AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE lotion

Avobenzone, Homosalate, Octisalate, Octocrylene by

Drug Labeling and Warnings

Avobenzone, Homosalate, Octisalate, Octocrylene by is a Otc medication manufactured, distributed, or labeled by Vi-Jon, Inc. 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

principal display panel

mountain

falls

*Compare to

Coppertne

non-greasy

SPF 30

Water

Resistant

80 minutes

sport

sunscreen

lotion

BROAD

SPECTRUM

SPF 50

Made in the USA with US nd foreign parts

INGREDIENTS AND APPEARANCE

AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0869-0714
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: 0869-0714-18	74 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/28/2016
2	NDC: 0869-0714-34	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/28/2016
3	NDC: 0869-0714-38	296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/28/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	11/28/2016

Labeler - Vi-Jon, Inc (790752542)

Registrant - Vi-Jon, Inc (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon, Inc		790752542	manufacture(0869-0714)