SHINEBLOCK by USRX LLC / Gordon Laboratories, Inc. ShineBlock 70809-1911

Drug Details [pdf]

SHINEBLOCK- zinc oxide cream
USRX LLC

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ShineBlock 70809-1911

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.

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 Drug	M020	06/01/2021	01/30/2023

Labeler - USRX LLC (115270633)

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

Revised: 10/2024

Document Id: 236fee3b-15ef-95f0-e063-6394a90a0b1c

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

Version: 5

Effective Time: 20241001

Trademark Results [SHINEBLOCK]

Mark Image Registration \| Serial	Company Trademark Application Date
SHINEBLOCK 90533785 not registered Live/Pending	USRX, LLC 2021-02-18