FARMHOUSE FRESH ELEVATED SHADE SPF 30- zinc oxide cream

FARMHOUSE FRESH ELEVATED SHADE by

Drug Labeling and Warnings

FARMHOUSE FRESH ELEVATED SHADE by is a Otc medication manufactured, distributed, or labeled by SUMMER SOLES LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Zinc Oxide 21.50%

PURPOSE

SUNSCREEN

Uses

• Helps protect against sunburn
• provides moderate protection against sunburn

Warnings

• 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 occurs

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children If swallowed, get medicl help or contact poison control center.

Directions

Apply generously and evenly 15 minutes before sun exposure.
Children under 6 months of age: ask doctor.
Sun protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the 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 10a.m. - 2p.m.
• wear long sleeve shirts, pants, hats and sunglasses.

Reapply at least every 2 hours
Use a water-resistant sunscreen if swimming or sweating

Other Information

Protect the product in this contianer from heat and direct sun.

INACTIVE INGREDIENTS

Water/Eau, Caprylic/Capric Triglyceride, Ethyl Macadamiate, Glycerin, Propanediol, Polyglyceryl-3 Polyricinoleate, Triethoxycaprylylsilane, Polyglyceryl-10 Stearate, Cetearyl Olivate, Xanthan Gum, Magnesium Aluminum Silicate, Sodium Hyaluronate, Sodium PCA, Niacinamide, Allantoin, Quercetin, Sodium Ascorbyl Phosphate, Camellia Sinensis Leaf Extract, Sodium Chloride, Glyceryl Isostearate, Polyhydroxystearic, Sorbital Olivate, Linum Usitatissmum (flax) seed oil, Tocopherol, Iron Oxides, Triethoxysilylpropyl Acetyl Hydroxyprolinate, Phenoxyethanol, Caprylyl Glycol, Polymethyl Methacrylate, Tromethamine, Pisum sativum (Dwarf Gray Sugar Pea) Extract, Parfum* *Natural fragrance derived from 100% natural sources.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FARMHOUSE FRESH ELEVATED SHADE  SPF 30
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72788-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	21 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ETHYL MACADAMIATE (UNII: ANA2NCS6V1)
GLYCERIN (UNII: PDC6A3C0OX)
PROPANEDIOL (UNII: 5965N8W85T)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POLYGLYCERYL-10 STEARATE (UNII: 90TF85HH91)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
XANTHAN GUM (UNII: TTV12P4NEE)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
NIACINAMIDE (UNII: 25X51I8RD4)
ALLANTOIN (UNII: 344S277G0Z)
QUERCETIN (UNII: 9IKM0I5T1E)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
SORBITAN OLIVATE (UNII: MDL271E3GR)
FLAX SEED (UNII: 4110YT348C)
TOCOPHEROL (UNII: R0ZB2556P8)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TRIETHOXYSILYLPROPYL STEARDIMONIUM (UNII: 2606S334CS)
OXACEPROL (UNII: Q0XV76B96L)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
TROMETHAMINE (UNII: 023C2WHX2V)
PISUM SATIVUM WHOLE (UNII: J21YE3W98E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72788-101-12	1 in 1 CARTON	04/04/2020
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/04/2020

Labeler - SUMMER SOLES LLC (780418674)