Ultra Sunscreen Lotion SPF 50711.000/711AA

Sunscreen by

Drug Labeling and Warnings

Sunscreen by is a Otc medication manufactured, distributed, or labeled by American Sales Company, Vi-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion 
American Sales Company

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Ultra Sunscreen Lotion SPF 50
711.000/711AA

Active Ingredients

Avobenzone 3%

Homosalate 13%

Octisalate 5%

Octocrylene 7%

Oxybenzone 4%

Purpose

Sunscreen

Use

• helps prevent sunburn
• if used as directed with other sun protections measures (see Directions), decreases the rist of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Do not use

• on damaged or broken skin

When using this product

• keep out of eyes.  Rinse with water to remove

Stop use and ask a doctor if

• rash occurs

Keep out of reach of children

if 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 use a  reqularly use a sunscreen with a Broad Spectrum SPF value 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-sleeved shirts, pants, hats and sunglasses
• children under 6 months of age: Ask a doctor

Other Information

• Protect the product from excessive heat and direct sun

Inactive ingredients

water, sorbitol, triethanolamine, VP/eicosene copolymer, stearic acid, sorbitan isostearate, aluminum starch octenylsuccinate, benzyl alcohol, dimethicone, tocopheryl, chlorphenesin, polyglyceryl-3 distearate, fragrance, carbomer, disodium EDTA

Questions or comments?

1-800-632-6900

*This product is ot manufactured or distributed by Bayer, distributor of Coppertone

May stain or damage some fabrics or surfaces.

PROUDLY DISTRIBUTED BY:

VALU MERCHANDISERS, CO.

5000 KANSAS AVE

KANSAS CITY, MO 66106

711.001/711AB rev 1

principal display panel

Care One Sunscreen Lotion

Compare to Coppertone Ultra Guard Sunscreen Lotion SPF 50*

SPF 50 UVA/UVB Protection

Broad Spectrum SPF 50

Water Resistant (80 minutes)

Enriched with moisturizers

Hypoallergenic

8 FL OZ (236 mL)

SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41520-811
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	130 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	70 mg  in 1 mL
oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	oxybenzone	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
TROLAMINE (UNII: 9O3K93S3TK)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
STEARIC ACID (UNII: 4ELV7Z65AP)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
BENZYL ALCOHOL (UNII: LKG8494WBH)
DIMETHICONE (UNII: 92RU3N3Y1O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHLORPHENESIN (UNII: I670DAL4SZ)
POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41520-811-34	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/12/2016	08/03/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/12/2016	08/03/2021

Labeler - American Sales Company (809183973)

Registrant - Vi-Jon, LLC (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon, LLC		088520668	manufacture(41520-811)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon, LLC		790752542	manufacture(41520-811)

Revised: 10/2023

Document Id: 44017bd3-26e8-4295-b83e-aaa51e314074

34390-5

Set id: 32b41a6b-7be2-4a2f-8b29-472c84bcc56e

Version: 3

Effective Time: 20231023