HILL COUNTRY ESSENTIALS- spf 15 moisturizing lotion

Hill Country Essentials by

Drug Labeling and Warnings

Hill Country Essentials by is a Otc medication manufactured, distributed, or labeled by H.E.B, Fruit of the Earth, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3.0%, Octisalate 2.0%, Octinoxate 7.5%

Purpose

Sunscreen

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

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. 

ASK DOCTOR

Stop use and ask a doctor if  rash occurs.

KEEP OUT OF REACH OF CHILDREN

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

Directions

• apply liberally 15 minutes before sun exposure
• use a water resistant sunscreen if swimming or sweating
• reapply 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 of 15 or higher and other sun protection measures including:

    limit time in the sun, especially from 10 a.m. - 2 p.m.

    wear long-sleeve shirts, pants, hats, and sunglasses

• children under 6 months of age: ask a doctor

Other information

• protect this product from excessive heat and direct sun
• may stain or damage some fabrics, materials or surfaces

Inactive ingredients

water, C12-C15 alkyl benzoate, glycerin, cetearyl alcohol, dimethicone, glycine soja (soybean) seed extract, bis-phenylpropyl dimethicone, arachidyl alcohol, phenoxyethanol, cetearyl glucoside, panthenol, benzyl alcohol, ethylene/acrylic acid copolymer, behenyl alcohol, steareth-2, fragrance, steareth-21, polyacrylamide, polymethyl methacrylate, arachidyl glucoside, disodium EDTA, methylparaben, C13-14 isoparaffin, ethylparaben, butylparaben, laureth-7, benzalkonium chloride, propylparaben, isobutylparaben, iodopropynyl butylcarbamate, BHT, PEG-4 dilaurate, PEG-4 laurate, PEG-4, mica, silica, titanium dioxide

Questions or comments?

Call toll free 1-800-527-7731

PRINCIPAL DISPLAY PANEL

Hill Country Essentials Radiant Skin SPF 15 Moisturizing Lotion

4 FL OZ (120mL)

NDC: 37808-985-04

INGREDIENTS AND APPEARANCE

HILL COUNTRY ESSENTIALS 
spf 15 moisturizing lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37808-985
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	20 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PANTHENOL (UNII: WV9CM0O67Z)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLPARABEN (UNII: 14255EXE39)
METHYLPARABEN (UNII: A2I8C7HI9T)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
STEARETH-2 (UNII: V56DFE46J5)
STEARETH-21 (UNII: 53J3F32P58)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
DOCOSANOL (UNII: 9G1OE216XY)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
MICA (UNII: V8A1AW0880)
TRISILOXANE (UNII: 9G1ZW13R0G)
BIS-PHENYLPROPYL DIMETHICONE (15 CST) (UNII: 4836494CFT)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S) (UNII: 1PEZ3NLY6I)
LAURETH-7 (UNII: Z95S6G8201)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
PEG-4 DILAURATE (UNII: KCR71CW036)
PEG-4 LAURATE (UNII: AYF4VM3N1Z)
POLYETHYLENE GLYCOL 200 (UNII: R95B8J264J)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SOYBEAN OIL (UNII: 241ATL177A)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37808-985-05	1 in 1 CARTON	07/09/2011
1	NDC: 37808-985-04	120 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/09/2011

Labeler - H.E.B (007924756)

Registrant - Fruit of the Earth, Inc. (079559467)

Establishment
Name	Address	ID/FEI	Business Operations
Fruit of the Earth, Inc.		008193513	manufacture(37808-985)