FDA.reportPublic FDA data

DBC SPF 30 Lotion

Manufacturer
Dimples Bath Co. LLC
Effective date
2025-01-06
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:51:05

Label at a glance#

ProductNew Kid on the Block
Active ingredientZINC OXIDE
Label structure10 sections

Indications and uses

Helps prevent sunburn. If used as directed with other sun protection measured (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

Directions • 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 protecting measures including •...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 15.7%

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn. If used as directed with other sun protection measured (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

WARNINGS SECTION

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 occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Posion Control Center immediately

Directions

DOSAGE & ADMINISTRATION SECTION

Directions • 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 protecting measures including • Limit time in the sun, especially from 1Oam - 2pm Wear long-sleeved shirts, pants, hats, and sunglasses • Children under 6 months Ask a doctor

INACTIVE INGREDIENT SECTION

Inactive Ingredients Aloe Barbadensis Leaf, Arachidyl Alcohol, Arachidyl Glucoside, Behenyl Alcohol, Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Caprylhydroxamic Acid, Capryloyl Glycerin/Sebacic Acid Copolymer, Caprylyl Glycol, Cellulose Gum, Cetearyl Alcohol, Cetyl Alcohol, Citric Acid, Coco-Glucoside, Cocos Nucifera (Coconut) OiI, Diheptyl Succinate, Glycerin, Microcrystalline Cellulose, Polyhydroxystearic Acid, Sodium Gluconate, Sodium Hyaluronate, Sodium Stearoyl Glutamate, Theobroma Cacao (Cocoa) Seed Butter*, Tocopherol, Water

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun

OTC - QUESTIONS SECTION

212-627-0377 M-F 9am to 5pm EST

SPF 30 Lotion

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SPF 30 LotionSPF 30 Lotion

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84568-553-12New Kid on the Block101.46 g in 1 TUBELOTION101.463

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84568-553NEW KID ON THE BLOCK (ZINC OXIDE) LOTION [DIMPLES BATH CO. LLC]3Current NDC, 1 package rows20250109_26fec959-c234-6692-e063-6394a90a6600.zip

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84568-55384568-553-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM GLUCONATER6Q3791S76IACT
COCOS NUCIFERA (COCONUT) OILQ9L0O73W7LIACT
SODIUM HYALURONATEYSE9PPT4THIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
DIHEPTYL SUCCINATE057N7SS26YIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
CETEARYL ALCOHOL2DMT128M1SIACT
ZINC OXIDESOI2LOH54ZACTIB
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
CITRIC ACID2968PHW8QPIACT
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S)N7YC58165TIACT
BUTYROSPERMUM PARKII (SHEA) BUTTERK49155WL9YIACT
TOCOPHEROLR0ZB2556P8IACT
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL3W1JG795YIIACT
CETYL ALCOHOL936JST6JCNIACT
BISABOLOL24WE03BX2TIACT
ARACHIDYL ALCOHOL1QR1QRA9BUIACT
THEOBROMA CACAO (COCOA) SEED BUTTER512OYT1CRRIACT
BEHENYL ALCOHOL9G1OE216XYIACT
WATER059QF0KO0RIACT
ALOE BARBADENSIS LEAFZY81Z83H0XIACT
BOROGLYCERINU3LMU4AN21IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
CELLULOSE GUMK679OBS311IACT
CAPRYLYL GLYCOL00YIU5438UIACT
COCO-GLUCOSIDEICS790225BIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
BETA-SITOSTEROLS347WMO6M4IACT
SQUALENE7QWM220FJHIACT
ARACHIDYL GLUCOSIDE6JVW35JOOJIACT

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
New Kid on the BlockZINC OXIDEDimples Bath Co. LLC26fec959-c234-6692-e063-6394a90a66002025-01-06WarningsExact identifier
ndc (package): 84568-553-12
ndc (product): 84568-553
ndc11 (package): 84568055312
spl id: 2b0c9033-7401-0695-e063-6394a90a948f
spl set id: 26fec959-c234-6692-e063-6394a90a6600

Reported adverse events (FAERS/openFDA)#

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