OIL FREE MOISTURIZER- octinoxate, octisalate, avobenzone lotion

Oil Free Moisturizer by

Drug Labeling and Warnings

Oil Free Moisturizer by is a Otc medication manufactured, distributed, or labeled by Amazon.Com Services LLC, Vi-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Octinoxate 7.5%

Octisalate 5.0%

Avobenzone 3.0%

Purpose

Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the rise 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 at least every 2 hours
• use a water resistant sunscreen if swimming or sweating
• 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 highter and other sun protection measures including:
• limit the 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, octyldodecyl neopentanoate, glycerin, undecylcrylene dimethicone, emulsifying wax NF, glyceryl stearate, PEG-100 stearate, dimethicone, triethanolamine, phenoxyethanol, methylparaben, ethylparaben, propylparaben, carbomer, disodium EDTA

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY:

Amazon.com, Services, Inc

Seattle, WA 98109

1-877-485-0385

2018 Amazon.com, Inc. or its afiliated.

All rights reserved. Solimo and all related logos are are trademarks of

Amazon.com, Inc or its affiliates.

861.000/861AA

principal display panel

SOLIMO

Daily Facial Moisturizer

BROAD SPECTRUM SPF 15 SUNSCREEN

Fragrance free

4.8 FL OZ (141 mL)

INGREDIENTS AND APPEARANCE

OIL FREE MOISTURIZER 
octinoxate, octisalate, avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72288-861
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	76.5 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	51.0 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30.6 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
GLYCERIN (UNII: PDC6A3C0OX)
UNDECYLCRYLENE DIMETHICONE (10000 MW) (UNII: HA26P2LA4P)
CANDELILLA WAX (UNII: WL0328HX19)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
PEG-100 STEARATE (UNII: YD01N1999R)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIETHANOLAMINE LACTATE (UNII: 064C51N81O)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
CARBOMER 1342 (UNII: 809Y72KV36)
EDETATE SODIUM (UNII: MP1J8420LU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72288-861-26	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/01/2018
2	NDC: 72288-861-55	141 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/01/2018

Labeler - Amazon.Com Services LLC (128990418)

Registrant - Vi-Jon, LLC (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon, LLC		790752542	manufacture(72288-861)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon, LLC		088520668	manufacture(72288-861)