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 Nourish Babies and Sensitive SPF 50
- Manufacturer
- SolSkyn Personal Care LLC | KIK Custom Products – Rexdale plant
- Effective date
- 2018-02-15
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 22:54:32
Label at a glance#
ProductOP Protect and Nourish Babies and Sensitive SPF 50
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure12 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 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 measu...
Storage and handling
• For use on skin only. Avoid contact with fabric. • Protect this product from excessive heat and direct sun.
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
OP Protect & Nourish Babies & Sensitive SPF 50
Active Ingredients
Avobenzone 3.0%
Active Ingredients
Homosalate 15.0%
Active Ingredients
Octisalate 5.0%
Active Ingredients
Octocrylene 7.0%,
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 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: ask a doctor.
Inactive Ingredients
Acrylates / C10-30 Alkyl Acrylate Crosspolymer, Acrylates Copolymer, Carbomer, Cholecalciferol, Diisopropyl Adipate, Dimethyl Capramide, Disodium EDTA, Hydroxypropyl Methylcellulose, Idopropynyl Butylcarbamate, Macrocystis Pyrifera Extract, Phenoxyethanol, Polyester-8, Propylene Glycol, Sorbitan Oleate, Tocopheryl Acetate, Triethanolamine, Water
Other Information:
• For use on skin only. Avoid contact with fabric.
• Protect this product from excessive heat and direct sun.
PRINCIPAL DISPLAY PANEL
Ocean Potion
Protect
& Nourish
Vitamin D3
Babies &
Sensitive
SPF 50
8 fl oz (237 mL)
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 60c52429-fcef-eb54-2387-43bc9e4f296b | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 70281-215-24 | 2020-09-27 | C162847 | 48780-1 | ab0e2407-3671-f274-e053-dbdaa90a6471 | OP Baby Sensitive Sunscreen Ltn 50 |
| 70281-215-24 | 2020-09-25 | C162847 | 48780-1 | ab0e2407-3671-f274-e053-dbdaa90a6471 | OP Baby Sensitive Sunscreen Ltn 50 |
| 70281-215-24 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-3671-f274-e053-dbdaa90a6471 | OP Baby Sensitive Sunscreen Ltn 50 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70281-215-24 | OP Protect and Nourish Babies and Sensitive SPF 50 | 227 g in 1 CONTAINER | LOTION | 227 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70281-215 | OP PROTECT AND NOURISH BABIES AND SENSITIVE SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [SOLSKYN PERSONAL CARE LLC] | 2 | Legacy NDC, 1 package rows | 20180213_c7938795-685b-4b7c-84ce-0ea66b64576e.zip |
Products#
Every source-derived product name is available through these pages.
- OP Protect and Nourish Babies and Sensitive SPF 50
- Avobenzone, Homosalate, Octisalate, Octocrylene
- AVOBENZONE
- HOMOSALATE
- OCTISALATE
- OCTOCRYLENE
- CARBOMER INTERPOLYMER TYPE A (55000 CPS)
- CARBOXYPOLYMETHYLENE
- CHOLECALCIFEROL
- DIISOPROPYL ADIPATE
- DIMETHYL CAPRAMIDE
- EDETATE DISODIUM ANHYDROUS
- HYPROMELLOSES
- IODOPROPYNYL BUTYLCARBAMATE
- MACROCYSTIS PYRIFERA
- PHENOXYETHANOL
- POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)
- PROPYLENE GLYCOL
- SORBITAN MONOOLEATE
- ALPHA-TOCOPHEROL ACETATE
- TROLAMINE
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70281-215 | 70281-215-24 |
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 |
|---|---|---|---|---|---|---|
| 2245d489-0033-4045-9265-5a1f789bbc49 | c7938795-685b-4b7c-84ce-0ea66b64576e | 2018-02-15 | Warnings | 2245d489-0033-4045-9265-5a1f789bbc49 c7938795-685b-4b7c-84ce-0ea66b64576e |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.