HEB SPF 50 BIRTHDAY CAKE SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene lotion

HEB SPF 50 Birthday Cake Sunscreen by

Drug Labeling and Warnings

HEB SPF 50 Birthday Cake 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 4.5%, Octocrylene 8.0%

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

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 Ingredient(s)

water, polyester-7, neopentyl glycol diheptanoate, glycerin, cetearyl olivate, styrene/acrylates copolymer, sorbitan olivate, aluminum starch octenylsuccinate, olive oil polyglyceryl-6 esters, saccharomyces/podophyllum peltatum ferment filtrate, butylene glycol, silica, phenoxyethanol, isododecane, sodium stearoyl lactylate, cetearyl alcohol, cetyl palmitate, sorbitan palmitate, ethylhexylglycerin, acrylates/C10-30 alkyl acrylate crosspolymer, tocopherol (vitamin E), potassium hydroxide, sodium ascorbyl phosphate, fragrance.

Label

INGREDIENTS AND APPEARANCE

HEB SPF 50 BIRTHDAY CAKE SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37808-074
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	45 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	80 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
POLYESTER-7 (UNII: 0841698D2F)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
ISODODECANE (UNII: A8289P68Y2)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PODOPHYLLUM (UNII: 2S713A4VP3)
SORBITAN OLIVATE (UNII: MDL271E3GR)
OLIVE OIL POLYGLYCERYL-6 ESTERS (UNII: 4KDO9AFM9I)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)
SORBITAN MONOPALMITATE (UNII: 77K6Z421KU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37808-074-12	237 mL in 1 TUBE; Type 0: Not a Combination Product	03/22/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/22/2021

Labeler - H.E.B (007924756)