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.
OP Protect and Renew Body SPF 45
- Manufacturer
- SolSkyn Personal Care LLC
- Effective date
- 2017-02-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:48:39
Label at a glance#
ProductOP Protect and Renew Body SPF 45
Active ingredientAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE
Label structure13 sections
Dosage and administration
• Apply liberally 15 minutes before sun exposure. • Re-apply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every two 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 mea...
Storage and handling
• Protect this product from excessive heat and direct sun. • For use on skin only. Avoid contact with fabric.
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
OP Protect & Renew Body SPF 45
Active Ingredients
Avobenzone 3.0%
Active Ingredients
Homosalate 15.0%
Active Ingredients
Octocrylene 2.35%
Active Ingredients
Octyl Salicylate 5.0%
Active Ingredients
Oxybenzone 5.0%
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.
• Stop use and ask a doctor if rash occurs.
• When using this product keep out of eyes. Rinse with water to remove.
• Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions:
• Apply liberally 15 minutes before sun exposure.
• Re-apply:
• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every two 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: ask a doctor.
Inactive Ingredients
Acrylates/C10-30 Alkyl Acrylate Crossolymer, Butylparaben, Caprylyl Methicone, Citric Acid, Diisostearyl Malate, Disodium EDTA, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Hyrdogenated Coco-Glycerides, Niacinamide, PEG-100 Stearate, Phenoxyethanol, Potassium Cetyl Phosphate, PPG-17/IPDI/DMPA Coploymer, Polydimethylsiloxane, Saccaride Isomerate, Silica, Sodium Citrate, Tocopheryl Acetate, Triethanolamine, Water
Other Information
• Protect this product from excessive heat and direct sun.
• For use on skin only. Avoid contact with fabric.
PRINCIPAL DISPLAY PANEL
Ocean Potion
Protect
& Renew
Body
SPF 45
6 fl oz (177 mL)
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 70281-212-14 | 2020-09-27 | C162847 | 48780-1 | ab0e2407-3697-f274-e053-dbdaa90a6471 | OP-SPF45 6oz Protect Renew Body 72-hr Moisture |
| 70281-212-14 | 2020-09-25 | C162847 | 48780-1 | ab0e2407-3697-f274-e053-dbdaa90a6471 | OP-SPF45 6oz Protect Renew Body 72-hr Moisture |
| 70281-212-14 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-3697-f274-e053-dbdaa90a6471 | OP-SPF45 6oz Protect Renew Body 72-hr Moisture |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70281-212-14 | OP Protect and Renew Body SPF 45 | 170 g in 1 CONTAINER | LOTION | 170 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70281-212 | OP PROTECT AND RENEW BODY SPF 45 (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTYL SALICYLATE, OXYBENZONE) LOTION [SOLSKYN PERSONAL CARE LLC] | 1 | Legacy NDC, 1 package rows | 20170131_08c42592-29d8-485c-8897-5599f983ba98.zip |
Products#
Every source-derived product name is available through these pages.
- OP Protect and Renew Body SPF 45
- Avobenzone, Homosalate, Octocrylene, Octyl Salicylate, Oxybenzone
- AVOBENZONE
- HOMOSALATE
- OCTOCRYLENE
- OCTISALATE
- OXYBENZONE
- CARBOMER INTERPOLYMER TYPE A (55000 CPS)
- BUTYLPARABEN
- CAPRYLYL TRISILOXANE
- CITRIC ACID MONOHYDRATE
- DIISOSTEARYL MALATE
- EDETATE DISODIUM ANHYDROUS
- ETHYLHEXYLGLYCERIN
- GLYCERIN
- GLYCERYL MONOSTEARATE
- HYDROGENATED COCO-GLYCERIDES
- NIACINAMIDE
- PEG-100 STEARATE
- PHENOXYETHANOL
- POTASSIUM CETYL PHOSPHATE
- DIMETHICONE
- SACCHARIDE ISOMERATE
- SILICON DIOXIDE
- SODIUM CITRATE
- .ALPHA.-TOCOPHEROL ACETATE
- TROLAMINE
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70281-212 | 70281-212-14 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 7a1634d2-0b22-4a67-b230-c6f6d0d400f7 | 08c42592-29d8-485c-8897-5599f983ba98 | 2017-02-01 | Warnings | 7a1634d2-0b22-4a67-b230-c6f6d0d400f7 08c42592-29d8-485c-8897-5599f983ba98 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.