Occulus

Manufacturer: Prime Packaging, Inc. | Prime Enterprises, Inc.
Effective date: 2020-01-17
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 23:03:09

Label at a glance#

ProductOcculus Soloxide 30 Broad Spectrum SPF 30

Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE

Label structure7 sections

Indications and 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

Dosage and administration

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...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

OTHER SAFETY INFORMATION

For external use only. Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

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.

OTC - WHEN USING SECTION

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTHER SAFETY INFORMATION

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.

OTHER SAFETY INFORMATION

Directions

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

PRINCIPAL DISPLAY PANEL - 125g Can Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 125g Can Label

SKIN HYDRATING

TOPICAL FOAM

SOLOXIDE 30

Broad Spectrum SPF 30

SUNSCREEN FOAM

Water resistant

(80 minutes)

NET WT.4.4 OZ (125g)

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
13630-0089-3	2024-01-30	C162847	48780-1	1030e365-31b5-111a-e063-dadaa90a10e2	81aa38c6-61b3-4e47-9479-ef035e6a437b

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
13630-0089-3	OcculusSoloxide 30 Broad Spectrum SPF 30	125 g in 1 CAN	AEROSOL	125		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13630-0089	OCCULUS SOLOXIDE 30 BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) AEROSOL [PRIME PACKAGING, INC.]	3	Legacy NDC, 1 package rows	20200118_81aa38c6-61b3-4e47-9479-ef035e6a437b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
AVOBENZONE	ACTIVE INGREDIENT	G63QQF2NOX	1
HOMOSALATE	ACTIVE INGREDIENT	V06SV4M95S	1
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	1
OCTOCRYLENE	ACTIVE INGREDIENT	5A68WGF6WM	1
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	1
AVOBENZONE	ACTIVE MOIETY	G63QQF2NOX	1
HOMOSALATE	ACTIVE MOIETY	V06SV4M95S	1
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	1
OCTOCRYLENE	ACTIVE MOIETY	5A68WGF6WM	1
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	1
ACRYLIC ACID	INACTIVE INGREDIENT	J94PBK7X8S	1
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	1
ETHYLPARABEN	INACTIVE INGREDIENT	14255EXE39	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	1
ISOBUTYLPARABEN	INACTIVE INGREDIENT	0QQJ25X58G	1
ISOPROPYLPHTHALIMIDE	INACTIVE INGREDIENT	1J1MM83329	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	1
N-BUTYLPHTHALIMIDE	INACTIVE INGREDIENT	5TH1DKT35E	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	1
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	1
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	1
VINYLPYRROLIDONE/HEXADECENE COPOLYMER	INACTIVE INGREDIENT	KFR5QEN0N9	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 26 matching rows.

Occulus Soloxide 30 Broad Spectrum SPF 30
Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone
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
AVOBENZONE
HOMOSALATE
OCTISALATE
OCTOCRYLENE
OXYBENZONE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
13630-0089	13630-0089-3

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
N-BUTYLPHTHALIMIDE	5TH1DKT35E	IACT
ISOPROPYLPHTHALIMIDE	1J1MM83329	IACT
DIMETHICONE	92RU3N3Y1O	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
GLYCERIN	PDC6A3C0OX	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
ETHYLPARABEN	14255EXE39	IACT
BUTYLPARABEN	3QPI1U3FV8	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
ISOBUTYLPARABEN	0QQJ25X58G	IACT
POLYSORBATE 20	7T1F30V5YH	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
POVIDONE, UNSPECIFIED	FZ989GH94E	IACT
STEARIC ACID	4ELV7Z65AP	IACT
ACRYLIC ACID	J94PBK7X8S	IACT
TROLAMINE	9O3K93S3TK	IACT
VINYLPYRROLIDONE/HEXADECENE COPOLYMER	KFR5QEN0N9	IACT
WATER	059QF0KO0R	IACT
AVOBENZONE	G63QQF2NOX	ACTIB
HOMOSALATE	V06SV4M95S	ACTIB
OCTISALATE	4X49Y0596W	ACTIB
OCTOCRYLENE	5A68WGF6WM	ACTIB
OXYBENZONE	95OOS7VE0Y	ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 9 · 511 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	CAPSULE / ORAL	NA		Exact identifier — unii candidate 15 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / PARENTERAL		30 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / INTRAVENOUS		45 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	DROPS / NASAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	GRANULE, FOR SUSPENSION / ORAL		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	JELLY / TOPICAL		420 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CAPSULE, EXTENDED RELEASE / ORAL	0.22 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	TABLET, CHEWABLE / ORAL	0.14 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INFILTRATION		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CLOTH / TOPICAL	0.03 mg/mg		Exact identifier — unii candidate 81 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	SOLUTION / NASAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SUSPENSION / SOFT TISSUE		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / SUBCUTANEOUS	0.16 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / RECTAL		271 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / IONTOPHORESIS	0.1 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	LOTION / TOPICAL		4 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SYSTEM / TOPICAL		4200 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	FILM / BUCCAL	1.48 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, CHEWABLE / ORAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, EXTENDED RELEASE / ORAL		200 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SUSPENSION / INTRA-ARTICULAR		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	AEROSOL, FOAM / TOPICAL		72 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION/ DROPS / OPHTHALMIC		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	LOTION / TOPICAL		22 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE / ORAL		3487 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / VAGINAL		1225 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	SHAMPOO / TOPICAL	3.7 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		120 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	EMULSION / TOPICAL	0.11 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE, COATED / ORAL	14.21 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	63.4 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	POWDER / ORAL	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / EPIDURAL		30 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET / ORAL		64 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION, EXTENDED RELEASE / ORAL		2000 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SYRUP / ORAL		16734 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	TABLET / ORAL	NA		Exact identifier — unii candidate 15 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / ORAL		388 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / TOPICAL		4886 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, FILM COATED / ORAL		176 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CREAM, AUGMENTED / TOPICAL	8 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	LOTION / TOPICAL		2000 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, COATED / ORAL	1 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	EMULSION / OPHTHALMIC		3 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / VAGINAL		750 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	GEL / TOPICAL		4 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	DROPS / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SHAMPOO, SUSPENSION / TOPICAL	1 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRAVENOUS	10 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	ELIXIR / ORAL		5621 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION/ DROPS / AURICULAR (OTIC)	ADJ PH		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / AURICULAR (OTIC)	10 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	EMULSION / ORAL	NA		Exact identifier — unii candidate 26 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	TABLET, CHEWABLE / ORAL		48 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SPRAY / NASAL	22.3 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LIQUID / TOPICAL	2.5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
9c5c6bcc-c2a7-7c8b-e053-2995a90ad7f0			81aa38c6-61b3-4e47-9479-ef035e6a437b	2020-01-17	Warnings	Exact identifier spl id: 9c5c6bcc-c2a7-7c8b-e053-2995a90ad7f0 spl set id: 81aa38c6-61b3-4e47-9479-ef035e6a437b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.