Label: SOLEIL TOUJOURS SPF 15 SHEER SUNSCREEN- avobenzone, octisalate spray
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Contains inactivated NDC Code(s)
NDC Code(s): 13630-0133-4 - Packager: Prime Packaging 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, 2020
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
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Warnings
For external use only
Flammable: Contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120ºF. Do not use in the presence of a flame or spark, or while smoking.
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Directions
- Shake well • apply liberally 15 minutes before sun exposure
- reapply: • after 80 minutes of swimming and 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 a 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 ingredients
Artemesia Pallens Flower Oil, Aloe Barbadensis Leaf Juice, Ascorbyl Palmitate, Bisabolol, Camellia Oleifera (Green Tea) Leaf Extract, Caprylic/Capric Triglyceride, Citrus Aurantifolia Peel Oil, Citrus Aurantium Bergamia Fruit Extract, Citrus Limon Peel Oil, Citrus Nobilis Flower Oil, Citrus Sinensis Peel Oil, Cucumis Sativus (Cucumber) Extract, Ethyl Acetate, Ethyl Acetoacetate, Ferula Galbaniflua Resin Oil, Gamma Undecalactone, Glycerin, Heliotropine, Isoamyl Acetate, Isobutyl Acetate, Jasminum Sambac Oil, Opoponax Oil, Polyester-8, Porphyra Umbilicalis Extract, Salvia Sclarea Oil, SD Alcohol 40-B, Sodium Hyaluronate, Tetrahexyldecyl Ascorbate, Tocopherol, Tocopheryl Acetate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Water
- Other information
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- Soleil Toujours SPF 15 Sheer Sunscren Mist
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INGREDIENTS AND APPEARANCE
SOLEIL TOUJOURS SPF 15 SHEER SUNSCREEN
avobenzone, octisalate sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13630-0133 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 16.52 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 41.3 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) ASCORBYL PALMITATE (UNII: QN83US2B0N) LEVOMENOL (UNII: 24WE03BX2T) GALBANUM OIL (UNII: 211UF7M8N1) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) OPOPANAX RESIN (UNII: TA8L57B94W) ORANGE OIL (UNII: AKN3KSD11B) BERGAMOT OIL (UNII: 39W1PKE3JI) DAVANA OIL (UNII: CL439Y041G) WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) .GAMMA.-UNDECALACTONE (UNII: QB1T0AG2YL) PIPERONAL (UNII: KE109YAK00) ISOBUTYL ACETATE (UNII: 7CR47FO6LF) GLYCERIN (UNII: PDC6A3C0OX) ISOAMYL ACETATE (UNII: Z135787824) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CUCUMBER JUICE (UNII: 61845009SP) PORPHYRA UMBILICALIS (UNII: 14AN0J70WO) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) HYALURONATE SODIUM (UNII: YSE9PPT4TH) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) VINYL ACETATE (UNII: L9MK238N77) DIBUTYL MALEATE (UNII: 4X371TMK9K) ISOBORNYL ACRYLATE (UNII: IX0PRH184P) TOCOPHEROL (UNII: R0ZB2556P8) CLARY SAGE OIL (UNII: 87L0D4U3M0) ETHYL ACETOACETATE (UNII: IZP61H3TB1) LEMON OIL (UNII: I9GRO824LL) LIME OIL (UNII: UZH29XGA8G) CITRUS NOBILIS (UNII: 8MFF77J91V) JASMINUM SAMBAC WHOLE (UNII: 1Z81V275I0) ETHYL ACETATE (UNII: 76845O8NMZ) Product Characteristics Color yellow (Colorless to Pale Yellow) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13630-0133-4 177 mL in 1 CAN; Type 0: Not a Combination Product 04/13/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 04/13/2017 Labeler - Prime Packaging Inc. (805987059) Registrant - Prime Packaging Inc. (805987059) Establishment Name Address ID/FEI Business Operations Prime Enterprises Inc 101946028 manufacture(13630-0133) , analysis(13630-0133) Establishment Name Address ID/FEI Business Operations Prime Packaging Inc. 805987059 pack(13630-0133) , label(13630-0133)
