Label: SOLAIRE PEAU PARFAITE 100% MINERAL FLUID FLAWLESS SKIN- zinc oxide, titanium dioxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 51514-0354-1 - Packager: Autumn Harp, Inc.
- 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 February 7, 2019
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- Drug Facts
- Active Ingredients
- Purpose
- ACTIVE INGREDIENT
- Uses
- Warnings
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Directions
Apply generously and evenly every morning on cleansed face and neck 15 minutes before sun exposure
For sunscreen use:
- reapply at least every 2 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, regulary 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
- For use on children less than 6 months of age, consult a doctor.
- Other information
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Inactive ingredients
water, ethylhexyl palmitate, caprylic/capric triglyceride, cyclopentasiloxane, diisopropyl sebacate, isonoyl isononanoate, polyglyceryl-6 polyricinoleate, polymethylsilsesquioxane, glycerin, argania spinosa kernel oil, polyglyceryl-2 isostearate, tocopheryl acetate, silica, caesalpinia spinosa fruit extract, vaccinium vitis-idaea fruit ectract, kappaphycus alvarezii extract, terminalia ferdinandiana fruit extract, chlorella vulgaris extract, aloe barbadensis leaf juice powder, raspberry seed oil/tocopheryl succinate aminopropanediol esters, olive oil decyl esters, hydrolyzed pea protein, sea salt, squalene*, saccharide isomerate, bisabolol, isopropyl myristate, hydrogenated castor oil, xanthan gum, gluconolactone, calcium gluconate, hydrated silica, tocopherol, sodium chloride, magnesium stearate, disteardimonium hectorite, stearalkonium hectorite, propylene carbonate, polyhydroxystearic acid, bentonite, alumina, isopropyl titanium triisostearate, lactic acid, citric acid, phenoxyethanol, potassium sorbate, sodium benzoate, mica, iron oxides (CI 77491, CI 77492, CI 77499), titanium dioxide (CI 77891).
* Botanically derived
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INGREDIENTS AND APPEARANCE
SOLAIRE PEAU PARFAITE 100% MINERAL FLUID FLAWLESS SKIN
zinc oxide, titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51514-0354 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.5 mg in 100 mg ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 7.2 mg in 100 mg Inactive Ingredients Ingredient Name Strength FERRIC OXIDE YELLOW (UNII: EX438O2MRT) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FERROSOFERRIC OXIDE (UNII: XM0M87F357) TOCOPHEROL (UNII: R0ZB2556P8) SODIUM CHLORIDE (UNII: 451W47IQ8X) CALCIUM GLUCONATE (UNII: SQE6VB453K) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) GLUCONOLACTONE (UNII: WQ29KQ9POT) HYDRATED SILICA (UNII: Y6O7T4G8P9) MAGNESIUM STEARATE (UNII: 70097M6I30) STEARALKONIUM HECTORITE (UNII: OLX698AH5P) PROPYLENE CARBONATE (UNII: 8D08K3S51E) BENTONITE (UNII: A3N5ZCN45C) ALUMINUM OXIDE (UNII: LMI26O6933) ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM BENZOATE (UNII: OJ245FE5EU) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) SEA SALT (UNII: 87GE52P74G) POLYGLYCERYL-2 MONOISOSTEARATE (UNII: 7B8OE71MQC) ARGAN OIL (UNII: 4V59G5UW9X) LINGONBERRY (UNII: 0UNK9RZQ7X) SQUALENE (UNII: 7QWM220FJH) LEVOMENOL (UNII: 24WE03BX2T) XANTHAN GUM (UNII: TTV12P4NEE) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) CHLORELLA VULGARIS (UNII: RYQ4R60M02) ETHYLHEXYL PALMITATE (UNII: 2865993309) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIISOPROPYL SEBACATE (UNII: J8T3X564IH) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) KAPPAPHYCUS ALVAREZII (UNII: T479H08K2O) KAKADU PLUM (UNII: 0ZQ1D2FDLI) ALOE VERA LEAF (UNII: ZY81Z83H0X) OLIVE OIL DECYL ESTERS (UNII: 3AQ222F18X) SACCHARIDE ISOMERATE (UNII: W8K377W98I) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) LACTIC ACID, DL- (UNII: 3B8D35Y7S4) GLYCERIN (UNII: PDC6A3C0OX) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) WATER (UNII: 059QF0KO0R) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51514-0354-1 1 in 1 CARTON 05/01/2019 1 3000 mg in 1 TUBE; 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 02/07/2019 Labeler - Autumn Harp, Inc. (064187883) Registrant - Autumn Harp, Inc. (064187883) Establishment Name Address ID/FEI Business Operations Autumn Harp, Inc. 064187883 manufacture(51514-0354)
