SLMD MOISTURIZER WITH SPF- sunscreen lotion

SLMD Moisturizer with SPF by

Drug Labeling and Warnings

SLMD Moisturizer with SPF by is a Otc medication manufactured, distributed, or labeled by Owen Biosciences, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Octinoxate      7.50%
Oxybenzone    3.50%
Avobenzone    2.50%
Octisalate        1.50%

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

WarningsFor external use only 

Do not use on damaged or broken skin

When using this product

keep out of eyes. Rinse with water to remove.

skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time.  If irritation occurs, only use one topical acne medication at a time.

Keep out of reach of children.

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

Directions

• apply liberally and evenly 15 minutes before sun exposure
• reapply at least every 2 hours
• use a water resistant sunscreen if swimming or sweating:
• immediately after towel drying
• at least every two hours
• 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 thsi 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

PURPOSE

sunscreen

DOSAGE & ADMINISTRATION

topical sunscreen

Other information

• protect this product in this containerfrom excessive heat and direct sun
• may stain some fabrics

Inactive ingredients

Water
Emulsifying Wax NF
Cetyl Alcohol
Glycerin
DEA-Cetyl Phosphate
Dimethicone
Behentrimonium Methosulfate
Cetearyl Alcohol
Myristoyl Pentapeptide-17
Myristoyl Tetrapeptide-13
Ascorbyl Linoleate
Retinyl Linoleate
Lysophosphatidic acid
Panthenol
Allantoin
Arginine
Beta-Glucan
Sodium Carboxymethyl Beta-Glucan
Ethyl Macadamiate
Borago Officinalis Seed Oil
Triticum Vulgare (Wheat) Germ Oil
Tocopheryl Acetate
Retinyl Palmitate
Citrus Paradisi (Grapefruit) Fruit Extract
Camellia Sinensis Leaf Extract
Rosa Canina Fruit Extract
Hamamelis Virginiana (Witch Hazel) Extract
Polyglyceryl-3 Polyricinoleate
Polyglyceryl 5 Oleate
PPG-2 Myristyl Ether Propionate
Pentaerythrityl Tetracaprylate/Tetracaprate
Disodium EDTA
Caprylyl Glycol
Phenoxyethanol

Do not use

• on damaged or broken skin

Stop us and ask a doctor if

irritation becomes severe

Daily Moisturizer Back.jpg 

Daily Moisturizer Back.jpg

INGREDIENTS AND APPEARANCE

SLMD MOISTURIZER WITH SPF 
sunscreen lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59958-403
Route of Administration	Topical

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	7.5 g  in 100 g
Oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	Oxybenzone	3.5 g  in 100 g
Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	Avobenzone	2.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)	60.628 g  in 100 g
Cetyl Alcohol (UNII: 936JST6JCN)	2.5 g  in 100 g
Glycerin (UNII: PDC6A3C0OX)	2 g  in 100 g
CETYL PHOSPHATE (UNII: VT07D6X67O)	2.0 g  in 100 g
Dimethicone (UNII: 92RU3N3Y1O)	2 g  in 100 g
Behentrimonium Methosulfate (UNII: 5SHP745C61)	1 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59958-403-01	1 in 1 PACKAGE	04/05/2017
1		60 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/05/2017

Labeler - Owen Biosciences, Inc. (790003045)

Registrant - Owen Biosciences, Inc. (790003045)

Establishment
Name	Address	ID/FEI	Business Operations
Owen Biosciences, Inc.		790003045	manufacture(59958-403)