SUNSCREEN- avobenzone, homosalate, octisalat, octocrylene lotion

SUNSCREEN by

Drug Labeling and Warnings

SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by Retail Business Services, LLC, Vi-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Avobenzone 
Homosalate 
Octisalate
Octocrylene

Purpose

sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer

Warnings

For external use only

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
• apply to all skin exposed to the sun
• reapply: after 80 minute of swimming or sweating
• immediately after towel drying
• at least every 2 hours
• Sun Protection Measures. Spending time in the sun increases your rist of skin cancer and early skin aging.  To decrease this risk, regularly use a sunscreen with 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
• childre under 6 months of age: ask a doctor

Other information

protect the product in this container from excessive heat and dirtect sun

Inactive ingredients

water, diethylhexyl 2,6-naphthalate, styrene/acrylates copolymer, silica, glyceryl stearate, PEG-100 stearate, beeswax, cyclopentasiloxane, acrylates/dimethicone copolymer, acrylates/C10-30 alkyl acrylate crosspolymer, fragrance, chlorphenesin, benzyl alcohol, triethanolamine, disodium EDTA, BHT

ADVERSE REACTIONS

May stain or damage some fabrics or surfaces

This product is not manufactured or distributed by Johnson & Johnson Consumer, Inc., distributor of  Neutrogena Ultra Sheer Dry-Touch Sunscreen Broad Spectrum SPF 100+

DISTRIBUTED BY: ADUSA DISTRIBUTION, LLC

SALISBURY, NC 28147

1-833-992-3872

Quality guaranteed or your money back.

principal display panel

CAREONE

Compare to Neutrogena Ultra Sheer Sunscreen Broad Spectrum SPF 100+

SHEET TOUCH

Sunscreen Lotion

SPF 100

UVA/UVB PROTECTION

Broad Spectrum SPF 100

• Water resistant (80 min)
• Clean and lightweight feel
• Quickly absorbs
• Oxybenzone & Octinoxate Free Formula

NET 3 FL OZ (88 mL)

INGREDIENTS AND APPEARANCE

SUNSCREEN 
avobenzone, homosalate, octisalat, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72476-117
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	90 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	2250 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	250 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1000 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
YELLOW WAX (UNII: 2ZA36H0S2V)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
CHLORPHENESIN (UNII: I670DAL4SZ)
BENZYL ALCOHOL (UNII: LKG8494WBH)
TROLAMINE (UNII: 9O3K93S3TK)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72476-117-21	88 mL in 1 TUBE; Type 0: Not a Combination Product	11/30/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	11/30/2021

Labeler - Retail Business Services, LLC (967989935)

Registrant - Consumer Product Partners, LLC (119091520)

Establishment
Name	Address	ID/FEI	Business Operations
Consumer Product Partners, LLC		119091514	manufacture(72476-117)