Solimo 914.000/914aa

Solimo 914.000/914aa
SPL v13
SPL
SPL Set ID bb0de0bb-5058-4e3b-bb9d-6f1f1d3e224d
Route
TOPICAL
Published
Effective Date 2025-07-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (100 mg) Octisalate (50 mg) Octocrylene (60 mg)
Inactive Ingredients
Water Silicon Dioxide Dimethicone Potassium Cetyl Phosphate Benzyl Alcohol Yellow Wax Glyceryl Monostearate Peg-100 Stearate Caprylyl Trisiloxane Cetyl Dimethicone 150 Dimethicone/peg-10/15 Crosspolymer Sodium Polyacrylate (8000 Mw) Docosanol Xanthan Gum Glycerin Pentylene Glycol Allyl Methacrylate Ethylhexyl Stearate Chlorphenesin Edetate Disodium Anhydrous Diethylhexyl 2,6-naphthalate Butylated Hydroxytoluene Trideceth-6

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-09-08

Description

Avobenzone 3% Homosalate 10% Octisalate 5% Octocrylene 6%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage
  • 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
Dosage and Administration

■ apply liberally 15 minutes before sun exposure

■ apply to all skin exposed to the sun

■ 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

Description

Avobenzone 3% Homosalate 10% Octisalate 5% Octocrylene 6%

Section 34084-4

May stain or damage some fabrics or surfaces

DISTRIBUTED BY:

Amazon.com Services, LLC

Seattle, WA 98109

1-877-485-0385

©2019 Amazon.com, Inc or it affiliates. All rights reserved

Section 50565-1

If swallowed, get medical help or contact a Poison Control right away.

Section 50566-9
  • rash occurs
Section 50567-7
  • keep out of eyes.  Rinse with water to remove.
Section 50570-1
  • on damaged or broken skin
Section 51727-6

water, silica, dimethicone, potassium cetyl phosphate, benzyl alcohol, beeswax, glyceryl stearate, PEG-100 stearate, caprylyl methicone, cetyl dimethicone, dimethicone/PEG-10/15 crosspolymer, sodium polyacrylate, behenyl alcohol, xanthan gum, glycerin, pentylene glycol, acrylates/C12-22 alkyl methacrylate copolymer, ethylhexyl stearate, chlorphenesin, disodium EDTA, fragrance, diethylhexyl 2,6-naphthalate, BHT, trideceth-6

Section 51945-4

Solimo

Sheer Facial

Sunscreen

Lotion

BROAD SPECTRUM SPF 30

Water Resistant (80 minutes)

Light, clean feel

Dermatologist tested

Oxybenzone & Octinoxate free

3 FL OZ (88 mL)

Section 55105-1

Sunscreen

Section 55106-9

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 6%

Section 60561-8
  • protect the product in this container from excessive heat and direct sun

Structured Label Content

Indications and Usage (34067-9)
  • 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
Dosage and Administration (34068-7)

■ apply liberally 15 minutes before sun exposure

■ apply to all skin exposed to the sun

■ 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

Warnings and Precautions (34071-1)

For external use only

Section 34084-4 (34084-4)

May stain or damage some fabrics or surfaces

DISTRIBUTED BY:

Amazon.com Services, LLC

Seattle, WA 98109

1-877-485-0385

©2019 Amazon.com, Inc or it affiliates. All rights reserved

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison Control right away.

Section 50566-9 (50566-9)
  • rash occurs
Section 50567-7 (50567-7)
  • keep out of eyes.  Rinse with water to remove.
Section 50570-1 (50570-1)
  • on damaged or broken skin
Section 51727-6 (51727-6)

water, silica, dimethicone, potassium cetyl phosphate, benzyl alcohol, beeswax, glyceryl stearate, PEG-100 stearate, caprylyl methicone, cetyl dimethicone, dimethicone/PEG-10/15 crosspolymer, sodium polyacrylate, behenyl alcohol, xanthan gum, glycerin, pentylene glycol, acrylates/C12-22 alkyl methacrylate copolymer, ethylhexyl stearate, chlorphenesin, disodium EDTA, fragrance, diethylhexyl 2,6-naphthalate, BHT, trideceth-6

Section 51945-4 (51945-4)

Solimo

Sheer Facial

Sunscreen

Lotion

BROAD SPECTRUM SPF 30

Water Resistant (80 minutes)

Light, clean feel

Dermatologist tested

Oxybenzone & Octinoxate free

3 FL OZ (88 mL)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 6%

Section 60561-8 (60561-8)
  • protect the product in this container from excessive heat and direct sun

Advanced Ingredient Data


Raw Label Data

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