Seriously Soothing Face Cream

Manufacturer
Better Planet Brands LLC
Effective date
2024-07-22
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 20:58:28

Label at a glance#

ProductSeriously Soothing Face Cream
Active ingredientZINC OXIDE
Label structure9 sections

Indications and uses

* Help 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.

Dosage and administration

* apply liberally 15 minutes before sun exposure * reapply: * 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: * ...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 15.50%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

* Help 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

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

When using the product * keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed get medical help or contact a Poison Control Center right away.

May stain some fabrics.

Directions

DOSAGE & ADMINISTRATION SECTION

* apply liberally 15 minutes before sun exposure

* reapply:

* 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-sleeve shirts, pants, hats, and sunglasses

Other information

OTHER SAFETY INFORMATION

* Protect this product from excessive heat and direct sun

INACTIVE INGREDIENT SECTION

Inactive Ingredients Water (Eau), Coconut Alkanes, Glycerin, Squalane, Cetearyl Olivate, Cetearyl Alcohol, Sorbitan Olivate, Panthenol, Tocopherol, Niacinamide, Tanacetum Annuum Flower Oil, Aloe Barbadensis Leaf Juice, Butyrospermum Parkii (Shea) Butter, Cocos Nucifera (Coconut) Oil, Glycine Soja (Soybean) Oil, Argania Spinosa Kernel Oil, Sodium PCA, Allantoin, Lecithin, Bisabolol, Pullulan, Xanthan Gum, Sclerotium Gum, Caprylyl Glycol, Coco-Caprylate/Caprate, Heptyl Undecylenate, Polyhydrostearic Acid, Cetearyl Glucoside, Silica, Hexylene Glycol, Caprylhydroxamic Acid, Ethylhexylglycerin.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-902-2873

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Face cream boxFace cream boxFace cream tubeFace cream tube

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54136-946SERIOUSLY SOOTHING FACE CREAM (ZINC OXIDE) CREAM [BETTER PLANET BRANDS LLC]6Legacy NDC20240724_a3e5308a-f89d-d053-e053-2995a90abf84.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54136-94654136-946-19

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 · Source PDF

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
1ddc387c-aac5-b9bd-e063-6294a90aa7c4a3e5308a-f89d-d053-e053-2995a90abf842024-07-22WarningsExact identifier
spl id: 1ddc387c-aac5-b9bd-e063-6294a90aa7c4
spl set id: a3e5308a-f89d-d053-e053-2995a90abf84

Reported adverse events (FAERS/openFDA)#

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