CVS HEALTH AM MOISTURIZING FACIAL- homosalate, octinoxate, zinc oxide, octocrylene lotion

CVS Health by

Drug Labeling and Warnings

CVS Health by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Homosalate 12.0%, Octinoxate 7.5%, Zinc Oxide 3.5%, Octocrylene 2.0%

Purpose

Sunscreen

Uses

• helps prevent sunburn

Warnings

​ Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

For external use only

DO NOT USE

​Do not use

• ​​on damaged or broken skin

WHEN USING

​When using this product​ keep out of eyes. Rinse with water to remove.

STOP USE

​Stop use and ask doctor if​

• rash occurs.

KEEP OUT OF REACH OF CHILDREN

​Keep out of reach of children. ​If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally 15 minutes before sun exposure
• use a water resistant sunscreen if swimming or sweating
• reapply at least every 2 hours
• children under 6 months: ask a doctor

Other information

protect this product from excessive heat and direct sun

may stain or damage some fabrics, materials or surfaces

Inactive ingredients

Water (Purified), Niacinamide, Glycerin, Cetearyl Alcohol, Cetearyl Glucoside, Arachidyl Alcohol, Archidyl Glucoside, Aluminum Starch Octenylsuccinate, Boron Nitride, Dimethicone, Ceramide AP, Ceramide NP, Ceramide EOP, Cholesterol, Sodium Hyaluronate, Phytosphingosine, Lecithin, Phenoxyethanol, Behenyl Alcohol, Steareth-2, Steareth-21, Disodium EDTA, Sodium Lauroyl Lactylate, Triethoxycaprylylsilane, Methylparaben, Propylparaben, Carbomer, Xanthan Gum.

Questions or comments?

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PRINCIPAL DISPLAY PANEL

CVS Health

AM Moisturizing Facial Lotion

SPF 30 SUNSCREEN FOR NORMAL TO DRY SKIN

With ceramides, niacinamide & hyaluronic acid
Helps restore & maintain skin’s moisture barrier
Non-irritating, won’t clog pores
Sustained release formula

3 FL OZ (89 mL)

INGREDIENTS AND APPEARANCE

CVS HEALTH  AM MOISTURIZING FACIAL
homosalate, octinoxate, zinc oxide, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-139
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	20 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	35 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	120 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
BORON NITRIDE (UNII: 2U4T60A6YD)
CHOLESTEROL (UNII: 97C5T2UQ7J)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
WATER (UNII: 059QF0KO0R)
NIACINAMIDE (UNII: 25X51I8RD4)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARETH-2 (UNII: V56DFE46J5)
METHYLPARABEN (UNII: A2I8C7HI9T)
XANTHAN GUM (UNII: TTV12P4NEE)
CERAMIDE AP (UNII: F1X8L2B00J)
STEARETH-21 (UNII: 53J3F32P58)
DIMETHICONE (UNII: 92RU3N3Y1O)
DOCOSANOL (UNII: 9G1OE216XY)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CERAMIDE NP (UNII: 4370DF050B)
CERAMIDE 1 (UNII: 5THT33P7X7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-139-19	1 in 1 BOX	02/03/2017
1	NDC: 69842-139-18	89 mL in 1 BOTTLE; 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	02/03/2017

Labeler - CVS Pharmacy (062312574)

Registrant - Fruit of the Earth, Inc. (079559467)

Establishment
Name	Address	ID/FEI	Business Operations
Fruit Of The Earth Research Laboratories, Inc.		008193513	manufacture(69842-139)