluronate, BHT

Questions or comments?

Toll-free number 1-888-768-2915

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CERAVE DEVELOPED WITH DERMATOLOGISTS HEALING LIP BALM BROAD SPECTRUM SPF 30 SUNSCREEN 
avobenzone, dimethicone, homosalate, octisalate and octocrylene stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	10 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PARAFFIN (UNII: I9O0E3H2ZE)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CERESIN (UNII: Q1LS2UJO3A)
CANDELILLA WAX (UNII: WL0328HX19)
PETROLATUM (UNII: 4T6H12BN9U)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
CETYL ALCOHOL (UNII: 936JST6JCN)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CERAMIDE 1 (UNII: 5THT33P7X7)
CERAMIDE 3 (UNII: 4370DF050B)
CERAMIDE 6 II (UNII: F1X8L2B00J)
CERAMIDE NG (UNII: C04977SRJ5)
CERAMIDE EOS (UNII: CR0J8RN66K)
CHOLESTEROL (UNII: 97C5T2UQ7J)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERIN (UNII: PDC6A3C0OX)
BEHENIC ACID (UNII: H390488X0A)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
WATER (UNII: 059QF0KO0R)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-201-01	1 in 1 CARTON	08/31/2017
1		4.25 g in 1 CONTAINER; 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	08/31/2017

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
Accupac, Inc.		071609663	manufacture(49967-201)