INTRAL SENSITIVE SKIN ENVIRONMENTAL LIGHTWEIGHT SHIELD BROAD SPECTRUM SPF50- titanium dioxide and zinc oxide lotion

INTRAL SENSITIVE SKIN ENVIRONMENTAL LIGHTWEIGHT SHIELD BROAD SPECTRUM SPF50 by

Drug Labeling and Warnings

INTRAL SENSITIVE SKIN ENVIRONMENTAL LIGHTWEIGHT SHIELD BROAD SPECTRUM SPF50 by is a Otc medication manufactured, distributed, or labeled by DARPHIN DIST., Estee Lauder Companies Inc., PALC, Estee Lauder Cosmetics Ltd., Whitman Laboratories Ltd., Estee Lauder N.V., The Estee Lauder Inc, Northtec LLC, PADC 1. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Titanium dioxide 6.3%
Zinc oxide 4.0%

Purpose

Sunscreen

Uses

Helps prevent sunburn

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 15 minutes before sun exposure
• reapply at least every two hours
• use a water resistant sunscreen if swimming or sweating
• 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
  • children under 6 months: ask a doctor

Inactive ingredients

water\aqua\eau, dimethicone, butyloctyl salicylate, polydiethylsiloxane, c12-15 alkyl benzoate, isononyl isononanoate, diethylhexyl succinate, neopentyl glycol diheptanoate, methyl trimethicone, butylene glycol, ethylhexyl methoxycrylene, lauryl peg-9 polydimethylsiloxyethyl dimethicone, silica, laureth-4, cetyl peg/ppg-10/1 dimethicone, dipentaerythrityl tri-polyhydroxystearate, dimethicone silylate, hydrolyzed wheat protein/pvp crosspolymer, isostearic acid, caprylyl glycol, dimethicone crosspolymer-3, polyhydroxystearic acid, triethoxycaprylylsilane, dimethicone/peg-10/15 crosspolymer, dipropylene glycol, phenoxyethanol, iron oxides (ci 77491), iron oxides (ci 77492) <iln41905>

Other information

protect the product in this container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

DARPHIN
PARIS

INTRAL

SENSITIVE SKIN

ENVIRONMENTAL
LIGHTWEIGHT SHIELD

BROAD SPECTRUM
SPF 50

30 ml e/1 FL.OZ.LIQ.

INGREDIENTS AND APPEARANCE

INTRAL SENSITIVE SKIN ENVIRONMENTAL LIGHTWEIGHT SHIELD BROAD SPECTRUM SPF50 
titanium dioxide and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 16555-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	66.64 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	42.2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
LAURETH-4 (UNII: 6HQ855798J)
DIPENTAERYTHRITYL TRI-POLYHYDROXYSTEARATE (UNII: D21K655H52)
ISOSTEARIC ACID (UNII: X33R8U0062)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 16555-008-01	1 in 1 CARTON	07/15/2017
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	07/15/2017

Labeler - DARPHIN DIST. (105157494)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(16555-008) , REPACK(16555-008)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(16555-008)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(16555-008)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(16555-008)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(16555-008)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(16555-008) , REPACK(16555-008)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(16555-008) , REPACK(16555-008)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(16555-008)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(16555-008)