FDA.reportPublic FDA data

Seriously Soothing SPF Day Cream

Manufacturer
Better Planet Brands LLC
Effective date
2025-12-03
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:19:14

Label at a glance#

ProductSeriously Soothing SPF Day 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 at least every 2 hours use a water-resistant sunscreen if swimming or sweating. 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, especi...

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 useon 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 doctorif 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 at least every 2 hours use a water-resistant sunscreen if

swimming or sweating. 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-sleeveshirts, pants, hats, and sunglasses

Other information

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun. • May stain some fabrics.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

WATER, COCO-CAPRYLATE/CAPRATE, CELEARYL OLIVATE, SORBITAN OLIVATE, NIACINAMIDE, PANTHENOL, TOCOPHERYL ACETATE, TANACETUM ANNUUM FLOWER OIL, LAUROYL LYSINE, LECITHIN, PULLULAN, SCLEROTIUM GUM, XANTHAN GUM, CETEARYL ALCOHOL, POLYHYDROXYSTEARIC ACID, SILICA, SODIUM PHYTATE, DEHYDROACETIC ACID, BENZYL ALCOHOL

Questions?

OTC - QUESTIONS SECTION

Call toll-free 877.902.2873

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BoxBox

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54136-179-52Seriously Soothing SPF Day Cream52 g in 1 TUBECREAM524

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54136-17954136-179-52

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
LAUROYL LYSINE113171Q70BIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
BENZYL ALCOHOLLKG8494WBHIACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
TANACETUM ANNUUM FLOWERING TOP OILE2Q02N1ZC7IACT
PANTHENOLWV9CM0O67ZIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
TOCOPHEROLR0ZB2556P8IACT
BETASIZOFIRAN2X51AD1X3TIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
GLYCERINPDC6A3C0OXIACT
PULLULAN8ZQ0AYU1TTIACT
SORBITAN OLIVATEMDL271E3GRIACT
XANTHAN GUMTTV12P4NEEIACT
CETEARYL OLIVATE58B69Q84JOIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
WATER059QF0KO0RIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
DEHYDROACETIC ACID2KAG279R6RIACT
NIACINAMIDE25X51I8RD4IACT
HEXASODIUM PHYTATEZBX50UG81VIACT
ZINC OXIDESOI2LOH54ZACTIB

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
Seriously Soothing SPF Day CreamZINC OXIDEBetter Planet Brands LLC1d8d47f6-907d-ab31-e063-6394a90a05d82025-12-03WarningsExact identifier
ndc (package): 54136-179-52
ndc (product): 54136-179
ndc11 (package): 54136017952
spl id: 451319cd-8d9a-8e63-e063-6394a90a11e7
spl set id: 1d8d47f6-907d-ab31-e063-6394a90a05d8

Reported adverse events (FAERS/openFDA)#

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