Bareminerals ®

Bareminerals ®
SPL v4
SPL
SPL Set ID 3cc5b952-4619-4395-97c0-5b68efa9af6d
Route
TOPICAL
Published
Effective Date 2021-08-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (780 mg) Zinc Oxide (1860 mg)
Inactive Ingredients
Cyclomethicone 5 Dimethicone Crosspolymer (450000 Mpa.s At 12% In Cyclopentasiloxane) Hydrogenated Polydecene Type I Dimethicone Styrene/acrylamide Copolymer (500000 Mw) Hexyl Laurate Polyglyceryl-4 Isostearate Ferric Oxide Red Peg-10 Dimethicone (600 Cst) Stearic Acid Aluminum Oxide Ferric Oxide Yellow Silicon Dioxide Glycyrrhiza Glabra Aloe Vera Leaf Tocopherol Panthenol Magnesium Silicate Ferrosoferric Oxide Stearyl Triethoxysilane Magnesium Ascorbyl Phosphate Tetrahexyldecyl Ascorbate Retinyl Retinoate Cyclodextrins

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-07-30

Description

Drug Facts


Medication Information

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if rash occurs

Section 50567-7

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1

Do not use on damaged or broken skin

Section 55105-1
Active ingredient(s) Purpose
Titanium dioxide 2.6% Sunscreen
Zinc oxide 6.2% Sunscreen
Warnings

For external use only

Directions

For sunscreen use:

  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • children under 6 months: ask a doctor
  • 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 SPF 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-sleeve shirts, pants, hats, and sunglasses
Other Information

Protect this product from excessive heat and direct sun

Inactive Ingredients

cyclopentasiloxane, dimethicone crosspolymer, hydrogenated polydecene, dimethicone, styrene/acrylates copolymer, hexyl laurate, PEG-10 dimethicone, polyglyceryl-4 isostearate, stearic acid, alumina, silica, tocopherol, magnesium silicate, panthenol, glycyrrhiza glabra (licorice) root extract, aloe barbadensis leaf extract, stearyl triethoxysilane, tetrahexyldecyl ascorbate, magnesium ascorbyl phosphate, retinyl retinoate, cyclodextrin. may contain: titanium dioxide, iron oxides.

Questions Or Comments?

Call toll free 1-888-795-4747

Principal Display Panel 30 Ml Bottle Carton Light

bareMinerals ®

PRIME TIME™

BB PRIMER-CREAM

BROAD SPECTRUM SPF 30

30 ml / 1 fl. oz.

Principal Display Panel 30 Ml Bottle Carton Medium

bareMinerals ®

PRIME TIME™

BB PRIMER-CREAM

BROAD SPECTRUM SPF 30

30 ml / 1 fl. oz.


Structured Label Content

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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs

Section 50567-7 (50567-7)

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Section 55105-1 (55105-1)
Active ingredient(s) Purpose
Titanium dioxide 2.6% Sunscreen
Zinc oxide 6.2% Sunscreen
Warnings

For external use only

Directions

For sunscreen use:

  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • children under 6 months: ask a doctor
  • 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 SPF 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-sleeve shirts, pants, hats, and sunglasses
Other Information (Other information)

Protect this product from excessive heat and direct sun

Inactive Ingredients (Inactive ingredients)

cyclopentasiloxane, dimethicone crosspolymer, hydrogenated polydecene, dimethicone, styrene/acrylates copolymer, hexyl laurate, PEG-10 dimethicone, polyglyceryl-4 isostearate, stearic acid, alumina, silica, tocopherol, magnesium silicate, panthenol, glycyrrhiza glabra (licorice) root extract, aloe barbadensis leaf extract, stearyl triethoxysilane, tetrahexyldecyl ascorbate, magnesium ascorbyl phosphate, retinyl retinoate, cyclodextrin. may contain: titanium dioxide, iron oxides.

Questions Or Comments? (Questions or comments?)

Call toll free 1-888-795-4747

Principal Display Panel 30 Ml Bottle Carton Light (PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton - Light)

bareMinerals ®

PRIME TIME™

BB PRIMER-CREAM

BROAD SPECTRUM SPF 30

30 ml / 1 fl. oz.

Principal Display Panel 30 Ml Bottle Carton Medium (PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton - Medium)

bareMinerals ®

PRIME TIME™

BB PRIMER-CREAM

BROAD SPECTRUM SPF 30

30 ml / 1 fl. oz.


Advanced Ingredient Data


Raw Label Data

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