KROGER SPORT SPF 50 SUNSTICK- avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone stick
Kroger

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient

Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone

Purpose

Sunscreen, Sunscreen, Sunscreen, Sunscreen, Sunscreen, Sunscreen,

Keep Out of Reach of Children

If product is swallowed, get medical help or contact a Poison Control Center right away.

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.

Directions

Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating. immediately after towel drying. at least every two hours. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad spectrum SPF 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-sleeve shirts, pants, hats and sunglasses. Children under 6 months of age; Ask a doctor.

Inactive Ingredients

BHT, C 12- 15 Alkyl Benzoat, Caprylic/Capric Triglyceride, Ceresin, Flavor, Methylparaben, Propylparaben, PVP/Hexadecene Copolymer, Synthetic Beeswax, Tocopherol, Zinc Oxide.

Package/Label Principal Display Panel

Kroger Sport SPF 50 Front of Card Kroger Sport SPF 50 - Back of Card

KROGER SPORT SPF 50 SUNSTICK
avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:30142-933
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3.00 mg in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	15 mg in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 mg in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5.00 mg in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 mg in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4.00 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
CERESIN (UNII: Q1LS2UJO3A)	15.00 mg in 1 g
WHITE WAX (UNII: 7G1J5DA97F)	14.5 mg in 1 g
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)	10.00 mg in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z)	6.00 mg in 1 g
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)	5.00 mg in 1 g

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:30142-933-04	1 g in 1 CONTAINER

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	04/29/2013

Labeler - Kroger (006999528)

Registrant - OraLabs (801824756)

Name	Address	ID/FEI	Business Operations
Establishment
OraLabs		801824756	MANUFACTURE(30142-933) , LABEL(30142-933)