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NDC 37808-0338-66 HEB Mineral Sunscreen SPF 50 216 mg/mL Details

HEB Mineral Sunscreen SPF 50 216 mg/mL

HEB Mineral Sunscreen SPF 50 is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by H.E.B.. The primary component is ZINC OXIDE.

Product Information

NDC	37808-0338
Product ID	37808-338_de9933f3-ee77-4fec-e053-2995a90a483f
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	HEB Mineral Sunscreen SPF 50
Proprietary Name Suffix	n/a
Non-Proprietary Name	Zinc Oxide
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	216
Active Ingredient Units	mg/mL
Substance Name	ZINC OXIDE
Labeler Name	H.E.B.
Pharmaceutical Class	Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2024-12-31

Package

Package Images

NDC 37808-0338-66 (37808033866)

Pricing Information	N/A
NDC Package Code	37808-338-66
Billing NDC	37808033866
Package	100 mL in 1 TUBE (37808-338-66)
Marketing Start Date	2020-03-04
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL de99343b-c74c-3f43-e053-2995a90ac9dd Details

Active ingredients

Zinc Oxide 21.6%

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 value 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-sleeved shirts, pants, hats, and sunglasses

Other information

• protect the product in this container from excessive heat and direct sun

• may stain or damage some fabrics, materials or surfaces

Inactive ingredients

water, C12-15 alkyl benzoate, caprylic/capric triglyceride, styrene/acrylates copolymer, octyldodecyl citrate crosspolymer, phenyl trimethicone, cetyl PEG/PPG-10/1 dimethicone, dimethicone, glycerin, polyhydroxystearic acid, ethyl methicone, cetyl dimethicone, silica, chrysanthemum parthenium (feverfew) flower/leaf/stem juice, glyceryl behenate, phenethyl alcohol, caprylyl glycol, bis-divinyl dimethicone PEG-10 dimethicone crosspolymer, sodium chloride, ethylhexylglycerin, fragrance

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HEB MINERAL SUNSCREEN SPF 50

zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37808-338
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	216 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: X323T6QO4M)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
GLYCERIN (UNII: PDC6A3C0OX)
ETHYL METHICONE (8 MPA.S) (UNII: 3YWG8XYT8H)
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCERYL MONOBEHENATE (UNII: A626UU0W2A)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
TANACETUM PARTHENIUM FLOWER (UNII: 7TVV9D7I89)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:37808-338-66	100 mL in 1 TUBE; Type 0: Not a Combination Product	03/04/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	03/04/2020

Labeler - H.E.B. (007924756)

Revised: 5/2022

Document Id: de9933f3-ee77-4fec-e053-2995a90a483f

Set id: de99343b-c74c-3f43-e053-2995a90ac9dd

Version: 1

Effective Time: 20220509