SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene lotion

Sunscreen by

Drug Labeling and Warnings

Sunscreen by is a Otc medication manufactured, distributed, or labeled by The Kroger Co, Vi-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 10%

Purpose

Sunscreen

Uses

• 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, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
• limit time in the sun, especiallyu 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, ethylhexyl palmitate, sorbitol, polyamide-8, benzyl alcohol, tocopherol, caprylic/capric triglyceride, triethanolamine, fragrance, acrylates/C10-30 alkyl acrylate crosspolymer, chlorphenesin, sodium ascorbyl phosphate, olethe-3, disodium EDTA

Questions or comments?

1-800-632-6900

Adverse Reaction

DISTRIBUTED BY THE KROGER CO.
CINCINNATI, OHIO 45202

Disclaimer

COPPERTONE AND COPPERTONE ULTRA GUARD ARE REGISTERED TRADEMARKS OF BAYER, WHIPPANY, NJ 07981.  BAYER IS NOT AFFILIATED WITH THE KROGER CO. OR THIS PRODUCT

May stain or damage some fabrics or surfaces.

QUALITY GUARANTEE

800-632-6900

www.kroger.com

769.000 769AA

principal display panel

compare to COPPERTONE ULTRA GUARD* See back panel

Kroger

SUNSCREEN LOTION

BROAD SPECTRUM SPF 30

UVA/UVB Sunscreen

hypoallergenic

water resistant (80 minutes

enriched with moisturizers

non-greasy

SPF

30

8 FL OZ (236 mL)

INGREDIENTS AND APPEARANCE

SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 30142-769
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30.3 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	101 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	30.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
SORBITOL (UNII: 506T60A25R)
POLYAMIDE-8 (4500 MW) (UNII: 77723GV81A)
BENZYL ALCOHOL (UNII: LKG8494WBH)
TOCOPHEROL (UNII: R0ZB2556P8)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
CHLORPHENESIN (UNII: I670DAL4SZ)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
OLETH-3 (UNII: BQZ26235UC)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 30142-769-34	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/12/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/12/2016

Labeler - The Kroger Co (006999528)

Registrant - Vi-Jon, Inc (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon, Inc		088520668	manufacture(30142-769)