DOCTOR BABOR PROTECT RX MINERAL SUNSCREEN SPF 30- zinc oxide cream

Doctor Babor Protect Rx Mineral Sunscreen SPF 30 by

Drug Labeling and Warnings

Doctor Babor Protect Rx Mineral Sunscreen SPF 30 by is a Otc medication manufactured, distributed, or labeled by BABOR Cosmetics America Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Company Information

Made in the USA

Manufactured for:

BABOR Cosmetics America Corp.

2980 NE 207th St, Ste 402 Aventura,

FL 33180 www.babor.com

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

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PROPANEDIOL (UNII: 5965N8W85T)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
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)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	02/01/2022

Labeler - BABOR Cosmetics America Corp (139251763)