NO BS MOISTURIZER SPF20- octinoxate, octisalate, avobenzone lotion

NO BS Moisturizer SPF20 by

Drug Labeling and Warnings

NO BS Moisturizer SPF20 by is a Otc medication manufactured, distributed, or labeled by Product Management, LLC, Pure Source, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active Ingredients

Octinoxate 5.00%

Octisalate 3.00%

Avobenzone 3.00%

Purpose

Sunscreen

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.

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 consult physician

• if irritation  or rash develops.

Keep out of reach of children. 

If product is swallowed, get medical attention or contact poison control center immediately.

DIRECTIONS:

Apply liberally 15 minutes before sun exposure.
Reapply:
- At least every two hours.
- Immediately after swimming, sweating, or towel drying.

SUN PROTECTION MEASURES:
Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including: - Limit time in the sun, especially between 10am and 2pm.
- Wear long sleeve shirts, pants, hats, and sunglasses.
- For children under six months, consult a physician.

OTHER INGREDIENTS:

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Algae Extract, C12-15 Alkyl Benzoate, Aqua (Deionized Water), Butylene Glycol, Butyrospermum Parkii (Shea) Butter, Camellia Sinensis (Green Tea) Leaf Extract, Caprylic/Capric Triglyceride, Carbomer, Cetearyl Alcohol, Cetearyl Glucoside, Citrus Aurantium Dulcis (Orange) Oil, Cocos Nucifera (Coconut) Oil, Ethoxydiglycol, Ethylhexylglycerin, Fucus Vesiculosus (Seaweed) Extract, Glycerin, Hyaluronic Acid, Hydrolyzed Collagen, Isopropyl Myristate, Isostearyl Palmitate, Mangifera Indica (Mango) Seed Butter, Moringa Oleifera (Moringa) Oil, Palmitoyl Oligopeptide, Palmitoyl Tetrapeptide-7, Phenoxyethanol, Polysorbate 20, Punica Granatum (Pomegranate) Extract, Retinol (Vitamin A), Saccharide Isomerate, Sodium Hydroxide, Sodium PCA, Tetrahexyldecyl Ascorbate (Vitamin C), Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate (Vitamin E).

OTHER INFORMATION:

Protect this product from excessive heat and direct sunlight.

Package Labeling:

INGREDIENTS AND APPEARANCE

NO BS MOISTURIZER SPF20 
octinoxate, octisalate, avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71852-334
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	50 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	30 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SHEA BUTTER (UNII: K49155WL9Y)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
ORANGE OIL (UNII: AKN3KSD11B)
COCONUT OIL (UNII: Q9L0O73W7L)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
NORI (UNII: 477TV3P5UX)
GLYCERIN (UNII: PDC6A3C0OX)
HYALURONIC ACID (UNII: S270N0TRQY)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ISOSTEARYL PALMITATE (UNII: 9EHU0R7ER1)
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POMEGRANATE (UNII: 56687D1Z4D)
RETINOL (UNII: G2SH0XKK91)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
COCOA BUTTER (UNII: 512OYT1CRR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71852-334-00	1 in 1 BOX	06/01/2018
1		50 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/01/2018

Labeler - Product Management, LLC (080906171)

Establishment
Name	Address	ID/FEI	Business Operations
Pure Source, LLC		080354456	manufacture(71852-334)