SKIN RESEARCH INSTITUTE NATURALLY BASED SUNSCREEN SPF 30- octinoxate and titanium dioxide lotion

Skin Research Institute Naturally Based Sunscreen SPF 30 by

Drug Labeling and Warnings

Skin Research Institute Naturally Based Sunscreen SPF 30 by is a Otc medication manufactured, distributed, or labeled by Cosmetic Solutions LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS:

ACTIVE INGREDIENTS

Titanium Dioxide 2.5%, Octinoxate 7%.

Purpose

Sunscreen

USES

Help prevent sunburn.

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 to all skin exposed to the sun. *Apply liberally and evenly 15 minutes before sun exposure. *Reapply after 40 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours. *For children under 6 months of age: 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.

INACTIVE INGREDIENTS

Water (Aqua), Aloe Barbadensis Leaf Extract, Isocetyl Stearate, Sorbitol, Cetearyl Alcohol, Ceteareth-20, Tocopheryl Acetate, Acetyl Hexapeptide-8, Hydrolyzed Rice Protein, Alcohol SDA-40, Dimethicone, Octyl Salicylate, Cetyl Alcohol, Methicone, Sodium Laureth Sulfate, Carbomer, Camellia Sinensis (Green Tea) Leaf Extract, Fragrance, Triethanolamine, Stearic Acid, Lecithin, Alumina, Caprylyl Glycol, Methylisothiazolinone.

OTHER INFORMATION

Protect the product in this container from excessive heat and direct sun.

PRINCIPAL DISPLAY PANEL - 58 mL Tube Label

SKIN
RESEARCH
INSTITUTE

PROTECT & MOISTURIZE

SPF
30

WATER RESISTANT - 40 MINS

NATURALLY BASED
SUNSCREEN

GOES ON CLEAR
NO HARSH CHEMICALS

NET WT. 1.96 FL OZ/ 58 mL
MADE IN USA

INGREDIENTS AND APPEARANCE

SKIN RESEARCH INSTITUTE NATURALLY BASED SUNSCREEN SPF 30 
octinoxate and titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66163-6504
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	70 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	25 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Isocetyl Stearate (UNII: 3RJ7186O9W)
Sorbitol (UNII: 506T60A25R)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Acetyl Hexapeptide-8 (UNII: L4EL31FWIL)
Dimethicone (UNII: 92RU3N3Y1O)
Octisalate (UNII: 4X49Y0596W)
Cetyl Alcohol (UNII: 936JST6JCN)
Methicone (20 Cst) (UNII: 6777U11MKT)
Sodium Laureth-3 Sulfate (UNII: BPV390UAP0)
Carboxypolymethylene (UNII: 0A5MM307FC)
Green Tea Leaf (UNII: W2ZU1RY8B0)
Trolamine (UNII: 9O3K93S3TK)
Stearic Acid (UNII: 4ELV7Z65AP)
Triethoxycaprylylsilane (UNII: LDC331P08E)
Aluminum Oxide (UNII: LMI26O6933)
Caprylyl Glycol (UNII: 00YIU5438U)
Methylisothiazolinone (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66163-6504-2	58 mL in 1 TUBE; Type 0: Not a Combination Product	01/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	01/01/2019

Labeler - Cosmetic Solutions LLC (807907928)