Label: INTRAL SENSITIVE SKIN ENVIRONMENTAL LIGHTWEIGHT SHIELD BROAD SPECTRUM SPF50- titanium dioxide and zinc oxide lotion
- NDC Code(s): 16555-008-01
- Packager: DARPHIN DIST.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 11, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
- Uses
- Warnings
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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
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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
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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
- PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton
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INGREDIENTS AND APPEARANCE
INTRAL SENSITIVE SKIN ENVIRONMENTAL LIGHTWEIGHT SHIELD BROAD SPECTRUM SPF50
titanium dioxide and zinc oxide lotionProduct 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 63 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 40 mg in 1 mL Inactive Ingredients Ingredient Name Strength FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) PHENOXYETHANOL (UNII: HIE492ZZ3T) 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 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 Drug M020 07/15/2017 Labeler - DARPHIN DIST. (105157494) Registrant - Estee Lauder Companies Inc. (790802086) Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics Ltd. 202952982 manufacture(16555-008) Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics Ltd. 204132062 pack(16555-008) , label(16555-008) Establishment Name Address ID/FEI Business Operations The Estee Lauder Inc 802599436 manufacture(16555-008)
