Drugplain

H.E.B 30 mg/g

SPF 50 Sunscreen · AEROSOL, SPRAY · H.E.B

9 Recalls on Record
Plain English

This is an over-the-counter sunscreen spray with SPF 50 that you apply to your skin to protect against sunburn and sun damage. It comes in an aerosol spray form for convenient topical application.

Key Facts

Brand Name
H.E.B
Generic Name
SPF 50 Sunscreen
NDC Code (Product)
37808-997
Manufacturer
H.E.B
Strength
30 mg/g
Dosage Form
AEROSOL, SPRAY
Route
TOPICAL
Marketing Status
Application #
M020
Marketing Start
04/26/2019

Recall History

9 Recalls on Record
Class II06/13/2023

K.C. Pharmaceuticals, Inc

CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.

OngoingVoluntary: Firm initiated
Class II10/23/2019

Perrigo Company PLC

CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.

TerminatedVoluntary: Firm initiated
Class II03/03/2026

K.C. Pharmaceuticals, Inc

Lack of Assurance of Sterility

OngoingVoluntary: Firm initiated
Class II07/27/2021

Perrigo Company PLC

Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.

TerminatedVoluntary: Firm initiated
Class II07/27/2021

Perrigo Company PLC

Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.

TerminatedVoluntary: Firm initiated
Class II01/08/2016

Perrigo Company PLC

Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorrect dose markings on the dosing cups.

TerminatedVoluntary: Firm initiated
Class II03/03/2026

K.C. Pharmaceuticals, Inc

Lack of Assurance of Sterility

OngoingVoluntary: Firm initiated
Class II10/23/2019

Perrigo Company PLC

CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.

TerminatedVoluntary: Firm initiated
Class II05/28/2026

Guardian Drug Co. Inc.

Presence of foreign substance: small metallic particles in chewable tablets.

OngoingVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

vomiting199 reports
pruritus196 reports
condition aggravated182 reports
headache180 reports
weight decreased173 reports
drug ineffective172 reports
infection172 reports
hypertension171 reports
urticaria168 reports
weight increased167 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

Dosage & Administration

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 SPF 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.

Warnings

Warnings For external use only

Frequently Asked Questions

What is H.E.B used for?

This is an over-the-counter sunscreen spray with SPF 50 that you apply to your skin to protect against sunburn and sun damage. It comes in an aerosol spray form for convenient topical application.

Is H.E.B a controlled substance?

H.E.B is not classified as a controlled substance by the DEA.

What is the generic name for H.E.B?

The generic name for H.E.B is SPF 50 Sunscreen. There are 8 other brand versions of SPF 50 Sunscreen.

What is the NDC code for H.E.B 30 mg/g?

The NDC (National Drug Code) for H.E.B 30 mg/g is 37808-997, listed by H.E.B.