SOLEIL BROAD SPECTRUM SPF-50- octinoxate, octisalate, zinc oxide spray

Soleil Broad Spectrum SPF-50 by

Drug Labeling and Warnings

Soleil Broad Spectrum SPF-50 by is a Otc medication manufactured, distributed, or labeled by The Soleil Group, LLC, Pure Source. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Keep out of reach of children

ACTIVE INGREDIENT

Octinoxate 5.0%, Octisalate
3.0%, Zinc Oxide 2.5%

INACTIVE INGREDIENT

Uses

Helps prevent sunburn. If used as directed with other
sun protection measures (see Directions: ), decreases the risk
of skin cancer and early skin aging caused by the sun.

PURPOSE

Sunscreen

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

May stain or damage some fabrics or
surfaces. Avoid long term storage above 40°C (120°F).
Protect this product from excessive heat and direct sun.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SOLEIL BROAD SPECTRUM SPF-50 
octinoxate, octisalate, zinc oxide spray

Product 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)