Label: HAPPY FARM BOTANICALS PROTECTIVE DAY CREAM SPF 30- zinc oxide, titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 73964-030-01 - Packager: Happy Farm Botanicals, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated February 9, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients Section
- Purpose
- Uses
- Warnings
- Do Not Use
- When using this product
- Stop Use and ask a Doctor
- Keep out of reach of Children
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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
- Inactive Ingredients
- Principal Display Panel Front of Package
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HAPPY FARM BOTANICALS PROTECTIVE DAY CREAM SPF 30
zinc oxide, titanium dioxide creamProduct 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)
