HEB OIL FREE FACIAL MOISTURIZER WITH SUNSCREEN BROAD SPECTRUM SPF 15- avobenzone, octisalate, octocrylene lotion

HEB Oil Free Facial Moisturizer with Sunscreen Broad Spectrum SPF 15 by

Drug Labeling and Warnings

HEB Oil Free Facial Moisturizer with Sunscreen Broad Spectrum SPF 15 by is a Otc medication manufactured, distributed, or labeled by H.E.B. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 1.5%, Octisalate 5.0%, Octocrylene 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

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
• use a water resistant sunscreen if swimming or sweating
• reapply 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, octyldodecyl neopentanoate, glycerin, cetearyl alcohol, polysorbate 60, butyloctyl salicylate, glyceryl stearate, PEG-100 stearate, dimethicone, phenoxyethanol, ethylhexylglycerin, caprylyl glycol, carbomer, sodium hydroxide, disodium EDTA, ethylene brassylate, dipropylene glycol, dimethyl heptenal

Label

INGREDIENTS AND APPEARANCE

HEB OIL FREE FACIAL MOISTURIZER WITH SUNSCREEN BROAD SPECTRUM SPF 15 
avobenzone, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37808-129
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	15 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	60 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
PEG-100 STEARATE (UNII: YD01N1999R)
HEXAMETHYLDISILOXANE (UNII: D7M4659BPU)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
POLYSORBATE 60 (UNII: CAL22UVI4M)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
2,6-DIMETHYL-5-HEPTENAL (UNII: Z331YX9EL9)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERYL 1-STEARATE (UNII: 258491E1RZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37808-129-04	1 in 1 CARTON	02/26/2021
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	02/26/2021

Labeler - H.E.B (007924756)