Boom Sun Spf 30

Boom Sun Spf 30
SPL v2
SPL
SPL Set ID e31523ac-16da-6e39-e053-2a95a90a98a2
Route
TOPICAL
Published
Effective Date 2022-07-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (3.75 mg)
Inactive Ingredients
Tocopherol Levomenol Helianthus Annuus Seed Wax Rosmarinus Officinalis Flowering Top Oil Squalane Argania Spinosa Seed Isopropyl Palmitate Coconut Alkanes Stearic Acid Coco-caprylate/caprate Heptyl Undecylenate Aluminum Oxide Oryza Sativa Whole Polyhydroxystearic Acid (2300 Mw) Alpha-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2022-07-05

Description

Titanium Dioxide 7.5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium Dioxide 7.5%

Section 50565-1

Keep out of the reach of children.

Warnings

Warnings When using this product

  • keep out of the eye area
  • rinse with water to remove
  • stop use and ask a doctor if rash or irritation develops
  • for external use onlyl
  • keep out of reach of children
Directions

Directions

Shake well before use

Using the bulb pipette, dispense 4-6 drops in the palm of the hand.

Rub hands together, then apply liberally and evenly to the face using a circular motion.

Allow 15 minutes after application before sun exposure.

Reapply every 2 hours and after swimming or sweating.

Children under 6 months of age: Ask a doctor.

Protect the product in this container from excessive heat.

Active Ingredients

Titanium Dioxide 7.5%

Inactive Ingredients

Inactive Ingredients:

Isopropyl Palmitate, Coconut Alkanes (and) Coco Caprylate/Caprate, Caprylic/Capric Triglyceride, Heptyl Undecylenate, Argania Spinosa Kernel Oil, Stearic Acid, *Squalane, Alumina, Oryza Sativa (Rice) Bran Extract, Polyhydroxystearic Acid, Bisabolol, Helianthus Annuus (Sunflower) Seed Oil, Rosmarinus Officinalis (Rosemary) Extract, Tocopherol, Tocopheryl Acetate (Vitamin E)

* From Sugarcane

Principal Display Panel


Structured Label Content

Section 50565-1 (50565-1)

Keep out of the reach of children.

Purpose

Sunscreen

Warnings

Warnings When using this product

  • keep out of the eye area
  • rinse with water to remove
  • stop use and ask a doctor if rash or irritation develops
  • for external use onlyl
  • keep out of reach of children
Directions

Directions

Shake well before use

Using the bulb pipette, dispense 4-6 drops in the palm of the hand.

Rub hands together, then apply liberally and evenly to the face using a circular motion.

Allow 15 minutes after application before sun exposure.

Reapply every 2 hours and after swimming or sweating.

Children under 6 months of age: Ask a doctor.

Protect the product in this container from excessive heat.

Active Ingredients

Titanium Dioxide 7.5%

Inactive Ingredients

Inactive Ingredients:

Isopropyl Palmitate, Coconut Alkanes (and) Coco Caprylate/Caprate, Caprylic/Capric Triglyceride, Heptyl Undecylenate, Argania Spinosa Kernel Oil, Stearic Acid, *Squalane, Alumina, Oryza Sativa (Rice) Bran Extract, Polyhydroxystearic Acid, Bisabolol, Helianthus Annuus (Sunflower) Seed Oil, Rosmarinus Officinalis (Rosemary) Extract, Tocopherol, Tocopheryl Acetate (Vitamin E)

* From Sugarcane

Principal Display Panel


Advanced Ingredient Data


Raw Label Data

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