Label: SOLEIL BROAD SPECTRUM SPF-50- octinoxate, octisalate, zinc oxide spray
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Contains inactivated NDC Code(s)
NDC Code(s): 69630-003-50 - Packager: The Soleil Group, LLC
- 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 February 26, 2015
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- Official Label (Printer Friendly)
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WARNINGS
For external use only. Flammable: Do not use
near heat, flame, or while smoking. Do not use on damaged
or broken skin. When using this product keep out of eyes.
Rinse with water to remove. Stop use and ask a doctor if rash
occurs. Keep out of reach of children. If the product is
swallowed, get medical help or contact a Poison Control
Center immediately. - KEEP OUT OF REACH OF CHILDREN
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- Uses
- PURPOSE
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Directions
Apply liberally 20 minutes prior to sun
exposure. Do not spray onto face. Spray into hands and apply
to face. Use in well-ventilated areas. Reapply: immediately
after swimming, sweating or towel drying and 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. - Other Information
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SOLEIL BROAD SPECTRUM SPF-50
octinoxate, octisalate, zinc oxide sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69630-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 6 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 3 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 mg in 1 mL Inactive Ingredients Ingredient Name Strength METHACRYLATE/METHOXY PEG-10 MALEATE/STYRENE COPOLYMER (UNII: 39DK5WQ2PR) FUCUS VESICULOSUS (UNII: 535G2ABX9M) ALOE VERA LEAF (UNII: ZY81Z83H0X) water (UNII: 059QF0KO0R) ARTEMISIA PALLENS WHOLE (UNII: 39JKR5IL2G) LEVOMENOL (UNII: 24WE03BX2T) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CAPRYLIC/CAPRIC/LINOLEIC TRIGLYCERIDE (UNII: U73D397055) CETYL ALCOHOL (UNII: 936JST6JCN) CETEARYL OLIVATE (UNII: 58B69Q84JO) CITRUS AURANTIUM FLOWER OIL (UNII: D4BGE91OXH) CITRUS AURANTIUM FRUIT (UNII: DQD16J2B5O) CITRUS LIMON FRUIT OIL (UNII: 0HNC1J1YED) CITRUS NOBILIS (UNII: 8MFF77J91V) CITRUS SINENSIS FRUIT OIL (UNII: WV48LBL15Q) CARROT (UNII: L56Z1JK48B) ETHYL ACETOACETATE (UNII: IZP61H3TB1) EUCALYPTUS GLOBULUS WHOLE (UNII: SI1P2XF3M3) GLUCONOLACTONE (UNII: WQ29KQ9POT) GLYCERIN (UNII: PDC6A3C0OX) SUNFLOWER OIL (UNII: 3W1JG795YI) PIPERONAL (UNII: KE109YAK00) ISOAMYL ACETATE (UNII: Z135787824) ISOBUTYL ACETATE (UNII: 7CR47FO6LF) JASMINUM SAMBAC WHOLE (UNII: 1Z81V275I0) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) OPOPANAX CHIRONIUM WHOLE (UNII: 0LGQ3H5EXR) POLYSORBATE 20 (UNII: 7T1F30V5YH) PEG/PPG-17/6 COPOLYMER (UNII: P5QZM4T259) SALVIA SCLAREA SEED OIL (UNII: JK0RP5O3HW) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITAN OLIVATE (UNII: MDL271E3GR) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PROPANEDIOL (UNII: 5965N8W85T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69630-003-50 177.4 mL in 1 BOTTLE, SPRAY Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 02/13/2015 Labeler - The Soleil Group, LLC (079694651) Establishment Name Address ID/FEI Business Operations Pure Source 969241041 manufacture(69630-003)
