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NDC 44924-0901-01 Doctor Babor Protect Rx Mineral Sunscreen SPF 30 182.2 mg/mL Details

Doctor Babor Protect Rx Mineral Sunscreen SPF 30 182.2 mg/mL

Doctor Babor Protect Rx Mineral Sunscreen SPF 30 is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by BABOR Cosmetics America Corp. The primary component is ZINC OXIDE.

Product Information

NDC	44924-0901
Product ID	44924-901_d09ab135-8ca6-74ab-e053-2995a90a18bd
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Doctor Babor Protect Rx Mineral Sunscreen SPF 30
Proprietary Name Suffix	n/a
Non-Proprietary Name	Zinc Oxide
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	182.2
Active Ingredient Units	mg/mL
Substance Name	ZINC OXIDE
Labeler Name	BABOR Cosmetics America Corp
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2024-12-31

Package

Package Images

NDC 44924-0901-01 (44924090101)

Pricing Information	N/A
NDC Package Code	44924-901-01
Billing NDC	44924090101
Package	1 BOTTLE, PUMP in 1 CARTON (44924-901-01) / 30 mL in 1 BOTTLE, PUMP
Marketing Start Date	2022-02-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d09ab135-8ca5-74ab-e053-2995a90a18bd Details

Drug Facts

Active Ingredient

Zinc Oxide 18.22%

Purpose

Sunscreen

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.

Warnings

For external use only.

Do not use

on damaged or broken skin.

When using the product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

if rash occurs.

Keep out of reach of children.

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

Directions

reapply 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

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 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

protect this product from excessive heat and direct sun

Questions or comments?

You may report serious adverse event from the use of this product.

Call toll free 1-800-333-4055

Product Packaging

INGREDIENTS AND APPEARANCE

DOCTOR BABOR PROTECT RX MINERAL SUNSCREEN SPF 30

zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:44924-901
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	182.2 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
INOSITOL (UNII: 4L6452S749)
ISOSTEARIC ACID (UNII: X33R8U0062)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
PHYTATE SODIUM (UNII: 88496G1ERL)
CALCIUM GLUCONATE (UNII: SQE6VB453K)
BETA CAROTENE (UNII: 01YAE03M7J)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PROPANEDIOL (UNII: 5965N8W85T)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
C15-19 ALKANE (UNII: CI87N1IM01)
TOCOPHEROL (UNII: R0ZB2556P8)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
COCO GLUCOSIDE (UNII: ICS790225B)
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)
SODIUM BENZOATE (UNII: OJ245FE5EU)
XANTHAN GUM (UNII: TTV12P4NEE)
DOCOSANOL (UNII: 9G1OE216XY)
BETASIZOFIRAN (UNII: 2X51AD1X3T)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
PHYSALIS ALKEKENGI CALYX (UNII: AL7F9NO9HR)
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)
SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5)
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
C13-15 ALKANE (UNII: 114P5I43UJ)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
LEVOMENOL (UNII: 24WE03BX2T)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:44924-901-01	1 in 1 CARTON	02/01/2022
1		30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	02/01/2022

Labeler - BABOR Cosmetics America Corp (139251763)

Revised: 11/2021

Document Id: d09ab135-8ca6-74ab-e053-2995a90a18bd

Set id: d09ab135-8ca5-74ab-e053-2995a90a18bd

Version: 1

Effective Time: 20211112