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

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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INTRAL SENSITIVE SKIN ENVIRONMENTAL LIGHTWEIGHT SHIELD BROAD SPECTRUM SPF50

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:

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.

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton
INTRAL SENSITIVE SKIN ENVIRONMENTAL LIGHTWEIGHT SHIELD BROAD SPECTRUM SPF50 
titanium dioxide and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16555-008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE63 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE40 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
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)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:16555-008-011 in 1 CARTON07/15/2017
130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02007/15/2017
Labeler - DARPHIN DIST. (105157494)
Registrant - Estee Lauder Companies Inc. (790802086)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics Ltd.202952982manufacture(16555-008)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics Ltd.204132062pack(16555-008) , label(16555-008)
Establishment
NameAddressID/FEIBusiness Operations
The Estee Lauder Inc802599436manufacture(16555-008) , pack(16555-008) , label(16555-008)

Revised: 8/2023
Document Id: 037058e3-f818-51d5-e063-6394a90a9361
Set id: 91277514-4db0-4b40-b95a-3530cac711df
Version: 8
Effective Time: 20230821
 
DARPHIN DIST.