H.E.B SOLUTIONS SUNSCREEN- ultra spf 50 lotion lotion

H.E.B by

Drug Labeling and Warnings

H.E.B 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

Acobenzone 2.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 7.0%, Oxybenzone 6.0%

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 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
• reapply:

    after 80 minutes of swimming or sweating

    immediately after towel drying

    at least every 2 hours

• children under 6 months of age: ask a doctor
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early 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 10am-2pm

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

Other Information

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

Inactive Ingredient(s)

water, propylene glycol, silica, aluminum starch octenylsuccinate, behenyl alcohol, butylated PVP, glyceryl stearate, microcrystalline cellulose, benzyl alcohol, palmitic acid, myristyl alcohol, stearic acid, saccharomyces/podophyllum peltatum ferment filtrate, lauryl alcohol, cetyl alcohol, aloe barbadensis leaf juice, chamomilla recutita (matricaria) flower extract, tocopherol (vitamin E), lecithin, cellulose gum, chlorphenesin, disodium EDTA, butylene glycol

Questions or Comments?

Call toll free 1-800-527-7731

PRINCIPAL DISPLAY PANEL

H.E.B Solutions Sunscreen Ultra SPF 50 Lotion

3 FL OZ (89mL)

NDC: 37808-956-09

H.E.B Solutions Sunscreen Ultra SPF 50 Lotion

8 FL OZ (237mL)

NDC: 37808-956-12

INGREDIENTS AND APPEARANCE

H.E.B  SOLUTIONS SUNSCREEN
ultra spf 50 lotion lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37808-956
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	20 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	70 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	60 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
DOCOSANOL (UNII: 9G1OE216XY)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
BENZYL ALCOHOL (UNII: LKG8494WBH)
PALMITIC ACID (UNII: 2V16EO95H1)
MYRISTYL ALCOHOL (UNII: V42034O9PU)
STEARIC ACID (UNII: 4ELV7Z65AP)
LAURYL ALCOHOL (UNII: 178A96NLP2)
CETYL ALCOHOL (UNII: 936JST6JCN)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CHAMOMILE (UNII: FGL3685T2X)
TOCOPHEROL (UNII: R0ZB2556P8)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
CHLORPHENESIN (UNII: I670DAL4SZ)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37808-956-09	89 mL in 1 TUBE; Type 0: Not a Combination Product	02/20/2012
2	NDC: 37808-956-12	237 mL in 1 TUBE; Type 0: Not a Combination Product	02/20/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/20/2012

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(37808-956)