CVS HEALTH SPF 50 SUN- avobenzone, homosalate, octinoxate, 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 2.0%, Homosalate 9.0%, Octinoxate 7.5%, Octisalate 5.0%, Octocrylene 1.5%, Oxybenzone 5.0%

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

Inactive ingredients

water, C12-15 alkyl benzoate, PEG-8, adipic acid/diglycol crosspolymer, cetearyl alcohol, dicetyl phosphate, ceteth-10 phosphate, aloe barbadensis leaf juice, DEA-cetyl phosphate, propylene glycol, tocopheryl acetate (vitamin E), retinyl palmitate (vitamin A), sodium ascorbyl phosphate (vitamin C), arnica montana flower extract, chamomilla recutita (matricaria) flower extract, geranium maculatum extract, cucumis sativus (cucumber) fruit extract, euphrasia officinalis extract, tilia cordata flower extract, althaea officinalis root extract, yucca schidigera leaf/root/stem extract, hydrated silica, phenoxyethanol, methylparaben, propylparaben, isobutylparaben, butylparaben, ethylparaben, acrylates/C10-30 alkyl acrylate crosspolymer, triethanolamine, disodium EDTA, 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

SPF 50 SUN LOTION

BROAD SPECTRUM SPF 50
SUNSCREEN

UVA/UVB protection

Hypoallergenic
Water resistant (80 minutes)

16 FL OZ (473 mL)

INGREDIENTS AND APPEARANCE

CVS HEALTH  SPF 50 SUN
avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-117
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	20 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	90 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	15 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S) (UNII: R9TPS68K19)
CETYL PHOSPHATE (UNII: VT07D6X67O)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
WATER (UNII: 059QF0KO0R)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
METHYLPARABEN (UNII: A2I8C7HI9T)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ETHYLPARABEN (UNII: 14255EXE39)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
CUCUMBER (UNII: YY7C30VXJT)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ)
EUPHRASIA STRICTA (UNII: C9642I91WL)
GERANIUM MACULATUM ROOT (UNII: 93IXI5B6OJ)
TILIA CORDATA FLOWER (UNII: CFN6G1F6YK)
YUCCA SCHIDIGERA (UNII: 08A0YG3VIC)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)
TROLAMINE (UNII: 9O3K93S3TK)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-117-14	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/23/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/23/2017

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(69842-117)