Abc Arbonne Baby Care ®

Abc Arbonne Baby Care ®
SPL v2
SPL
SPL Set ID dab14650-50d2-4c56-ba7a-421f63dfe394
Route
TOPICAL
Published
Effective Date 2023-12-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (144 mg)
Inactive Ingredients
Water Alkyl (c12-15) Benzoate Medium-chain Triglycerides Coco-caprylate Polyglyceryl-2 Dipolyhydroxystearate Dicaprylyl Carbonate Polyglyceryl-4 Isostearate Cetyl Dimethicone 25 Glycerin Carnauba Wax Cetyl Alcohol Candelilla Wax Starch, Tapioca Calendula Officinalis Flower Chamomile Aloe Vera Leaf Triethoxycaprylylsilane .alpha.-tocopherol Acetate Magnesium Sulfate, Unspecified Form Sodium Chloride Silica Dimethyl Silylate Stearic Acid Chlorphenesin Phenoxyethanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2023-06-30 Until 2026-08-16

Description

Drug Facts

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

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

Section 50566-9

Stop use and ask a doctor ifrash occurs

Section 50567-7

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

Section 50570-1

Do not useon damaged or broken skin

Warnings

For external use only

Directions
  • apply liberally 15 minutes before sun exposure
  • reapply:
    • after 40 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
  • 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 value 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-sleeved shirts, pants, hats, and sunglasses
  • children under 6 months of age: ask a doctor
Active Ingredient

Zinc Oxide 14.4%

Other Information
  • protect the product in this container from excessive heat and direct sun
Inactive Ingredients

water, C12-15 alkyl benzoate, caprylic/capric triglyceride, coco-caprylate, polyglyceryl-2 dipolyhydroxystearate, dicaprylyl carbonate, polyglyceryl-4 isostearate, cetyl dimethicone, glycerin, copernicia cerifera (carnauba) wax, cetyl alcohol, euphorbia cerifera (candelilla) wax, tapioca starch, calendula officinalis flower extract, chamomilla recutita (matricaria) flower extract, aloe barbadensis leaf juice, triethoxycaprylylsilane, tocopheryl acetate, magnesium sulfate, sodium chloride, silica dimethyl silylate, stearic acid, chlorphenesin, phenoxyethanol.

Questions Or Comments?

1.800.272.6663

Monday–Friday 6 a.m.–6 p.m. Pacific time

Principal Display Panel 177 Ml Tube Carton

ABC

ARBONNE BABY CARE ®

SUNSCREEN

BROAD SPECTRUM SPF 30

WATER-RESISTANT

(40 Minutes)

6 fl. oz./177 mL


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

Section 50566-9 (50566-9)

Stop use and ask a doctor ifrash occurs

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)

Do not useon damaged or broken skin

Purpose

Sunscreen

Warnings

For external use only

Directions
  • apply liberally 15 minutes before sun exposure
  • reapply:
    • after 40 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
  • 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 value 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-sleeved shirts, pants, hats, and sunglasses
  • children under 6 months of age: ask a doctor
Active Ingredient (Active ingredient)

Zinc Oxide 14.4%

Other Information (Other information)
  • protect the product in this container from excessive heat and direct sun
Inactive Ingredients (Inactive ingredients)

water, C12-15 alkyl benzoate, caprylic/capric triglyceride, coco-caprylate, polyglyceryl-2 dipolyhydroxystearate, dicaprylyl carbonate, polyglyceryl-4 isostearate, cetyl dimethicone, glycerin, copernicia cerifera (carnauba) wax, cetyl alcohol, euphorbia cerifera (candelilla) wax, tapioca starch, calendula officinalis flower extract, chamomilla recutita (matricaria) flower extract, aloe barbadensis leaf juice, triethoxycaprylylsilane, tocopheryl acetate, magnesium sulfate, sodium chloride, silica dimethyl silylate, stearic acid, chlorphenesin, phenoxyethanol.

Questions Or Comments? (Questions or comments?)

1.800.272.6663

Monday–Friday 6 a.m.–6 p.m. Pacific time

Principal Display Panel 177 Ml Tube Carton (PRINCIPAL DISPLAY PANEL - 177 mL Tube Carton)

ABC

ARBONNE BABY CARE ®

SUNSCREEN

BROAD SPECTRUM SPF 30

WATER-RESISTANT

(40 Minutes)

6 fl. oz./177 mL


Advanced Ingredient Data


Raw Label Data

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