HAPPY FARM BOTANICALS PROTECTIVE DAY CREAM SPF 30- zinc oxide, titanium dioxide cream 
Happy Farm Botanicals, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Sunscreen Product Listing

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


Other Information

Other Information


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

PROTECTIVE DAY CREAM SUNSCREEN SPF 30LABEL PROTECTIVE DAY CREAM MINERAL SUNSCREEN SPF 30

HAPPY FARM BOTANICALS PROTECTIVE DAY CREAM SPF 30 
zinc oxide, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73964-030
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2.34 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.6 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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
Colorwhite (Cream) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73964-030-01236 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/04/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/04/2022
Labeler - Happy Farm Botanicals, Inc. (022653140)
Registrant - Happy Farm Botanicals, Inc. (022653140)
Establishment
NameAddressID/FEIBusiness Operations
Happy Farm Botanicals, Inc.022653140manufacture(73964-030)

Revised: 2/2022
Document Id: dbebb4a3-d74a-21ca-e053-2a95a90ae2f7
Set id: dbebb4d2-db6e-e6f6-e053-2a95a90ae6e1
Version: 1
Effective Time: 20220209
 
Happy Farm Botanicals, Inc.