CVS HEALTH SPF 30 ULTRA SHEER- avobenzone, homosalate, octinoxate, octisalate, oxybenzone 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

Avobenzone 2.0%, Homosalate 7.0%, Octinoxate 7.5%, Octisalate 5.0%, Oxybenzone 3.0%

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

​Do not use ​​on damaged or broken skin

WHEN USING

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

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.

STOP USE

​Stop use and ask a doctor if rash occurs.​

Directions

apply liberally 15 minutes before sun exposure

reapply:

after 80 minutes of swimming or sweating

immediately after towel drying

at least every 2 hours

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 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-sleeve shirts, pants, hats, and sunglasses

children under 6 months: ask a doctor

Inactive ingredients

water, silica, adipic acid/diethylene glycol/glycerin crosspolymer, VP/hexadecene copolymer, dimethicone, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, glycerin, avena sativa (oat) kernel extract, squalane, ascorbyl palmitate, retinyl palmitate, tocopheryl acetate, BHT, cetyl dimethicone, bisabolol, dipotassium glycyrrhizate, glyceryl stearate, PEG-100 stearate, polysorbate 60, tetrasodium EDTA, butylene glycol, trimethylsiloxysilicate, xanthan gum, benzyl alcohol, isopropylparaben, isobutylparaben, butylparaben, phenoxyethanol, fragrance

Other information

protect this product from excessive heat and direct sun

may stain or damage some fabrics, materials or surfaces

Questions or comments?

Call toll free 1-800-SHOP-CVS

PRINCIPAL DISPLAY PANEL

CVS HEALTH

ULTRA SHEER SPF 30 LOTION

BROAD SPECTRUM SPF 30 SUNSCREEN

UVA/UVB protection

• Light, clean & oil free
• Won't clog pores
• Water resistant (80 minutes)
• Dermatologist tested

COMPARE TO NEUTROGENA

ULTRA SHEER® DRY-TOUCH*

3.0 FL OZ (89 mL)

INGREDIENTS AND APPEARANCE

CVS HEALTH  SPF 30 ULTRA SHEER
avobenzone, homosalate, octinoxate, octisalate, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-118
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	70 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	20 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISOPROPYLPARABEN (UNII: A6EOX47QK0)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
EDETATE SODIUM (UNII: MP1J8420LU)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
GLYCERYL 1-STEARATE (UNII: 258491E1RZ)
SQUALANE (UNII: GW89575KF9)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
XANTHAN GUM (UNII: TTV12P4NEE)
POLYSORBATE 60 (UNII: CAL22UVI4M)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
WATER (UNII: 059QF0KO0R)
OAT (UNII: Z6J799EAJK)
ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S) (UNII: R9TPS68K19)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
GLYCERIN (UNII: PDC6A3C0OX)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
LEVOMENOL (UNII: 24WE03BX2T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
PEG-100 STEARATE (UNII: YD01N1999R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-118-09	89 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/24/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/24/2017

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(69842-118)