SOLIMO GENERAL PROTECTION SPF 50 SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Solimo by

Drug Labeling and Warnings

Solimo by is a Otc medication manufactured, distributed, or labeled by Amazon.com Services LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3.0%, Homosalate 13.0%, Octisalate 5.0%, Octocrylene 7.0%, Oxybenzone 4.0%

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

​Do not use

• ​​on damaged or broken skin

WHEN USING

When using this product keep out of eyes. Rinse with water to remove.

STOP USE

​Stop use and ask doctor if​

• rash occurs.

KEEP OUT OF REACH OF CHILDREN

​Keep out of reach of children. ​If product is 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
children under 6 months of age: ask a doctor
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 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-sleeve shirts, pants, hats, and sunglasses

Other Information

protect this product from excessive heat and direct sun

may stain or damage some fabrics, materials or surfaces

Inactive ingredients

water, sorbitol, VP/eicosene copolymer, stearic acid, triethanolamine, aluminum starch octenylsuccinate, sorbitan isostearate, benzyl alcohol, dimethicone, tocopherol, polyglyceryl-3 distearate, phenoxyethanol, caprylyl glycol, ethylhexylglycerin, carbomer, disodium EDTA, fragrance

Questions or comments?

Call toll free 1-877-485-0385

Solimo General Protection SPF 50 Sunscreen Lotion

INGREDIENTS AND APPEARANCE

SOLIMO  GENERAL PROTECTION SPF 50 SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72288-208
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	130 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	70 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
STEARIC ACID (UNII: 4ELV7Z65AP)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
TOCOPHEROL (UNII: R0ZB2556P8)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
SORBITOL (UNII: 506T60A25R)
TROLAMINE (UNII: 9O3K93S3TK)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIMETHICONE (UNII: 92RU3N3Y1O)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72288-208-40	308 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/02/2018
2	NDC: 72288-208-41	616 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/02/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/02/2018

Labeler - Amazon.com Services Inc. (128990418)

Registrant - Fruit Of The Earth, Inc. (079559467)

Establishment
Name	Address	ID/FEI	Business Operations
Fruit Of The Earth Research Laboratories, Inc.		008193513	manufacture(72288-208)