OTC Medication Information: Occulus Soloxide 30 Broad Spectrum SPF 30

OCCULUS SOLOXIDE 30 BROAD SPECTRUM SPF 30- avobenzone, homosalate, octisalate, octocrylene and oxybenzone aerosol
Prime Packaging, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Avobenzone 2 %, Homosalate 7.5%, Octisalate 5 %, Octocrylene 2.75 %, and Oxybenzone 2 %

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.

Contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120°F. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if rash occurs

Flammable: Do not use near heat, flame or while smoking.

Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

Directions

  • Hold can upright. Shake well before each application.
  • Apply liberally and spread evenly by hand 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 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
  • Children under 6 months: Ask a doctor.

Inactive Ingredients

Butane, Butylparaben, Butylphthalimide, Dimethicone,Disodium EDTA, Ethylparaben, Glycerin, Isobutylparaben, Isopropylphthalimide, Methylparaben, Phenoxyethanol, Polysorbate-20, Propane, Propylene Glycol, Propylparaben, PVP, Stearic Acid, Styrene/Acrylates Copolymer, Triethanolamine, VP/Hexadecene Copolymer, Water

Other Information: •Protect this product from exessive heat and direct sun
•Avoid contact with fabrics, could cause discoloration

Questions or comments? Call toll free 1-855-317-1107

PRINCIPAL DISPLAY PANEL — 125g Can Label

PRINCIPAL DISPLAY PANEL -- 125g Can Label
(click image for full-size original)

SKIN HYDRATING

TOPICAL FOAM

SOLOXIDE 30

Broad Spectrum SPF 30

SUNSCREEN FOAM

Water resistant

(80 minutes)

NET WT.4.4 OZ (125g)

OCCULUS SOLOXIDE 30 BROAD SPECTRUM SPF 30
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone aerosol
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:13630-0089
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE (AVOBENZONE) AVOBENZONE 20 mg in 1 g
HOMOSALATE (HOMOSALATE) HOMOSALATE 75 mg in 1 g
OCTISALATE (OCTISALATE) OCTISALATE 50 mg in 1 g
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 275 mg in 1 g
OXYBENZONE (OXYBENZONE) OXYBENZONE 20 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
N-BUTYLPHTHALIMIDE
ISOPROPYLPHTHALIMIDE
DIMETHICONE
EDETATE DISODIUM
GLYCERIN
PHENOXYETHANOL
METHYLPARABEN
ETHYLPARABEN
BUTYLPARABEN
PROPYLPARABEN
ISOBUTYLPARABEN
POLYSORBATE 20
PROPYLENE GLYCOL
POVIDONE, UNSPECIFIED
STEARIC ACID
ACRYLIC ACID
TROLAMINE
VINYLPYRROLIDONE/HEXADECENE COPOLYMER
WATER
Product Characteristics
Color yellow Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13630-0089-3 125 g in 1 CAN None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 08/01/2015
Labeler — Prime Packaging, Inc. (805987059)
Registrant — Prime Packaging, Inc. (805987059)
Establishment
Name Address ID/FEI Operations
Prime Enterprises, Inc. 101946028 manufacture (13630-0089), analysis (13630-0089)
Establishment
Name Address ID/FEI Operations
Prime Packaging, Inc. 805987059 label (13630-0089), pack (13630-0089)

Revised: 01/2020 Prime Packaging, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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