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NDC 69630-0639-01 Soleil Broad Spectrum SPF 30 Sunscreen Body Creme 75; 35 mg/mL; mg/mL Details

Soleil Broad Spectrum SPF 30 Sunscreen Body Creme 75; 35 mg/mL; mg/mL

Soleil Broad Spectrum SPF 30 Sunscreen Body Creme is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Soleil Group, LLC. The primary component is OCTINOXATE; TITANIUM DIOXIDE.

Product Information

NDC	69630-0639
Product ID	69630-639_47f5441d-e6d2-0485-e054-00144ff8d46c
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Soleil Broad Spectrum SPF 30 Sunscreen Body Creme
Proprietary Name Suffix	n/a
Non-Proprietary Name	OCTINOXATE, TITANIUM DIOXIDE
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	75; 35
Active Ingredient Units	mg/mL; mg/mL
Substance Name	OCTINOXATE; TITANIUM DIOXIDE
Labeler Name	Soleil Group, LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part352
Listing Certified Through	2023-12-31

Package

Package Images

NDC 69630-0639-01 (69630063901)

Pricing Information	N/A
NDC Package Code	69630-639-01
Billing NDC	69630063901
Package	1 TUBE in 1 BOX (69630-639-01) / 120 mL in 1 TUBE
Marketing Start Date	2017-02-07
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 7f7e4be3-2b5b-4bc1-a3f9-b16a708dc6a2 Details

Drug Facts

Active Ingredients:

Octinoxate 7.5%

Titanium Dioxide 3.5%

Purpose

Sunscreen

Uses:

• Helps prevent sunburn

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

Inactive Ingredients:

A-bisabolol, algae extract, aloe barbadensis leaf (aloe vera gel) juice*, aqua (deionized water), camellia sinensis leaf (green tea) extract*, carthamus tinctorius (safflower) oil*, cetearyl alcohol, citrullus lanatus (watermelon) extract, citrus aurantifolia fruit oil, citrus aurantium dulcis peel oil, citrus limon peel oil, citrus reticulata leaf oil, commiphora myrrha resin oil, cyclomethicone, dimethicone, gluconolactone, glycerin*, helianthus annuus (sunflower) oil*, isopropyl palmitate, menthapiperita stem/leaf oil, mentha viridis leaf oil, microcrystalline wax, myristica fragrans kernel oil, pogostemon cablin oil, rosa damascena flower oil, salvia scalrea oil, santalum spicata wood oil, sdoium benzoate, tetrahexyldecyl ascorbate (vitamin C), thymus vulgaris oil, tocopherol acetate (vitamin E). *Organic 68.77%

Warnings:

For external use only

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 product is swallowed, get medical help or contact a Poison Control Center right away.

Directions:

• Apply liberally 15 minutes before sun exposure

• Use a water resistant sunscreen if swimming or sweating

• Reapply

• immediately after swimming, sweating or towel drying

• at least every 2 hours

• Children under 6 months: Ask a doctor

• 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 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

Other Information:

Protect the product in this container from excessive heat and direct sunlight

Questions or comments:

Call 917-338-7291

Product Label

INGREDIENTS AND APPEARANCE

SOLEIL BROAD SPECTRUM SPF 30 SUNSCREEN BODY CREME

octinoxate, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69630-639
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	35 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
SAFFLOWER OIL (UNII: 65UEH262IS)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
WATERMELON (UNII: 231473QB6R)
CITRUS AURANTIIFOLIA FRUIT OIL (UNII: 7937R189CB)
ORANGE PEEL (UNII: TI9T76XD44)
MYRRH OIL (UNII: H74221J5J4)
CYCLOMETHICONE (UNII: NMQ347994Z)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
GLYCERIN (UNII: PDC6A3C0OX)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
PEPPERMINT OIL (UNII: AV092KU4JH)
SPEARMINT OIL (UNII: C3M81465G5)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PATCHOULI OIL (UNII: F3IN55X5PO)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
CASTOR OIL (UNII: D5340Y2I9G)
ROSA DAMASCENA FLOWER OIL (UNII: 18920M3T13)
SALVIA SCLAREA SEED OIL (UNII: JK0RP5O3HW)
SANTALUM SPICATUM OIL (UNII: H9LVS6REV4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
THYME OIL (UNII: 2UK410MY6B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69630-639-01	1 in 1 BOX	02/07/2017
1		120 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	03/25/2015

Labeler - Soleil Group, LLC (079694651)

Name	Address	ID/FEI	Business Operations
Establishment
Pure Source, LLC		080354456	manufacture(69630-639)

Revised: 2/2017

Document Id: 47f5441d-e6d2-0485-e054-00144ff8d46c

Set id: 7f7e4be3-2b5b-4bc1-a3f9-b16a708dc6a2

Version: 7

Effective Time: 20170207