CERAVE DEVELOPED WITH DERMATOLOGISTS SUNSCREEN BROAD SPECTRUM SPF 50- titanium dioxide, zinc oxide stick

CeraVe Developed with Dermatologists Sunscreen Broad Spectrum SPF 50 by

Drug Labeling and Warnings

CeraVe Developed with Dermatologists Sunscreen Broad Spectrum SPF 50 by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, Autumn Harp, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Titanium dioxide 6%

Zinc oxide 4.7%

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

Stop use and ask a doctor if

rash occurs

When using this product

keep out of eyes. Rinse with water to remove.

Keep out of reach of children.

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

Directions

• Apply liberally 15 minutes before sun exposure.
• Reapply:
  • After 40 minutes of swimming or sweating
  • Immediately after towel drying
  • At least every 2 hours
• Children under 6 months: 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.

Inactive Ingredients

C12-15 Alkyl Benzoate, Butyloctyl Salicylate, Neopentyl Glycol Diethylhexanoate, Paraffin, Euphobia Cerifera (Candelilla) Wax, Ozokerite, Dimethicone, Beeswax, Polyethylene, Cetyl Alcohol, Ceramide 3, Ceramide 6-II, Ceramide 1, Cholesterol, Phytosphingosine, Sodium Hyaluronate, Polyhydrostearic Acid, Aluminum Hydroxide, Stearic Acid, BHT, Carbomer, Triethoxycaprylylsilane, Isostearic Acid, Sodium Lauroyl Lactylate, Xanthan Gum

Other information

Protect this product from excessive heat and direct sun

Questions?

Toll-free number 1-888-768-2915
www.cerave.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CERAVE DEVELOPED WITH DERMATOLOGISTS SUNSCREEN BROAD SPECTRUM SPF 50 
titanium dioxide, zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-014
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.80 g  in 13.32 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.63 g  in 13.32 g

Inactive Ingredients
Ingredient Name	Strength
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)
PARAFFIN (UNII: I9O0E3H2ZE)
CANDELILLA WAX (UNII: WL0328HX19)
CERESIN (UNII: Q1LS2UJO3A)
DIMETHICONE (UNII: 92RU3N3Y1O)
YELLOW WAX (UNII: 2ZA36H0S2V)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CETYL ALCOHOL (UNII: 936JST6JCN)
CERAMIDE NP (UNII: 4370DF050B)
CERAMIDE AP (UNII: F1X8L2B00J)
CERAMIDE 1 (UNII: 5THT33P7X7)
CHOLESTEROL (UNII: 97C5T2UQ7J)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ISOSTEARIC ACID (UNII: X33R8U0062)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-014-01	13.32 g in 1 BLISTER PACK; Type 0: Not a Combination Product	11/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	11/01/2017

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
Autumn Harp, Inc.		064187883	MANUFACTURE(49967-014)