HILL COUNTRY ESSENTIALS- spf 15 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

Octinoxate 7.5%, Octisalate 5.0%, Oxybenzone 3.0%

Purpose

Sunscreen

Uses

• helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

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

    pump onto hands and apply liberally and evenly to face and neck 15 minutes before sun exposure
    use daily after cleansing
    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 Ingredient(s)

water, octyldodecyl neopentanoate, glycerin, emulsifying wax NF, glyceryl stearate, PEG-100 stearate, dimethicone, triethanolamine, diazolidinyl urea, methylparaben, ethylparaben, propylparaben, carbomer

Questions or Comments?

Call toll free 1-800-527-7731

PRINCIPAL DISPLAY PANEL

HILL COUNTRY ESSENTIALS OIL FREE FACIAL MOISTURIZER SPF 15

4 FL OZ (118mL)

NDC: 37808-925-04

INGREDIENTS AND APPEARANCE

HILL COUNTRY ESSENTIALS 
spf 15 lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37808-925
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
GLYCERIN (UNII: PDC6A3C0OX)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYSORBATE 60 (UNII: CAL22UVI4M)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
DIMETHICONE (UNII: 92RU3N3Y1O)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37808-925-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/04/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/04/2018

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(37808-925)