CERAVE HYDRATING MINERAL SUNSCREEN LIGHT SHEER TINT BROAD SPECTRUM SPF 30- titanium dioxide and zinc oxide lotion

CERAVE Hydrating Mineral Sunscreen Light Sheer Tint Broad Spectrum SPF 30 by

Drug Labeling and Warnings

CERAVE Hydrating Mineral Sunscreen Light Sheer Tint Broad Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by L’Oreal USA Products Inc, L'OREAL USA PRODUCTS, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Titanium dioxide 5.5%

Zinc oxide 10%

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 boken 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

water, C12-15 alkyl benzoate, isohexadecane, isononyl isononanoate, dicaprylyl ether, PEG-30 dipolyhydroxystearate, polyglyceryl-3 diisostearate, ceramide NP, ceramide AP, ceramide EOP, carbomer, acrylates/C10-30 alkyl acrylate crosspolymer, triethanolamine, alkyl sodium chloride, glycine soja (soybean) oil, cetearyl alcohol, triethylhexanoin, behentrimonium methosulfate, lauryl laurate, cholesterol, aluminum stearate, chlorphenesin, tocopherol, disodium EDTA, iron oxides, p-anisic acid, alumina, aluminum hydroxide, phenoxyethanol, salicylic acid, capryloyl salicylic acid, trisodium ethylenediamine disuccinate, propylene carbonate, citric acid, castoryl dimethyl caprate, distearyldimonium chloride, glyceryl trilinoleate, disteardimonium hectorite, xanthan gum, phytosphingosine, polyhydroxystearic acid, benzoic acid

Questions or comments?

Toll-free number: 1-888-768-2915

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CERAVE HYDRATING MINERAL SUNSCREEN LIGHT SHEER TINT BROAD SPECTRUM SPF 30 
titanium dioxide and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-589
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (CI 77891 - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	55 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
ISOHEXADECANE (UNII: 918X1OUF1E)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
DICAPRYLYL ETHER (UNII: 77JZM5516Z)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
BEHENYL ACRYLATE POLYMER (UNII: D64PM5UT4U)
STEARIC ACID (UNII: 4ELV7Z65AP)
CERAMIDE NP (UNII: 4370DF050B)
CERAMIDE AP (UNII: F1X8L2B00J)
CARBOMER (UNII: 0A5MM307FC)
NIACINAMIDE (UNII: 25X51I8RD4)
SOYBEAN OIL (UNII: 241ATL177A)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
CHOLESTEROL (UNII: 97C5T2UQ7J)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
ALUMINA (UNII: LMI26O6933)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
P-ANISIC ACID (UNII: 4SB6Y7DMM3)
CHLORPHENESIN (UNII: I670DAL4SZ)
TOCOPHEROL (UNII: R0ZB2556P8)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
CITRIC ACID (UNII: 2968PHW8QP)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CAPRYLOYL SALICYLIC ACID (UNII: 5F7PJF6AA4)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
XANTHAN GUM (UNII: TTV12P4NEE)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
BENZOIC ACID (UNII: 8SKN0B0MIM)
CI 77492 (UNII: EX438O2MRT)
CI 77491 (UNII: 1K09F3G675)
CI 77499 (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-589-01	1 in 1 CARTON	08/15/2024
1		50 mL 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	M020	08/15/2024

Labeler - L’Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'OREAL USA PRODUCTS, INC.		624244349	manufacture(49967-589)