Indications and uses
Helps prevent sunburn.
Foundation
- Manufacturer
- Oxygen Development LLC
- Effective date
- 2023-02-10
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 23:53:54
Label at a glance#
ProductFoundation
Active ingredientOCTINOXATE
Label structure10 sections
Dosage and administration
Apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. Children under 6 months: ask a doctor. 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 inc...
Storage and handling
Protect this product from excessive heat and direct sun. In the unlikely event of an adverse reaction, please contact 1.866.PUR.0022.
Label contents#
Full prescribing information#
Medicinal Ingredient / Active Ingredient
Octinoxate 5.0% w/w
Purpose
Sunscreen
Uses
Helps prevent sunburn.
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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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. Use a water resistant sunscreen if swimming or sweating.
Reapply at least every 2 hours. Children under 6 months: ask a doctor.
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 10am to 2 pm
Wear long-sleeved shirts, pants, hats, and sunglasses
Other
Protect this product from excessive heat and direct sun.
In the unlikely event of an adverse reaction, please contact 1.866.PUR.0022.
Non-medicinal Ingredients / Inactive Ingredients
Aqua, Cyclopentasiloxane, Propanediol, Sodium PCA, Cetyl PEG/PPG-10/1 Dimethicone,Trimethylsiloxysilicate, Boron Nitride, Dimethicone/Vinyl Dimethicone Crosspolymer, C12-15 Alkyl Ethylhexanoate, Magnesium Sulfate, Silica Silylate, Zinc Stearate, Phenoxyethanol, Mannitol, Bis-PEG/PPG-14/14 Dimethicone, Laureth-7, Amodimethicone, Lecithin, Tribehenin, Butyrospermum Parkii (Shea) Butter Extract, Sodium Starch Octenylsuccinate, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Disteardimonium Hectorite, Glucosamine HCl, Trihydroxystearin, Dimethiconol, Triethoxycaprylylsilane, Pisum Sativum (Pea) Extract, Xanthan Gum, Bambusa Vulgaris Leaf/Stem Extract, Hydroxyethylcellulose, Tocopheryl Acetate, Ethylhexylglycerin, Propylene Carbonate, Sodium Gluconate, Pentylene Glycol, Lactic Acid, Citric Acid, Sodium Citrate, Dextrin, Retinol, Waltheria Indica Leaf Extract, Ferulic Acid, EDTA, Ceramide AP, May Contain: Mica, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499).
Primary packaging
Secondary Packaging
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 61354-040-04 | 2025-01-30 | C162847 | 48780-1 | f386c64a-0db7-0266-e053-dadaa90a7c1a | PUR 4-IN-1 LIQUID 14-HOUR WEAR FOUNDATION BROAD SPECTRUM SPF 15 LIGHT |
| 61354-040-04 | 2023-02-10 | C162847 | 48780-1 | f386c64a-0db7-0266-e053-dadaa90a7c1a | PUR 4-IN-1 LIQUID 14-HOUR WEAR FOUNDATION BROAD SPECTRUM SPF 15 LIGHT |
| 61354-040-04 | 2023-01-30 | C162847 | 48780-1 | f386c64a-0db7-0266-e053-dadaa90a7c1a | PUR 4-IN-1 LIQUID 14-HOUR WEAR FOUNDATION BROAD SPECTRUM SPF 15 LIGHT |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61354-040-04 | Foundation | 1 in 1 CARTON | EMULSION | 1 | 2 | |
| 61354-040-04 | Foundation | 27 mg in 1 BOTTLE, GLASS | EMULSION | 27 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Foundation
- Octinoxate
- SILICA DIMETHYL SILYLATE
- STARCH, CORN
- WATER
- C12-15 ALKYL ETHYLHEXANOATE
- MAGNESIUM SULFATE, UNSPECIFIED FORM
- TRIBEHENIN
- LECITHIN, SOYBEAN
- CYCLOMETHICONE 5
- PROPANEDIOL
- SODIUM PYRROLIDONE CARBOXYLATE
- PHENOXYETHANOL
- TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0)
- DIMETHICONE/DIVINYLDIMETHICONE/SILSESQUIOXANE CROSSPOLYMER
- MANNITOL
- BIS-PEG/PPG-14/14 DIMETHICONE
- CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)
- MICA
- BORON NITRIDE
- ZINC STEARATE
- LAURETH-7
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 61354-040 | 61354-040-04 |
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 |
|---|---|---|---|---|---|---|
| f45d16b8-0f7a-1a9f-e053-2a95a90a0253 | bc0785c0-3f6d-3cc1-e053-2995a90aed3b | 2023-02-10 | Warnings | f45d16b8-0f7a-1a9f-e053-2a95a90a0253 bc0785c0-3f6d-3cc1-e053-2995a90aed3b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.