CVS HEALTH ULTRA PROTECTION SPF 70- 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 15.0%, Octisalate 5.0%, Octocrylene 10.0%, 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 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, Butylene Glycol, Microcrystalline Cellulose, Glyceryl Stearate, Behenyl Alcohol, Benzyl Alcohol, Diethylhexyl Syringylidenemalonate, Tocopherol (Vitamin E), Retinyl Palmitate (Vitamin A), Sodium Ascorbyl Phosphate, Stearic Acid, Palmitic Acid, Lauryl Alcohol, Myristyl Alcohol, Cetyl Alcohol, Lecithin, Caprylic/Capric Triglyceride, Chlorphensin, Cellulose Gum, Butylated PVP, Disodium EDTA

Questions or comments?

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PRINCIPAL DISPLAY PANEL

CVS Health

Ultra Protection

Sun Lotion

SPF 70

BROAD SPECTRUM SPF 70 SUNSCREEN

UVA/UVB protection

Hypoallergenic

Non-greasy

Water resistant (80 minutes)

Dermatologist tested

COMPARE TO COPPERTONE®

ultraGUARD® SPF 70 LOTION*

8 FL OZ (237 mL)

INGREDIENTS AND APPEARANCE

CVS HEALTH  ULTRA PROTECTION SPF 70
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-157
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	150 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
TOCOPHEROL (UNII: R0ZB2556P8)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DOCOSANOL (UNII: 9G1OE216XY)
BENZYL ALCOHOL (UNII: LKG8494WBH)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
STEARIC ACID (UNII: 4ELV7Z65AP)
PALMITIC ACID (UNII: 2V16EO95H1)
LAURYL ALCOHOL (UNII: 178A96NLP2)
MYRISTYL ALCOHOL (UNII: V42034O9PU)
CETYL ALCOHOL (UNII: 936JST6JCN)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
CHLORPHENESIN (UNII: I670DAL4SZ)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-157-11	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/25/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/25/2018

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(69842-157)