HOMOSALATE, OCTISALATE, ZINC OXIDE lotion

Homosalate, Octisalate, Zinc oxide by

Drug Labeling and Warnings

Homosalate, Octisalate, Zinc oxide by is a Otc medication manufactured, distributed, or labeled by Topco Associates LLC, Nice-Pak Products, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Claims

Top Care ® beauty

Morning Facial Moisturizing Lotion

Active ingredients

Homosalate 10%

Octisalate 5%

Zinc Oxide 6.3%

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

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

• apply liberally {and evenly} 15 minutes before sun exposure
• apply to all skin exposed to the sun
• 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, glycerin, cetearyl alcohol, niacinamide, behentrimonium methosulfate, dimethicone, ceramide NP, ceramide AP, ceramide EOP, carbomer, triethoxycaprylylsilane, chlorphenesin, sodium lauroyl lactylate, cholesterol, aluminum starch octenylsuccinate, disodium EDTA, sodium hydroxide, benzyl alcohol, hydroxyethylcellulose, sodium hyaluronate, phytosphingosine, xanthan gum

Questions or comments?

Call 1-888-423-0139

Disclaimers

May stain or damage some fabrics or surfaces.

*This product is not manufactured or distributed by L’Oreal USA S/D, Inc., distributor of CeraVe ® AM Facial Moisturizing Lotion with Sunscreen Broad Spectrum SPF 30.

Adverse Reactions

DISTRIBUTED BY TOPCO ASSOCIATES, LLC

ITASCA, IL 60143 ©TOPCO

QUESTIONS? 1-888-423-0139

topcare@topco.com

www.topcarebrand.com

Scan here for more information or call 1-888-423-0139

QUALITY GUARANTEED

Top Panel and Side Panel Claims

Top Care ® beauty

Compare to CeraVe ® AM Facial Moisturizing Lotion*

Morning Facial Moisturizing Lotion

Principal Display Panel

Compare to CeraVe ® AM Facial Moisturizing Lotion*

Top Care ® beauty

Morning Facial Moisturizing Lotion

Dermatologist Tested

Contains Ceramides, Niacinamide & Hyaluronic Acid

BROAD SPECTRUM 30 SPF

3 FL OZ (89 mL)

INGREDIENTS AND APPEARANCE

HOMOSALATE, OCTISALATE, ZINC OXIDE 
homosalate, octisalate, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76162-957
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	63 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CERAMIDE 1 (UNII: 5THT33P7X7)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
CHLORPHENESIN (UNII: I670DAL4SZ)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
CHOLESTEROL (UNII: 97C5T2UQ7J)
CERAMIDE AP (UNII: F1X8L2B00J)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DIMETHICONE, UNSPECIFIED (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)
CERAMIDE NP (UNII: 4370DF050B)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
NIACINAMIDE (UNII: 25X51I8RD4)
BENZYL ALCOHOL (UNII: LKG8494WBH)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76162-957-21	1 in 1 CARTON	01/22/2026
1		89 mL in 1 BOTTLE, PLASTIC; 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	01/22/2026

Labeler - Topco Associates LLC (006935977)

Registrant - Nice-Pak Products, LLC (119091520)

Establishment
Name	Address	ID/FEI	Business Operations
Nice-Pak Products, LLC		119091514	manufacture(76162-957)