HAPPY FARM BOTANICALS PROTECTIVE DAY CREAM SPF 30- zinc oxide, titanium dioxide cream

Happy Farm Botanicals Protective Day Cream SPF 30 by

Drug Labeling and Warnings

Happy Farm Botanicals Protective Day Cream SPF 30 by is a Otc medication manufactured, distributed, or labeled by Happy Farm Botanicals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients Section

Active Ingredients

Non-Nano Uncoated Zinc Oxide, 2.34%

Titanium Dioxide, 3.60%

Purpose

Sunscreen

Uses

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.

Warnings

Warnings

For external use only

Do not use on damage or broken skin.

Do Not Use

Do not use on damage or broken skin

When using this product

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

Stop Use and ask a Doctor

Stop use and ask a doctor if rash occurs.

Keep out of reach of Children

Keep out of reach of Children. If product is swallowed get medical help or contact a poison control center right away.

Directions

• Shake well
• 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 of 15 or higher and other sun protection measures including:
• Limit time in the sun, especially from 10:00 am – 2:00 pm.\
• Wear long-sleeve shirts, pants, hats, and sunglasses.
• Children under 6 months: Ask a doctor

Other Information

Other Information

• Protect this product from excessive heat and direct sun.

Inactive Ingredients

Inactive Ingredients

Water, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Caprylic/Capric Triglycerides, Pentylene Glycol, Sorbitan Oleate Decylglucoside Crosspolymer, Glycerin, Ethyl Lauroyl Arginate HCl, VP/Eicosene Copolymer, Glyceryl Strearate.

Principal Display Panel Front of Package

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HAPPY FARM BOTANICALS PROTECTIVE DAY CREAM SPF 30 
zinc oxide, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73964-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2.34 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)	1 g  in 100 g
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)	4 g  in 100 g
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)	4 g  in 100 g
EICOSYL POVIDONE (2 EICOSYL BRANCHES/REPEAT) (UNII: XQQ9MKE2BJ)	2 g  in 100 g
PENTYLENE GLYCOL (UNII: 50C1307PZG)	4 g  in 100 g
C12-15 ALKYL ETHYLHEXANOATE (UNII: GQJ580CH83)	5 g  in 100 g
WATER (UNII: 059QF0KO0R)	65.06 g  in 100 g
SORBETH-12/OLEATE/DIMER DILINOLEATE CROSSPOLYMER (UNII: 6287108Q5R)	4 g  in 100 g
XANTHAN GUM (UNII: TTV12P4NEE)	1 g  in 100 g
ETHYL LAUROYL ARGINATE HYDROCHLORIDE (UNII: XPD6ZY79TB)	2 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX)	2 g  in 100 g

Product Characteristics
Color	white (Cream)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73964-030-01	236 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/04/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/04/2022

Labeler - Happy Farm Botanicals, Inc. (022653140)

Registrant - Happy Farm Botanicals, Inc. (022653140)

Establishment
Name	Address	ID/FEI	Business Operations
Happy Farm Botanicals, Inc.		022653140	manufacture(73964-030)