H.E.B BABY: Package Insert and Label Information

H.E.B BABY- avobenzone, homosalate, octisalate and octocrylene aerosol, spray
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 10.0%, Octisalate 4.5%, Octocrylene 8.0%

Purpose

Sunscreen

Uses

  • helps prevent sunburn
  • if used as directed with other sun protetion 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)

water, butyloctyl salicylate, butylene glycol, glyceryl stearate, microcrystalline cellulose, behenyl alcohol, butylated PVP, stearic acid, lauryl alcohol, myristyl alcohol, cetyl alcohol, caprylic/capric triglyceride, tocopherol, sodium ascorbyl phosphate, cellulose gum, disodium EDTA, benzoic acid, benzoic alcohol, sorbic acid.

Questions or Comments?

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H-E-B SOLUTIONS SUNSCREEN BABY SPF 50 LOTION

8 FL OZ (237mL)

NDC 37808-913-12

Label
(click image for full-size original)
H.E.B BABY
spf 50 sunscreen aerosol, spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:37808-913
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE (AVOBENZONE) AVOBENZONE 30 mg in 1 mL
HOMOSALATE (HOMOSALATE) HOMOSALATE 100 mg in 1 mL
OCTISALATE (OCTISALATE) OCTISALATE 45 mg in 1 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 80 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
DOCOSANOL
GLYCERYL MONOSTEARATE
MICROCRYSTALLINE CELLULOSE
MYRISTYL ALCOHOL
STEARIC ACID
SORBIC ACID
LAURYL ALCOHOL
CETYL ALCOHOL
SODIUM ASCORBYL PHOSPHATE
BENZOIC ACID
TOCOPHEROL
MEDIUM-CHAIN TRIGLYCERIDES
CARBOXYMETHYLCELLULOSE SODIUM
BUTYLOCTYL SALICYLATE
EDETATE DISODIUM
BUTYLENE GLYCOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:37808-913-12 237 mL in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 02/05/2019
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 (37808-913)

Revised: 03/2020 H.E.B

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