CeraVe Developed with Dermatologists Healing Lip Balm Broad Spectrum SPF 30 Sunscreen: Package Insert and Label Information

CERAVE DEVELOPED WITH DERMATOLOGISTS HEALING LIP BALM BROAD SPECTRUM SPF 30 SUNSCREEN- avobenzone, dimethicone, homosalate, octisalate and octocrylene stick
L’Oreal USA Products 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.

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

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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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE (AVOBENZONE) AVOBENZONE 30 mg in 1 g
DIMETHICONE (DIMETHICONE) DIMETHICONE 10 mg in 1 g
HOMOSALATE (HOMOSALATE) HOMOSALATE 100 mg in 1 g
OCTISALATE (OCTISALATE) OCTISALATE 50 mg in 1 g
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 100 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
PARAFFIN
ETHYLHEXYL PALMITATE
CERESIN
CANDELILLA WAX
PETROLATUM
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)
CETYL ALCOHOL
HIGH DENSITY POLYETHYLENE
CERAMIDE 1
CERAMIDE 3
CERAMIDE 6 II
CERAMIDE NG
CERAMIDE EOS
CHOLESTEROL
.ALPHA.-TOCOPHEROL ACETATE
GLYCERIN
BEHENIC ACID
ASCORBYL PALMITATE
WATER
HYALURONATE SODIUM
BUTYLATED HYDROXYTOLUENE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49967-201-01 1 CONTAINER in 1 CARTON contains a CONTAINER
1 4.25 g in 1 CONTAINER This package is contained within the CARTON (49967-201-01)
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 Operations
Accupac, Inc. 071609663 manufacture (49967-201)

Revised: 01/2020 L’Oreal USA Products Inc

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