KROGER INVISIBLE SUNSCREEN SPF 40- avobenzone, homosalate, octisalate, octocrylene gel

Kroger Invisible Sunscreen SPF 40 by

Drug Labeling and Warnings

Kroger Invisible Sunscreen SPF 40 by is a Otc medication manufactured, distributed, or labeled by THE KROGER COMPANY. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3.0%, Homosalate 11.0%, Octisalate 5.0%, Octocrylene 10.0%

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 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

aloe barbadensis leaf extract, Bis-vinyldimethicone/peg-10 dimethicone crosspolymer, butyloctyl salicylate, butyrospermum parkii (shea) butter, cetyl peg/ppg-10/1 dimethicone, citrus aurantium dulcis (orange) oil, dimethicone, dimethicone crosspolymer, dimethicone/vinyl dimethicone crosspolymer, disteardimonium hectorite, hexyl laurate, hydrated silica, isododecane, isohexadecane, lecithine, mineral oil, neopentyl glycol diethylhexanoate, phenoxyethanol, polyester-8, polyglyceryl-4 isostearate, polymethyl methacrylate, polymethylsilsequioxane, tocopherol

Label

INGREDIENTS AND APPEARANCE

KROGER INVISIBLE SUNSCREEN SPF 40 
avobenzone, homosalate, octisalate, octocrylene gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 30142-239
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	110 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ISOHEXADECANE (UNII: 918X1OUF1E)
MINERAL OIL (UNII: T5L8T28FGP)
ORANGE OIL (UNII: AKN3KSD11B)
DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER (UNII: RSA9I561OK)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SHEA BUTTER (UNII: K49155WL9Y)
ISODODECANE (UNII: A8289P68Y2)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 30142-239-09	89 mL in 1 TUBE; Type 0: Not a Combination Product	09/27/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/27/2019

Labeler - THE KROGER COMPANY (006999528)