SOLIMO KIDS SPF 50 BROAD SPECTRUM SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene aerosol, spray

SOLIMO KIDS SPF 50 BROAD SPECTRUM SUNSCREEN by

Drug Labeling and Warnings

SOLIMO KIDS SPF 50 BROAD SPECTRUM SUNSCREEN 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 10.0%

Octisalate 5.0%

Octocrylene 4.0%

Purpose

Sunscreen

INDICATIONS & USAGE

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 casued by the sun

Warnings

For external use only

FLAMMABLE:

• do not use near heat, flame or while smoking
• avoid long term storage above 104ºF (40ºC)

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.
• keep away from face to avoid breathing it.
• do not puncture or incinerate. Contents under pressure.
• do not store at temperatures above 120ºF.

ASK DOCTOR

Stop use and ask a doctor if

• rash occurs.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Spray liberally and spread evenly by hand 15 minutes before sun exposure

Hold can 4-6 inches away from the skin to apply

Do not spray directly into face. Spray into hands then apply to face

Do not apply in windy conditions

Use in a well-ventilated area

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

alcohol denat., butyloctyl salicylate, acrylates/octylacrylamide copolymer, panthenol, tocopherol, fragrance, stearoxytrimethylsilane, caprylic/capric triglyceride, glycerin

Questions or comments?

Call toll free 1-877-485-0385

PRINCIPAL DISPLAY PANEL

SOLIMO SPORT SPF 50 BROAD SPECTRUM SUNSCREEN SPRAY

11 OZ. (312g)

NDC: 72288-209-38

INGREDIENTS AND APPEARANCE

SOLIMO KIDS SPF 50 BROAD SPECTRUM SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72288-210
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	40 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
TOCOPHEROL (UNII: R0ZB2556P8)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ALCOHOL (UNII: 3K9958V90M)
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)
PANTHENOL (UNII: WV9CM0O67Z)
STEAROXYTRIMETHYLSILANE (UNII: 9862TW94B2)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72288-210-38	312 g in 1 CAN; Type 0: Not a Combination Product	05/28/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/28/2020

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(72288-210)