![OCCULUS SOLOXIDE 30 BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) AEROSOL [PRIME PACKAGING, INC.]](https://medic.hrt.org//dailymed/images/81aa38c6-61b3-4e47-9479-ef035e6a437b/13630-0089-3.jpg)
| NDC | 13630-0089-3 |
| Set ID | 81aa38c6-61b3-4e47-9479-ef035e6a437b |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Prime Packaging, Inc. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- Active ingredients
- Purpose
- Uses
- Warnings
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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.
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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
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INGREDIENTS AND APPEARANCE
OCCULUS SOLOXIDE 30 BROAD SPECTRUM SPF 30
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone aerosolProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13630-0089 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 20 mg in 1 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 75 mg in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 275 mg in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 20 mg in 1 g Inactive Ingredients Ingredient Name Strength N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E) ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329) DIMETHICONE (UNII: 92RU3N3Y1O) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) PHENOXYETHANOL (UNII: HIE492ZZ3T) METHYLPARABEN (UNII: A2I8C7HI9T) ETHYLPARABEN (UNII: 14255EXE39) BUTYLPARABEN (UNII: 3QPI1U3FV8) PROPYLPARABEN (UNII: Z8IX2SC1OH) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) POLYSORBATE 20 (UNII: 7T1F30V5YH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) STEARIC ACID (UNII: 4ELV7Z65AP) ACRYLIC ACID (UNII: J94PBK7X8S) TROLAMINE (UNII: 9O3K93S3TK) VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9) WATER (UNII: 059QF0KO0R) Product Characteristics Color yellow Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13630-0089-3 125 g in 1 CAN; Type 0: Not a Combination Product 08/01/2015 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 Business Operations Prime Enterprises, Inc. 101946028 manufacture(13630-0089) , analysis(13630-0089) Establishment Name Address ID/FEI Business Operations Prime Packaging, Inc. 805987059 label(13630-0089) , pack(13630-0089)
