SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene lotion

Sunscreen by

Drug Labeling and Warnings

Sunscreen by is a Otc medication manufactured, distributed, or labeled by HARRIS TEETER, LLC, 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, 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, ethylhexyl palmitate, sorbitol, polyamide-8, benzyl alcohol, tocopherol, caprylic/capric triglyceride, triethanolamine, fragrance, acrylates/C10-30 alkyl acrylate crosspolymer, chlorphenesin, sodium ascorbyl phosphate, oleth-3, disodium EDTA

SPL UNCLASSIFIED SECTION

*Oxybenzone & Octinoxate free

**This product is not manufactured or distributed by Bayer, distributor of Cpppertone Sport High Performance Broad Spectrum SPF 30.

May stain or damage some fabrics or surfaces

Proudly Distributed By: Harris Teeter, LLC

Matthews, NC 28105

1-800-432-6111 or harristeeter.com

Principal display panel

Harris Teeter

SPORT

SUNSCREEN LOTION

BROAD SPECTRUM SPF 30

WATER RESISTANT (80 MINUTES)

Sweat Resistant

REEF Friendly

BPA free

COMPARE TO COPPERTONE HIGH PERFORMANCE SUNSCREEN BROAD SPECTRUM 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: 72036-714
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	50.5 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	101 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: 72036-714-34	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/02/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/02/2021

Labeler - HARRIS TEETER, LLC (047279351)

Registrant - Consumer Product Partners, LLC (119091520)

Establishment
Name	Address	ID/FEI	Business Operations
Consumer Product Partners, LLC		119091514	manufacture(72036-714)

Establishment
Name	Address	ID/FEI	Business Operations
Consumer Product Partners, LLC		119091520	manufacture(72036-714)