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NDC 70809-1911-02 SHINEBLOCK 11.6 mg/100mL Details

SHINEBLOCK 11.6 mg/100mL

SHINEBLOCK is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by USRX LLC. The primary component is ZINC OXIDE.

Product Information

NDC	70809-1911
Product ID	70809-1911_eaec9334-4dc7-6382-e053-2a95a90a6831
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	SHINEBLOCK
Proprietary Name Suffix	n/a
Non-Proprietary Name	Zinc Oxide
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	11.6
Active Ingredient Units	mg/100mL
Substance Name	ZINC OXIDE
Labeler Name	USRX LLC
Pharmaceutical Class	Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part352
Listing Certified Through	2023-12-31

Package

Package Images

NDC 70809-1911-02 (70809191102)

Pricing Information	N/A
NDC Package Code	70809-1911-2
Billing NDC	70809191102
Package	1 TUBE in 1 BOX (70809-1911-2) / 15 mL in 1 TUBE
Marketing Start Date	2021-06-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c790a30b-0262-3cda-e053-2995a90a0a0f Details

Drug Facts

Active Ingredients:

Zinc Oxide 11.6%

Purpose

Sunscreen

Use(s):

Helps prevent sunburn.

If used as directed with other sun protection measures (see directions), decreases the risk of skin canger 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.

Directions:

For sunscreen use:

Apply liberally and evenly 15 minutes before sun exposure
Reapply at least every 2 hours
Use a water resistant sunscreen if swimming or seating

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. to 2 p.m.
Wear long-sleeved shirts, pants, hats and sunglasses
Children under 6 months: ask a doctor

INACTIVE INGREDIENTS:

Water (Aqua), Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Undecylcrylene Dimethicone, Glycerin, Silica, Cetearyl Olivate, Polyester-8, Polyglyceryl-3 Beeswax, Tapioca Starch, Carthamus Tinctorius (Safflower) Oleosomes, Sorbitan Olivate, Propanediol, Polyhydroxystearic Acid, Potassium Cetyl Phosphate, Caprylyl Glycol, Xanthan Gum, Bisabolol, Caprylhydroxamic Acid, Cinnamomum Camphora (Camphor) Bark Oil, Mentha Piperita (Peppermint) Oil, Sodium Gluconate, Carthamus Tinctorius (Safflower) Seedcake Extract.

Other Information:

Protect the product in this container from excessive heat and direct sun.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SHINEBLOCK

zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70809-1911
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	11.6 mg in 100 mL

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
SODIUM GLUCONATE (UNII: R6Q3791S76)
PEPPERMINT OIL (UNII: AV092KU4JH)
CAMPHOR OIL (UNII: 75IZZ8Y727)
STARCH, TAPIOCA (UNII: 24SC3U704I)
SORBITAN OLIVATE (UNII: MDL271E3GR)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
PROPANEDIOL (UNII: 5965N8W85T)
XANTHAN GUM (UNII: TTV12P4NEE)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
LEVOMENOL (UNII: 24WE03BX2T)
UNDECYLCRYLENE DIMETHICONE (10000 MW) (UNII: HA26P2LA4P)
WATER (UNII: 059QF0KO0R)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70809-1911-1	1 in 1 BOX	07/20/2021
1		50 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
2	NDC:70809-1911-2	1 in 1 BOX	06/01/2021
2		15 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	06/01/2021

Labeler - USRX LLC (115270633)

Name	Address	ID/FEI	Business Operations
Establishment
Gordon Laboratories, Inc.		008328619	manufacture(70809-1911)

Revised: 10/2022

Document Id: eaec9334-4dc7-6382-e053-2a95a90a6831

Set id: c790a30b-0262-3cda-e053-2995a90a0a0f

Version: 3

Effective Time: 20221013