HEB SOLUTIONS SUNSCREEN FACE 50 FACIAL MIST SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene spray

HEB Solutions Sunscreen Face 50 Facial Mist Sunscreen by

Drug Labeling and Warnings

HEB Solutions Sunscreen Face 50 Facial Mist Sunscreen 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 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 2.5%

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

FLAMMABLE:

    do not use near heat, flame or while smoking

    avoid long term storage above 104°F (40°C)

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

• shake bottle vigorously before each use.
• apply liberally and evenly 15 minutes before sun exposure.
• hold bottle 6-8 inches away from face, pull hair back, close eyes, tuck lips, then spray at least 7-10 times in a circle to ensure complete coverage. Keep eyes closed for about 3 seconds after application.
• 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
• may temporarily sting

Inactive ingredients

acrylates/octylacrylamide copolymer, aloe barbadensis leaf juice, butyloctyl salicylate, caprylic/capric triglyceride, fragrance, glycerin, isododecane, panthenol, SD alcohol 40-B, silica silylate, tocopherol.

Label

INGREDIENTS AND APPEARANCE

HEB SOLUTIONS SUNSCREEN FACE 50 FACIAL MIST SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37808-127
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	25 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
GLYCERIN (UNII: PDC6A3C0OX)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
PANTHENOL (UNII: WV9CM0O67Z)
ISODODECANE (UNII: A8289P68Y2)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37808-127-04	118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/02/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	03/02/2020

Labeler - H.E.B (007924756)