CVS HEALTH SPF 55 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 3.0%, Octocrylene 7.0%, 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

Inactive ingredients

water, butyloctyl salicylate, styrene/acrylates copolymer, silica, polysilicone-15, VP/hexadecene copolymer, behenyl alcohol, glyceryl stearate, PEG-100 stearate, dimethicone, ethylhexylglycerin, caprylyl methicone, phenoxyethanol, ethylhexyl stearate, BHT, trideceth-6, trimethylsiloxysilicate, sodium polyacrylate, xanthan gum, disodium EDTA, methylparaben, iodopropynyl butylcarbamate, ethylparaben, propylparaben, propylene glycol, 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 LOTION

BROAD SPECTRUM SPF 55 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 55 ULTRA SHEER
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-112
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	70 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	30 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
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)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
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)
POLYSILICONE-15 (UNII: F8DRP5BB29)
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)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-112-08	89 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/12/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/12/2017

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(69842-112)