OTC Medication Information: H.E.B SOLUTIONS SUNSCREEN

H.E.B SOLUTIONS SUNSCREEN- avobenzone, homosalate, octisalate and octocrylene stick
H.E.B

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.

Active Ingredients

Avobenzone 3.0%, Homosalate 15.0%, Octisalate 5.0%, Octocrylene 10.0%

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  • on damaged or broken skin.

When using this product • keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if  • rash occurs.

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 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

Other Information

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

Inactive Ingredient(s)

beeswax, ozokertie, cetearyl behenate, lauryl lactate, polybutene, butyloctyl salicylate, cetyl alcohol, myristyl myristate, styrene/acrylates copolymer, theobroma cacao (cocoa) seed butter, phenoxyethanol, tetrahexyldecyl ascorbate (vitamin C ester), tocopherol (vitamin E).

Questions or Comments?

Call toll free 1-800-527-7731

H-E-B SOLUTIONS SUNSCREEN SPF 55 UNSCENTED KIDS SUNSCREEN STICK

1.5 OZ (42g)

NDC 37808-926-28

LabelFront
(click image for full-size original)
LabelBack1
(click image for full-size original)
LabelBack2
(click image for full-size original)
LabelBack3
(click image for full-size original)

H.E.B SOLUTIONS SUNSCREEN
spf 55 stick
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:37808-926
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE (AVOBENZONE) AVOBENZONE 30 mg in 1 g
HOMOSALATE (HOMOSALATE) HOMOSALATE 150 mg in 1 g
OCTISALATE (OCTISALATE) OCTISALATE 50 mg in 1 g
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 100 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S)
YELLOW WAX
TOCOPHEROL
BUTYLOCTYL SALICYLATE
CETYL ALCOHOL
MYRISTYL MYRISTATE
COCOA BUTTER
PHENOXYETHANOL
TETRAHEXYLDECYL ASCORBATE
CERESIN
CETEARYL BEHENATE
LAURYL LACTATE
POLYBUTENE (1400 MW)
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:37808-926-28 42 g in 1 CONTAINER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 04/05/2019
Labeler — H.E.B (007924756)
Registrant — Fruit of the Earth, Inc. (079559467)
Establishment
Name Address ID/FEI Operations
Fruit of the Earth, Inc. 008193513 manufacture (37808-926)

Revised: 03/2020 H.E.B

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2021. All Rights Reserved.