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NDC 30142-0690-13 Kroger Sheer dry-touch SFP 30 3; 8; 5; 4; 4 g/100g; g/100g; g/100g; g/100g; g/100g Details

Kroger Sheer dry-touch SFP 30 3; 8; 5; 4; 4 g/100g; g/100g; g/100g; g/100g; g/100g

Kroger Sheer dry-touch SFP 30 is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Krogers. The primary component is AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE.

Product Information

NDC	30142-0690
Product ID	30142-690_5023f272-34b2-4cfe-a049-128285349612
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Kroger Sheer dry-touch SFP 30
Proprietary Name Suffix	n/a
Non-Proprietary Name	Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	3; 8; 5; 4; 4
Active Ingredient Units	g/100g; g/100g; g/100g; g/100g; g/100g
Substance Name	AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Labeler Name	Krogers
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2024-12-31

Package

Package Images

NDC 30142-0690-13 (30142069013)

Pricing Information	N/A
NDC Package Code	30142-690-13
Billing NDC	30142069013
Package	118 g in 1 BOTTLE (30142-690-13)
Marketing Start Date	2016-04-06
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL bc273e5f-76f4-4630-90bf-ae7f1213128e Details

Active Ingredients

Avobenzone 3.0%, Homosalate 8.0%, Octisalate 5.0%, Octocrylene 4.0%, Oxybenzone 4.0%

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

• May stain some fabrics

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

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 of 15 or higher and other sun protection measures including:

• limit time in the sun, especially from 10 a.m. to 2 p.m.

• wear long-sleeved shirts, pants, hats, and sunglasses

• children under 6 months: Ask a doctor

Inactive Ingredients

Water, Caprylyl Methicone, Glyceryl Stearate, PEG-100 Stearate, Cetyl Alcohol, Propylene Glycol, Silica, Benzyl Alcohol, Caprylyl Glycol, Diethylhexyl 2,6-Naphthalate, Phenoxyethanol, Sodium Polyacrylate, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Chlorphenesin, Cetyl Dimethicone, Dimethicone, Xanthan Gum, Fragrance, Behenyl Alcohol, Ethylhexyl Stearate, Trideceth-6, Disodium EDTA, Ethylhexylglycerin, BHT.

Other Information

• protect this product from excessive heat and direct sun

Questions or comments?

Call 1-800-632-6900

Principle Display Label

NDC: 30142-690-13

COMPARE TO

NEUTROGENA ULTRA SHEER

* see back panel

Kroger

SHEER

dry-touch sunscreen

Broad Spectrum SPF 30

Water Resistant (80 minutes)

Light Feel

Dermatologist Tested

Oil Free

Won't Clog Pores

UVA/UVB Protection

4 FL OZ (118mL)

INGREDIENTS AND APPEARANCE

KROGER SHEER DRY-TOUCH SFP 30

avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:30142-690
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	8 g in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	4 g in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
CETYL ALCOHOL (UNII: 936JST6JCN)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
XANTHAN GUM (UNII: TTV12P4NEE)
DOCOSANOL (UNII: 9G1OE216XY)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:30142-690-13	118 g in 1 BOTTLE; Type 0: Not a Combination Product	04/06/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	03/08/2016

Labeler - Krogers (006999528)

Revised: 3/2016

Document Id: 5023f272-34b2-4cfe-a049-128285349612

Set id: bc273e5f-76f4-4630-90bf-ae7f1213128e

Version: 2

Effective Time: 20160308