Paulas Choice Calm Redness Relief SPF 30 Mineral (Normal to Oily)

Manufacturer
Paula's Choice, LLC
Effective date
2022-01-06
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 22:18:52

Label at a glance#

ProductPaulas Choice Calm Redness Relief SPF 30 Mineral (Normal to Oily)
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure7 sections

Indications and uses

Helps prevent sunburn. Decreases the risk of skin cancer and early skin aging caused by the sun if used as directed with other sun protection measures (see Directions ) Apply liberally 15 minutes before sun exposure. Reapply as needed or after towl drying, swimming or perspiring. Children under 6 months of age: ask a doctor. Sun Protection Measures Spending time in the sun increases your risk of skin cancer and ea...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 6.0%

Titanium Dioxide 2.32%

OTC - PURPOSE SECTION

Sunscreen

Uses

INSTRUCTIONS FOR USE SECTION

Helps prevent sunburn. Decreases the risk of skin cancer and early skin aging caused by the sun if used as directed with other sun protection measures (see Directions)

Directions

INSTRUCTIONS FOR USE SECTION

Apply liberally 15 minutes before sun exposure. Reapply as needed or after towl drying, swimming or perspiring. Children under 6 months of age: 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 of 25 or greater and other sun protection measures including: -limit time in the sun, espcially from 10a.m.-2p.m. -wear lnog-sleeve shirt, pants, sunglasses and a hat.

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

When usnig this product, keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash and irritation develops and lasts.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTHER SAFETY INFORMATION

If product is swallowed, get medical help or contact a Poison Control Center immediately.

Other Information

OTHER SAFETY 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), Ethylhexyl Palmitate, Cyclomethicone, Dimethicone, Glyceryl Stearate, PEG-100 Stearate, C12-15 Alkyl Benzoate, Polysorbate 80, Caprylyl Methicone, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Cetyl Alcohol, Propylene Glycol, Polyglyceryl-6 Isostearate, Allantoin, Chamomilla Recutita (Matricaria) Flower Extract, Camellia Sinensis (Green Tea) Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Alumina, Aloe Barbadensis (Aloe) Leaf Juice, Glycerin, Panthenol, Algae Extract, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Polyhydroxystearic Acid, Triethoxysilylethyl Poldimethylsiloxyethyl Hexyl Dimethicone, Caprylyl Glycol, Butylene Glycol, Diethylhexyl Carbonate, Triethoxycaprylylsilane, Disodium EDTA, Phenoxyethanol, Chlorphenesin.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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FDA-Initiated Inactive NDC Indexing#

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76144-91776144-917-01, 76144-917-02, 76144-917-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
c54df529-c326-dacd-e053-2995a90a60e91e15b225-d8b1-1702-e054-00144ff8d46c2022-01-06WarningsExact identifier
spl id: c54df529-c326-dacd-e053-2995a90a60e9
spl set id: 1e15b225-d8b1-1702-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.