HEB SPF 50 REFINE 50 SUNSCREEN WITH NIACINAMIDE AND COLLAGEN CONTINUOUS SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene spray

HEB SPF 50 Refine 50 Sunscreen with Niacinamide and Collagen Continuous Sunscreen by

Drug Labeling and Warnings

HEB SPF 50 Refine 50 Sunscreen with Niacinamide and Collagen Continuous 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 4.0%

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

FLAMMABLE:

• do not use near heat, flame or while smoking
• avoid long term stoage 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. do not puncture or incinerate. Contents under pressure. do not store at temperatures above 120°F.

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
• hold can 4-6 inches away from body, spray evenly to ensure complete coverage
• do not spray into face. Spray into hand and apply to face.
• use in well ventilated, but not windy areas
• 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.

wearl 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

SD ALCOHOL 40-B, BUTYLOCTYL SALICYLATE, FRAGRANCE, ACRYLATES/OCTYLACRYLAMIDE COPOLYMER, ALOE BARBADENSIS LEAF JUICE, BUTYLENE GLYCOL, SACCHAROMYCES/ PODOPHYLLUM PELTATUM FERMENT FILTRATE, DAUCUS CAROTA SATIVA (CARROT) ROOT EXTRACT, PANTHENOL, PERSEA GRATISSIMA (AVOCADO) OIL, VITIS VINIFERA (GRAPE) SEED OIL, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, COCOS NUCIFERA (COCONUT) OIL, CAPRYLIC/CAPRIC TRIGLYCERIDE, GLYCERIN, STEAROXYTRIMETHYLSILANE, TOCOPHEROL, HYDROLYZED COLLAGEN, NIACINAMIDE.

Label

INGREDIENTS AND APPEARANCE

HEB SPF 50 REFINE 50 SUNSCREEN WITH NIACINAMIDE AND COLLAGEN CONTINUOUS SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37808-142
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 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BOVINE TYPE I COLLAGEN (UNII: FHJ3ATL51C)
PODOPHYLLUM (UNII: 2S713A4VP3)
WATER (UNII: 059QF0KO0R)
CARROT (UNII: L56Z1JK48B)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PANTHENOL (UNII: WV9CM0O67Z)
JOJOBA OIL (UNII: 724GKU717M)
ALCOHOL (UNII: 3K9958V90M)
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
GLYCERIN (UNII: PDC6A3C0OX)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
GRAPE SEED OIL (UNII: 930MLC8XGG)
COCONUT OIL (UNII: Q9L0O73W7L)
AVOCADO OIL (UNII: 6VNO72PFC1)
STEAROXYTRIMETHYLSILANE (UNII: 9862TW94B2)
NIACINAMIDE (UNII: 25X51I8RD4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37808-142-37	156 g in 1 CAN; Type 0: Not a Combination Product	01/27/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	01/27/2022

Labeler - H.E.B (007924756)