FDA.reportPublic FDA data

Ounce by Ounce Lotion Broad Spectrum Sunscreen SPF 30

Manufacturer
Supergoop, LLC | Bell International Laboratories
Effective date
2022-10-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:51:15

Label at a glance#

ProductOunce by Ounce Broad Spectrum Sunscreen SPF 30
Active ingredientZINC OXIDE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients Purpose

Zinc Oxide 15.7% Sunscreen

OTC - PURPOSE SECTION

Uses

  • Helps 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

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.

INDICATIONS & USAGE SECTION

Stop use and ask a doctor if rash occurs

WARNINGS SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions

  • Apply generously and evenly 15 minutes before sun exposure
  • reapply at least every 2 hours
  • wear 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 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-sleeved shirts, pants, hats, and sunglasses
  • Children under 6 months: Ask a doctor

INACTIVE INGREDIENT SECTION

Inactive Ingredient Arachidyl Alcohol, Arachidyl Glucoside, Behenyl Alcohol, Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Calcium Sodium Borosilicate, Caprylhydroxamic Acid, Capryloyl Glycerin/Sebacic Acid Copolymer, Caprylyl Glycol, Cetearyl Alcohol, Citric Acid, Coco-Glucoside, Cocos Nucifera (Coconut) Oil, Diheptyl Succinate, Glycerin, Sodium Gluconate, Sodium Stearoyl Glutamate, Tetradecane, Tocopherol, Water, Xanthan Gum

OTHER SAFETY INFORMATION

Other Information Protect the product in this container from excessive heat and direct sun

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ounce by Ounce

Supergoop

SPF 30

Everyday Mineral Lotion

Broad Spectrum Sunscreen SPF 30

18 fl. oz. / 532 ml.

BottleBottle

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75936-158-012025-01-30C16284748780-12cef2736-9fd7-d83d-e063-dadaa90ab31fOunce by Ounce Lotion Broad Spectrum Sunscreen SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75936-158-01Ounce by Ounce Broad Spectrum Sunscreen SPF 30532 mL in 1 BOTTLELOTION5322

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75936-158OUNCE BY OUNCE BROAD SPECTRUM SUNSCREEN SPF 30 (ZINC OXIDE) LOTION [SUPERGOOP, LLC]2Legacy NDC, 1 package rows20221029_c94d68df-a80a-1d52-e053-2a95a90aa8d7.zip

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
75936-15875936-158-01

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
WATER059QF0KO0RIACT
XANTHAN GUMTTV12P4NEEIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
SHEA BUTTERK49155WL9YIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
COCO GLUCOSIDEICS790225BIACT
TETRADECANE03LY784Y58IACT
DIHEPTYL SUCCINATE057N7SS26YIACT
DOCOSANOL9G1OE216XYIACT
COCONUT OILQ9L0O73W7LIACT
ARACHIDYL GLUCOSIDE6JVW35JOOJIACT
TOCOPHEROLR0ZB2556P8IACT
LEVOMENOL24WE03BX2TIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S)N7YC58165TIACT
GLYCERINPDC6A3C0OXIACT
SODIUM GLUCONATER6Q3791S76IACT
ARACHIDYL ALCOHOL1QR1QRA9BUIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
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
ec081910-67ac-3629-e053-2995a90a65f2c94d68df-a80a-1d52-e053-2a95a90aa8d72022-10-27WarningsExact identifier
spl id: ec081910-67ac-3629-e053-2995a90a65f2
spl set id: c94d68df-a80a-1d52-e053-2a95a90aa8d7

Reported adverse events (FAERS/openFDA)#

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