MD MINERAL BB CREME BROAD SPECTRUM SPF 50 WATER RESISTANT 80 MIN- titanium dioxide, zinc oxide cream

MD Mineral BB Creme Broad Spectrum SPF 50 Water Resistant 80 Min by

Drug Labeling and Warnings

MD Mineral BB Creme Broad Spectrum SPF 50 Water Resistant 80 Min by is a Otc medication manufactured, distributed, or labeled by ENGLEWOOD LAB, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Titanium Dioxide 2%.

Zinc Oxide 17%

Purpose

Sunscreen

Uses

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

Warnings

For external use only

Do not use

on damaged or broken skin

Stop use and ask a doctor

if rash occurs

When using this product

keep out of eyes. Rinse with water to remove.

Keep out of reach of children.

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

Directions

Apply liberally 15 minutes before sun exposure : after 80 minutes of swimming or sweating  immediately after towel drying at least every 2 hours Children under 6 months: Ask a doctor Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with Broad Spectrum SPF of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10a.m. - 2p.m. Wear long-sleeved shirts, pants, hats and sunglasses


ReapplySun Protection Measures:

Other Information

Protect the product in this container from excessive heat and direct sunlight May stain some fabrics You may report serious adverse reactions to: Report Reaction, LLC., PO Box 22, Plainsboro, NJ 08536-0222 Shake well. Rub in well.

Inactive Ingredients

Dimethicone, Caprylic/Capric Triglyceride, Dimethicone Crosspolymer, Dimethicone/ Vinyl Dimethicone Crosspolymer, Butyloctyl Salicylate, Glyceryl Isostearate, Polysilicone-15, Niacinamide, Caffeine, Ubiquinone (CoQ10), Tetrahexyldecyl Ascorbate (Vitamin C), Squalane, Punica Granatum Extract (Pomegranate), Vaccinium Macrocarpon (Cranberry) Fruit Extract, Camellia Sinensis Leaf Extract (Green Tea), Silica, Polyhydroxystearic Acid, Triethoxycaprylylsilane, May Contain: (CI 77891, CI 77491, CI 77492, CI 77499)

Package Labeling:

INGREDIENTS AND APPEARANCE

MD MINERAL BB CREME BROAD SPECTRUM SPF 50 WATER RESISTANT 80 MIN 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14268-126
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	20 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	170 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
POLYSILICONE-15 (UNII: F8DRP5BB29)
NIACINAMIDE (UNII: 25X51I8RD4)
CAFFEINE (UNII: 3G6A5W338E)
UBIDECARENONE (UNII: EJ27X76M46)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
SQUALANE (UNII: GW89575KF9)
PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)
CRANBERRY (UNII: 0MVO31Q3QS)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14268-126-01	35 g in 1 TUBE; Type 0: Not a Combination Product	04/19/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/19/2023

Labeler - ENGLEWOOD LAB, INC. (172198223)

Establishment
Name	Address	ID/FEI	Business Operations
ENGLEWOOD LAB, INC.		172198223	manufacture(14268-126) , label(14268-126)