Label: SOLEIL TOUJOURS BROAD SPECTRUM SPF 30 SUNSCREEN- avobenzone, homosalate, octisalate lotion
- NDC Code(s): 58443-0518-3
- Packager: Prime Enterprises Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 January 17, 2022
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
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Directions
- Shake well before use
- with your eyes completely closed, mist face evenly, holding bottle 10-12 inches awat from face. Do not breathe mist in. Allow to fully dry.
- apply liberally 15 minutes before sun exposure
- reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
- 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 broad spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses
- Children under 6 months: Ask a doctor
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INACTIVE INGREDIENT
Abies siberica Needle Oil, Aloe Barbadensis Leaf Juice, Ascorbyl Palmitate, Bisabolol, Camellia Oleifera (Green Tea) Leaf Extract, Caprylic/Capric Triglyceride, Citrus aurantifolia Fruit Oil, Citrus aurantium bergamia Fruit Extract, Citrus aurantium dulcis Peel Oil, Citrus grandis Peel Oil, Citrus limon Peel Oil, Citrus nobilis Peel Oil, Citrus reticulata Leaf Oil, Commiphora myrrha Resin Oil, Cucumis Sativus (Cucumber) Extract, Ethyl Vanillin, Eucalyptus globulus Leaf Oil, Ferula galbaniflua Oil, Glycerin, Juniperus virginiana Oil, Lavandula angustifolia Oil, Mentha piperita Stem/Leaf Oil, Mentha viridis Leaf Oil, Myristica fragrans Kernel Oil, Pelargonium graveolens Flower Oil, Pogostemon cablin Oil, Polyester-8, Porphyra Umbilicalis Extract, Rosa damascena Flower Oil, Salvia sclarea Oil, Santalum spicata Wood Oil, SD Alcohol 40-B, Sodium Hyaluronate, Tetrahexyldecyl Ascorbate, Thymus vulgaris Oil, Tocopheryl Acetate, Triethyl Citrate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Vanillin, Water
- Other Information
- Question or comments?
- Soleil Toujours SPF 30 Makeup Setting Spray Sunscreen
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INGREDIENTS AND APPEARANCE
SOLEIL TOUJOURS BROAD SPECTRUM SPF 30 SUNSCREEN
avobenzone, homosalate, octisalate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0518 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 41.85 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 25.11 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 62.78 mg in 1 mL Inactive Ingredients Ingredient Name Strength BERGAMOT OIL (UNII: 39W1PKE3JI) ORANGE PEEL (UNII: TI9T76XD44) ALOE VERA LEAF (UNII: ZY81Z83H0X) GLYCERIN (UNII: PDC6A3C0OX) GREEN TEA LEAF (UNII: W2ZU1RY8B0) WATER (UNII: 059QF0KO0R) LEMON OIL, COLD PRESSED (UNII: I9GRO824LL) CITRUS NOBILIS (UNII: 8MFF77J91V) LEVOMENOL (UNII: 24WE03BX2T) CITRUS AURANTIIFOLIA FRUIT OIL (UNII: 7937R189CB) CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44) CITRUS RETICULATA LEAF OIL (UNII: 1515UE78IH) SPEARMINT OIL (UNII: C3M81465G5) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) SANTALUM SPICATUM OIL (UNII: H9LVS6REV4) ALCOHOL (UNII: 3K9958V90M) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) VANILLIN (UNII: CHI530446X) MENTHA PIPERITA LEAF (UNII: A389O33LX6) POGOSTEMON CABLIN LEAF OIL (UNII: F3IN55X5PO) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) THYME OIL (UNII: 2UK410MY6B) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) GALBANUM OIL (UNII: 211UF7M8N1) JUNIPERUS VIRGINIANA OIL (UNII: PAD4FN7P2G) LAVENDER OIL (UNII: ZBP1YXW0H8) MYRRH OIL (UNII: H74221J5J4) CUCUMBER (UNII: YY7C30VXJT) EUCALYPTUS OIL (UNII: 2R04ONI662) ROSA DAMASCENA FLOWER OIL (UNII: 18920M3T13) CLARY SAGE OIL (UNII: 87L0D4U3M0) PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC) ABIES SIBIRICA WHOLE (UNII: 80YP21OD21) ETHYL VANILLIN (UNII: YC9ST449YJ) NUTMEG OIL (UNII: Z1CLM48948) PORPHYRA UMBILICALIS (UNII: 14AN0J70WO) HYALURONATE SODIUM (UNII: YSE9PPT4TH) ASCORBYL PALMITATE (UNII: QN83US2B0N) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) Product Characteristics Color yellow (Very Light Yellow) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58443-0518-3 50 mL in 1 TUBE; Type 0: Not a Combination Product 08/30/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 08/30/2016 Labeler - Prime Enterprises Inc. (101946028) Registrant - Prime Enterprises Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises Inc. 101946028 pack(58443-0518) , manufacture(58443-0518) , label(58443-0518) , analysis(58443-0518)
