FDA.reportPublic FDA data

DOCTOR BABOR SOLAR DEFENSE MINERAL SUNSCREEN BROAD SPECTRUM SPF 30

Manufacturer
BABOR Cosmetics America Corp
Effective date
2024-12-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:42:46

Label at a glance#

ProductDOCTOR BABOR SOLAR DEFENSE MINERAL SUNSCREEN BROAD SPECTRUM SPF 30
Active ingredientZINC OXIDE
Label structure10 sections

Indications and uses

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

Dosage and administration

Apply generously 15 minutes before sun exposure as needed. 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 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, esp...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 18.22%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin.

When using the product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

if rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply generously 15 minutes before sun exposure as needed.
  • 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 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 am to 2 pm
  • Wear longsleeved shirts, pants, hats, and sunglasses
  • Children under 6 months: Ask a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

water/aqua/eau, caprylic/capric triglyceride, C13-15 Alkane, pentylene glycol, C15-19 Alkane, propanediol, bis-diglyceryl polyacyladipate-2, gluconolactone, polyhydroxystearic acid, polyacrylate crosspolymer-6, cetearyl alcohol, inositol, isostearic acid, lecithin, polyglyceryl-3 polyricinoleate, coco-glucoside, arachidyl alcohol, polyglycerin-3, polyglyceryl-3 lactate/laurate, sodium benzoate, tocopherol, bisabolol, xanthan gum, behenyl alcohol, sodium citrate, sodium dilauramidoglutamide lysine, sclerotium gum, arachidyl glucoside, citric acid, physalis alkakengi calyx extract, sodium phytate, t-butyl alcohol, calcium gluconate, glucose, beta-carotene.

Other Information

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun

Questions or comments?

OTC - QUESTIONS SECTION

You may report serious adverse evenst from the use of this product by calling toll free 1-800-333-4055

Company Information

SPL UNCLASSIFIED SECTION

Made in the USA

Manufactured for:

BABOR Cosmetics America Corp.

2980 NE 207th St, Ste 402 Aventura,

FL 33180 www.babor.com

Product Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44924-902-01DOCTOR BABOR SOLAR DEFENSE MINERAL SUNSCREEN BROAD SPECTRUM SPF 3030 mL in 1 BOTTLE, PUMPCREAM301
44924-902-01DOCTOR BABOR SOLAR DEFENSE MINERAL SUNSCREEN BROAD SPECTRUM SPF 301 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44924-902DOCTOR BABOR SOLAR DEFENSE MINERAL SUNSCREEN BROAD SPECTRUM SPF 30 (ZINC OXIDE) CREAM [BABOR COSMETICS AMERICA CORP]1Current NDC, 2 package rows20241215_291ec801-ee15-06a4-e063-6294a90ab32b.zip

Products#

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

DailyMed product names page 1 of 1 · 36 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44924-90244924-902-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYGLYCERIN-34A0NCJ6RD6IACT
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
PROPANEDIOL5965N8W85TIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
TERT-BUTYL ALCOHOLMD83SFE959IACT
INOSITOL4L6452S749IACT
ISOSTEARIC ACIDX33R8U0062IACT
LECITHIN, SOYBEAN1DI56QDM62IACT
ARACHIDYL ALCOHOL1QR1QRA9BUIACT
PHYTATE SODIUM88496G1ERLIACT
CALCIUM GLUCONATESQE6VB453KIACT
BETA CAROTENE01YAE03M7JIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
C15-19 ALKANECI87N1IM01IACT
ZINC OXIDESOI2LOH54ZACTIB
TOCOPHEROLR0ZB2556P8IACT
GLUCONOLACTONEWQ29KQ9POTIACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S)Q7UI015FF9IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
POLYGLYCERYL-3 PENTARICINOLEATE7Q0OK5DOT4IACT
COCO GLUCOSIDEICS790225BIACT
SODIUM BENZOATEOJ245FE5EUIACT
XANTHAN GUMTTV12P4NEEIACT
DOCOSANOL9G1OE216XYIACT
BETASIZOFIRAN2X51AD1X3TIACT
ARACHIDYL GLUCOSIDE6JVW35JOOJIACT
PHYSALIS ALKEKENGI CALYXAL7F9NO9HRIACT
ANHYDROUS DEXTROSE5SL0G7R0OKIACT
SODIUM DILAURAMIDOGLUTAMIDE LYSINEMNJ7VPT2R5IACT
BIS-DIGLYCERYL POLYACYLADIPATE-26L246LAM9TIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
C13-15 ALKANE114P5I43UJIACT
PENTYLENE GLYCOL50C1307PZGIACT
LEVOMENOL24WE03BX2TIACT

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
DOCTOR BABOR SOLAR DEFENSE MINERAL SUNSCREEN BROAD SPECTRUM SPF 30ZINC OXIDEBABOR Cosmetics America Corp291ec801-ee15-06a4-e063-6294a90ab32b2024-12-12WarningsExact identifier
ndc (package): 44924-902-01
ndc (product): 44924-902
ndc11 (package): 44924090201
spl id: 291ec3bd-2575-c712-e063-6394a90aaede
spl set id: 291ec801-ee15-06a4-e063-6294a90ab32b

Reported adverse events (FAERS/openFDA)#

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