WHIPPED BUTTER SPF 50- zinc oxide cream

Whipped Butter SPF 50 by

Drug Labeling and Warnings

Whipped Butter SPF 50 by is a Otc medication manufactured, distributed, or labeled by Bloom effects, Inc, Inspec Solutions, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Zinc Oxide 14.70%

PURPOSE

Sunscreen

INDICATIONS & USAGE

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

WARNINGS

For external use only.

DO NOT USE

Do not use on damaged or broken skin.

WHEN USING

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

STOP USE

Stop use & ask a doctor if skin rash occurs.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

• Apply liberally 15 minutes before sun exposure
• Reapply: after 80 minutes of swimming 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 & other sun protection measures including:

• limit your 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.

OTHER SAFETY INFORMATION

Protect the product in this container from excessive heat and direct sun.

INACTIVE INGREDIENT

Octyldodecanol

Caprylic/Capric Triglyceride

Butyloctyl Salicylate

Ethylhexyl Methoxycrylene

C12-15 Alkyl Benzoate

VP/Hexadecane Coplymer

Dibutyl Lauroyl Glutamide

Butrospermum Parkii (Shea) Oil

Rebaudioside-A

Simmondsia Chinensis (Jojoba) Seed Oil

Sodium Hyaluronate

Tetrahexyldecyl Ascorbate

Tocopheryl Acetate

Tulipa Gesneriana Flower Extract

Vitis Vinifera (Grape) Seed Oil

Triethoxycaprylylsilane

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

WHIPPED BUTTER SPF 50 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82548-2421
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	14.7 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL (UNII: 724GKU717M)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
REBAUDIOSIDE A (UNII: B3FUD0528F)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
TULIPA GESNERIANA WHOLE (UNII: HYG96DA49A)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
OCTYLDODECANOL (UNII: 461N1O614Y)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
VP/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
DIBUTYL LAUROYL GLUTAMIDE (UNII: 3V7K3IA58X)
VITIS VINIFERA (GRAPE) SEED OIL (UNII: 930MLC8XGG)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82548-2421-1	100 g in 1 JAR; Type 0: Not a Combination Product	06/11/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	06/11/2025

Labeler - Bloom effects, Inc (096991853)

Registrant - Inspec Solutions, LLC (081030372)

Establishment
Name	Address	ID/FEI	Business Operations
Inspec Solutions, LLC		081030372	manufacture(82548-2421)