AVOBENZONE, HOMOSALATE, OCTISALATE lotion

Avobenzone, Homosalate, Octisalate by

Drug Labeling and Warnings

Avobenzone, Homosalate, Octisalate by is a Otc medication manufactured, distributed, or labeled by DOLLAR GENERAL CORPORATION, Vi-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 3%

Homosalate 15%

Octisalate 5%

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

• 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 right away.

Directions

• apply liberaly 15 minutes before sun exposure
• apply to all skin exposed to the sun
• 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 Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
• limit time in the sun, especialy 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 in this container from excessive heat and direct sun

Inactive ingredients

water, butyloctyl salicylate, diethylhexyl 2,6-naphthalate, styrene/acrylates copolymer, silica, glyceryl stearate, PEG-100 stearate, dimethicone, potassium cetyl phosphate, benzyl alcohol, beeswax, caprylyl methicone, aluminum starch octenylsuccinate, cetyl dimethicone, behenyl alcohol, acrylates/C12-22 alkyl methacrylate copolymer, xanthan gum, chlorphenesin, dimethicone/PEG-10/15 crosspolymer, sodium polyacrylate, fragrance, glycerin, disodium EDTA, ethylhexyl stearate, tocopheryl acetate, BHT, trideceth-6, pentylene glycol, benzyl benzoate

Claims

This product is not manufacturedor distributed by Johnson & Johnson Corporation., distributor of Neutrogena Ultra Sheer Dry-Touch Sunscreen Broad Spectrum SPF 70.

May stain or damage some fabrics or surfaces.

Adverse Reactions

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(888) 309-9030

DISTRIBUTED BY

OLD EAST MIN CO.

100 MISSION RIDGE,

GOODLETTSVILLE, TN 37072

Principal display panel

STUDIO SELECTION

SUN

SHEER TOUCH

SUNSCREEN

SUNSCREEN LOTION

BROAD SPECTRUM SPF 70

COMPARE TO NEUTROGENA® ULTRA SHEER® SUNSCREEN Broad Spectrum SPF 70*

• Water-Resistant (80 Minutes)
• Lightweight, clean skin feel

SPF 70

Dermatologist-Tested 

UVA/UVB Sunscreen

3 FL OZ (88 mL)

INGREDIENTS AND APPEARANCE

AVOBENZONE, HOMOSALATE, OCTISALATE 
avobenzone, homosalate, octisalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75712-935
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	150 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
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)
DIMETHICONE (UNII: 92RU3N3Y1O)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
BENZYL ALCOHOL (UNII: LKG8494WBH)
YELLOW WAX (UNII: 2ZA36H0S2V)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
CETYL DIMETHICONE 150 (UNII: 5L694Y0T22)
DOCOSANOL (UNII: 9G1OE216XY)
BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P)
XANTHAN GUM (UNII: TTV12P4NEE)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
GLYCERIN (UNII: PDC6A3C0OX)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
BENZYL BENZOATE (UNII: N863NB338G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75712-935-21	88 mL in 1 TUBE; Type 0: Not a Combination Product	08/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/01/2023

Labeler - DOLLAR GENERAL CORPORATION (006946172)

Registrant - Vi-Jon, LLC (088520668)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon, LLC		790752542	manufacture(75712-935)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon, LLC		088520668	manufacture(75712-935)