SHEER TOUCH SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene, oxybenzone cream

Sheer Touch Sunscreen by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredients

Avobenzone 3 %

Homosalate 10%

Octisalate 5%

Octocrylene 2.8%

Oxybenzone 6%

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 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, styrene/acrylates copolymer, silica, butyloctyl salicylate, VP/hexadecene copolymer, glyceryl stearate, PEG-100 stearate, trimethylsiloxysilicate, sodium polyacrylate, dimethicone, caprylyl methicone, benzyl alcohol, ethylhexyl stearate, behenyl alcohol, xanthan gum, chlorphenesin, trideceth-6, fragrance, disodium EDTA, BHT

SPL UNCLASSIFIED SECTION

May stain or damage some fabrics or surfaces

*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc. distributor of Neutrogena UltraSheer Dry-Touch Sunscreen Broad Spectrum SPF 55

Made in the USA with US and foreign parts

Manufactured by: Vi-Jon, Inc.,

St. Louis, MO 63114

Questions or Comments?

1-888-593-0593

www.mymountainfalls.com

760.000/760AA

principal display panel

mountain falls

Compare to Neutrogena

paraben free

SPF 55

water resistant 80 minutes

light-weight

sheer touch sunscreen

BROAD SPECTRUM

SPF 55 UVA/UVB SUNSCREEN

3 FL OZ (88 mL)

INGREDIENTS AND APPEARANCE

SHEER TOUCH SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0869-0760
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	100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	28 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	60 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I)
CETYL DIMETHICONE 150 (UNII: 5L694Y0T22)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
DIMETHICONE (UNII: 92RU3N3Y1O)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
BENZYL ALCOHOL (UNII: LKG8494WBH)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
DOCOSANOL (UNII: 9G1OE216XY)
XANTHAN GUM (UNII: TTV12P4NEE)
CHLORPHENESIN (UNII: I670DAL4SZ)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0869-0760-21	88 mL in 1 TUBE; Type 0: Not a Combination Product	09/20/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/20/2017

Labeler - Vi-Jon (790752542)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(0869-0760)