Label: MINERALIZE MOISTURE SPF 15 FOUNDATION- octinoxate and titanium dioxide liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 40046-0061-1 - Packager: MAKEUP ART COSMETICS
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated July 23, 2012
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Use
- Warnings
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Directions
For sunscreen use:
- apply liberally 15 minutes before sun exposure
- reapply 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 of age: ask a doctor
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inactive ingredients
water\aqua\eau, peg-30 dipolyhydroxystearate, dimethicone, ethylhexyl palmitate, caprylic/capric triglyceride, neopentyl glycol diethylhexanoate, triethylhexanoin, butylene glycol, glycerin, octyldodecyl neopentanoate, squalane, silica, tocopherol, tocopheryl acetate, sodium hyaluronate, lysine, butyrospermum parkii (shea butter), haberlea rhodopensis leaf extract, tamarindus indica seed extract, beta vulgaris (beet) root extract\beta vulgaris\extrait de racine de betterave, yeast extract\faex\extrait de levure, phytantriol, octyldodecyl pca, sodium pca, trehalose, magnesium chloride, sodium chloride, potassium chloride, zinc chloride, simethicone, synthetic fluorphlogopite, disteardimonium hectorite, polyglyceryl-3 beeswax, triethoxycaprylylsilane, dimethicone crosspolymer-3, tin oxide, urea, triacetin, polyquaternium-51, caprylyl glycol, hexylene glycol, hydrogenated lecithin, disodium edta, phenoxyethanol, sodium dehydroacetate [+/- mica, titanium dioxide (ci 77891), iron oxides (ci 77491), iron oxides (ci 77492), iron oxides (ci 77499)] <iln 39648>
- Other Information
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 30 ML Bottle Carton
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INGREDIENTS AND APPEARANCE
MINERALIZE MOISTURE SPF 15 FOUNDATION
octinoxate and titanium dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:40046-0061 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 mL in 100 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2 mL in 100 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) peg-30 dipolyhydroxystearate (UNII: 9713Q0S7FO) dimethicone (UNII: 92RU3N3Y1O) ethylhexyl palmitate (UNII: 2865993309) medium-chain triglycerides (UNII: C9H2L21V7U) neopentyl glycol diethylhexanoate (UNII: U68ZV6W62C) triethylhexanoin (UNII: 7K3W1BIU6K) butylene glycol (UNII: 3XUS85K0RA) glycerin (UNII: PDC6A3C0OX) octyldodecyl neopentanoate (UNII: X8725R883T) squalane (UNII: GW89575KF9) silicon dioxide (UNII: ETJ7Z6XBU4) tocopherol (UNII: R0ZB2556P8) .alpha.-tocopherol acetate (UNII: 9E8X80D2L0) hyaluronate sodium (UNII: YSE9PPT4TH) lysine (UNII: K3Z4F929H6) shea butter (UNII: K49155WL9Y) haberlea rhodopensis leaf (UNII: N042Q65701) tamarind seed (UNII: 6AHP8A7OML) beta vulgaris (UNII: 4G174V5051) yeast (UNII: 3NY3SM6B8U) phytantriol (UNII: 8LVI07A72W) sodium pyrrolidone carboxylate (UNII: 469OTG57A2) trehalose (UNII: B8WCK70T7I) magnesium chloride (UNII: 02F3473H9O) sodium chloride (UNII: 451W47IQ8X) potassium chloride (UNII: 660YQ98I10) zinc chloride (UNII: 86Q357L16B) triethoxycaprylylsilane (UNII: LDC331P08E) stannic oxide (UNII: KM7N50LOS6) urea (UNII: 8W8T17847W) triacetin (UNII: XHX3C3X673) caprylyl glycol (UNII: 00YIU5438U) hexylene glycol (UNII: KEH0A3F75J) edetate disodium (UNII: 7FLD91C86K) phenoxyethanol (UNII: HIE492ZZ3T) sodium dehydroacetate (UNII: 8W46YN971G) mica (UNII: V8A1AW0880) ferric oxide red (UNII: 1K09F3G675) ferric oxide yellow (UNII: EX438O2MRT) ferrosoferric oxide (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:40046-0061-1 1 in 1 CARTON 1 30 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 07/02/2012 Labeler - MAKEUP ART COSMETICS (010597206) Establishment Name Address ID/FEI Business Operations ELGC K.K. 712808195 RELABEL(40046-0061) , REPACK(40046-0061) Establishment Name Address ID/FEI Business Operations Estee Lauder Pennsylvania Distribution Center 2 (PADC 2) 828534516 MANUFACTURE(40046-0061) , RELABEL(40046-0061) , REPACK(40046-0061) Establishment Name Address ID/FEI Business Operations Estee Lauder Inc. 042918826 MANUFACTURE(40046-0061) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS DISTRIBUTION CENTER 208579636 RELABEL(40046-0061) , REPACK(40046-0061) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 253616536 MANUFACTURE(40046-0061) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 244669714 MANUFACTURE(40046-0061) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD. 205952385 MANUFACTURE(40046-0061) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER N.V. 370151326 MANUFACTURE(40046-0061) Establishment Name Address ID/FEI Business Operations LEN-RON MANUFACTURING DIVISION OF ARAMIS INC 809771152 MANUFACTURE(40046-0061) Establishment Name Address ID/FEI Business Operations NORTEC KEYSTONE 943871157 MANUFACTURE(40046-0061) , RELABEL(40046-0061) , REPACK(40046-0061) Establishment Name Address ID/FEI Business Operations NORTHTEC BRISTOL 959338336 MANUFACTURE(40046-0061) , RELABEL(40046-0061) , REPACK(40046-0061) Establishment Name Address ID/FEI Business Operations NORTHTEC KEYSTONE 949264774 MANUFACTURE(40046-0061) , RELABEL(40046-0061) , REPACK(40046-0061) Establishment Name Address ID/FEI Business Operations WHITMAN LABORATORIES, LTD. 216866277 MANUFACTURE(40046-0061) Establishment Name Address ID/FEI Business Operations Aveda Corporation 071352058 MANUFACTURE(40046-0061) Establishment Name Address ID/FEI Business Operations Pennsylvania Logistics Center 078364654 REPACK(40046-0061) , RELABEL(40046-0061) Establishment Name Address ID/FEI Business Operations MANA PRODUCTS, INC. 078870292 MANUFACTURE(40046-0061)
