SENSIBLE SPF 32 MINERAL SUNSCREEN- zinc oxide cream

SENSIBLE SPF 32 MINERAL SUNSCREEN by

Drug Labeling and Warnings

SENSIBLE SPF 32 MINERAL SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by Kindred Bravely, Kabana Skin Care. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Zinc Oxide 25%

Purpose

Sunscreen

INDICATIONS & USAGE

Uses:

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

Warnings

Warnings

For External Use Only

Do not use on damaged or broken skin

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

Stop use and ask doctor if rash appears

Keep out of reach of children. If

product is swallowed, get medical help

or contact Poison Control Center right

away.

DOSAGE & ADMINISTRATION

Directions

• Apply generously and evenly to all skin exposed to sun 15 minutes before sun exposure
• Children under 6 months of age: 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 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

Reapply after:

• 40 minutes of swimming or sweating
• Immediately after towel drying
• at least every 2 hours

OTHER SAFETY INFORMATION

Other Information: Protect this product from excessive heat and direct sun

QUESTIONS

Questions or comments? 888-850-3756 or Kindredbravely.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SENSIBLE SPF 32 MINERAL SUNSCREEN 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82751-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 60 (UNII: CAL22UVI4M)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
TOCOPHEROL (UNII: R0ZB2556P8)
SHEA BUTTER (UNII: K49155WL9Y)
JOJOBA OIL (UNII: 724GKU717M)
OLIVE OIL (UNII: 6UYK2W1W1E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82751-101-01	85 g in 1 TUBE; Type 0: Not a Combination Product	05/13/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/13/2022

Labeler - Kindred Bravely (085227654)

Establishment
Name	Address	ID/FEI	Business Operations
Kabana Skin Care		080237112	manufacture(82751-101)