CVS HEALTH SPF 45 ULTRA SHEER- avobenzone, homosalate, octisalate, octocrylene, 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 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 2.8%, Oxybenzone 6.0%

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.

STOP USE

​Stop use and ask a 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

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

Other information

protect this product from excessive heat and direct sun

may stain or damage some fabrics, materials or surfaces

Inactive ingredients

water, butyloctyl salicylate, styrene/acrylates copolymer, silica, VP/hexadecene copolymer, dimethicone, ethylhexylglycerin, caprylyl methicone, phenoxyethanol, ethylhexyl stearate, BHT, glyceryl stearate, PEG-100 stearate, trideceth-6, behenyl alcohol, trimethylsiloxysilicate, sodium polyacrylate, xanthan gum, disodium EDTA, methylparaben, iodopropynyl butylcarbamate, propylparaben, ethylparaben, propylene glycol, fragrance

Questions or comments?

Call toll free 1-800-SHOP-CVS

PRINCIPAL DISPLAY PANEL

CVS Health

ULTRA SHEER LOTION

BROAD SPECTRUM SPF 45 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 45 ULTRA SHEER
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-122
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	28 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	60 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
METHYLPARABEN (UNII: A2I8C7HI9T)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
ETHYLPARABEN (UNII: 14255EXE39)
XANTHAN GUM (UNII: TTV12P4NEE)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
DOCOSANOL (UNII: 9G1OE216XY)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-122-09	89 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/01/2017

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(69842-122)