Indications and uses
Helps prevent sunburn. Decreases the risk of skin cancer and early skin agining caused by the sun if used as directed with other sun protection measures (see Directions ).
Paulas Choice Calm Redness Relief SPF 30 Mineral Moisturizer (Normal to Dry)
- Manufacturer
- Paula's Choice, LLC.
- Effective date
- 2022-01-06
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-05-31 23:46:26
Label at a glance#
ProductPaulas Choice Calm Redness Relief SPF 30 Mineral Moisturizer (Normal to Dry)
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure7 sections
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Titanium Dioxide 3.85%
Zinc Oxide 3.12%
OTC - PURPOSE SECTION
Sunscreen
Uses
Helps prevent sunburn. Decreases the risk of skin cancer and early skin agining caused by the sun if used as directed with other sun protection measures (see Directions).
Warnings
For external use only. Do not use on damaged or broken skin. When using this product, keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash and irritation develops and lasts. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center immediately.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
OTC - WHEN USING SECTION
Keep out of eyes. Rinse with water to remove.
OTC - ASK DOCTOR SECTION
Stop use and ask a doctor if rash and irritation develops and lasts.
OTC - STOP USE SECTION
Stop use if rash and irritation develop and lasts.
Other Information
Store at 20-25°C (68-77°F). You may report serious adverse reactions to 705 5th Avenue South, Suite 200, Seattle, WA 98104.
INACTIVE INGREDIENT SECTION
Water (Aqua), C12-15 Alkyl Benzoate, Isononl Isononanoate, Prunus Armeniaca (Apricot) Kernel Oil, Glyceryl Stearate, PEG-100 Stearate, Cyclopentasiloxane, Butylene Glycol, Pentylene Glycol, Cetearyl Alcohol, Dimethicone, VP/Eicosene Copolymer, Glycine Soja (Soybean) Sterols, Avena Sativa (Oat) Kernel Extract, Glycerin, Sodium Hyaluronate, Allantoin, Tocopheryl Acetate, Hydrogenated Lecithin, Tetrahexyldecyl Ascorbate, Superoxide Dismutase, Ubiquinone, Ceramide NG, Methicone, Palmitoyl Hexapeptide-12, PEG-10 Dimethicone, Cucumis Sativus (Cucumber) Fruit Extract, Caprylic/Capric Triglyceride, Tibehenin, Peg-10 Phytosterol, Sorbitan Stearate, Polyhydroxystearic Acid, Alumina, Polysorbate 20, Aluminum Stearate, Xanthan Gum, Caprylyl Glycol, Disodium EDTA, Ethylhexylglycerin, Phenoxyethanol, Chlorphenesin.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 76144-913-01 | 2022-07-29 | C162847 | 48780-1 | 9d75b9d0-8adc-f424-e053-dadaa90a57ce | Paula's Choice Calm Redness Relief SPF 30 Mineral Moisturizer (Normal to Dry) |
| 76144-913-02 | 2022-07-29 | C162847 | 48780-1 | 9d75b9d0-8adc-f424-e053-dadaa90a57ce | Paula's Choice Calm Redness Relief SPF 30 Mineral Moisturizer (Normal to Dry) |
| 76144-913-03 | 2022-07-29 | C162847 | 48780-1 | 9d75b9d0-8adc-f424-e053-dadaa90a57ce | Paula's Choice Calm Redness Relief SPF 30 Mineral Moisturizer (Normal to Dry) |
| 76144-913-00 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-8adc-f424-e053-dadaa90a57ce | Paula's Choice Calm Redness Relief SPF 30 Mineral Moisturizer (Normal to Dry) |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76144-913-01 | Paulas Choice Calm Redness Relief SPF 30 Mineral Moisturizer (Normal to Dry) | 60 mL in 1 TUBE | LOTION | 60 | 4 | |
| 76144-913-02 | Paulas Choice Calm Redness Relief SPF 30 Mineral Moisturizer (Normal to Dry) | 15 mL in 1 TUBE | LOTION | 15 | 4 | |
| 76144-913-03 | Paulas Choice Calm Redness Relief SPF 30 Mineral Moisturizer (Normal to Dry) | 2 mL in 1 PACKET | LOTION | 2 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 76144-913 | PAULAS CHOICE CALM REDNESS RELIEF SPF 30 MINERAL MOISTURIZER (NORMAL TO DRY) (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PAULA'S CHOICE, LLC.] | 4 | Legacy NDC, 3 package rows | 20220107_19c2d14d-2d89-6f16-e054-00144ff8d46c.zip |
Products#
Every source-derived product name is available through these pages.
- Paulas Choice Calm Redness Relief SPF 30 Mineral Moisturizer (Normal to Dry)
- Titanium Dioxide, Zinc Oxide
- BUTYLENE GLYCOL
- PENTYLENE GLYCOL
- GLYCERIN
- GLYCERYL MONOSTEARATE
- PEG-100 STEARATE
- CYCLOMETHICONE 5
- SOY STEROL
- OAT
- .ALPHA.-TOCOPHEROL ACETATE, DL-
- UBIDECARENONE
- DIMETHICONE
- EICOSYL POVIDONE
- SUPEROXIDE DISMUTASE (SACCHAROMYCES CEREVISIAE)
- HYALURONATE SODIUM
- ALLANTOIN
- HYDROGENATED SOYBEAN LECITHIN
- TETRAHEXYLDECYL ASCORBATE
- WATER
- ISONONYL ISONONANOATE
- APRICOT KERNEL OIL
- ALKYL (C12-15) BENZOATE
- TITANIUM DIOXIDE
- ZINC OXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 76144-913 | 76144-913-01, 76144-913-02, 76144-913-03 |
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 |
|---|---|---|---|---|---|---|
| c54ddf63-3873-1525-e053-2a95a90a9853 | 19c2d14d-2d89-6f16-e054-00144ff8d46c | 2022-01-06 | Warnings | c54ddf63-3873-1525-e053-2a95a90a9853 19c2d14d-2d89-6f16-e054-00144ff8d46c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.