Moisturizer Maple day Cream SPF 15

Moisturizer Maple day SPF15 by

Drug Labeling and Warnings

Moisturizer Maple day SPF15 by is a Otc medication manufactured, distributed, or labeled by Kamins Dermatologics Inc., Odan Laboratories Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MOISTURIZER MAPLE DAY SPF15- moisturizer maple day spf15 cream 
Kamins Dermatologics Inc.

----------

Moisturizer Maple day Cream SPF 15

Purpose section: Sunscreen

A super emollient hydrating day cream with sunscreen to nourish deeply dry and dehydrated skin and supplement the skin’s diminished natural oils.

Uses:

Helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help sunburn, not skin cancer or early skin aging.

For external use only.

Do not use on damaged or broken skin.

When using this product keep out of eyes. If contact occurs, rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Keep out of the reach and sight of children.

If swallowed, seek medical assistance or contact a Poison Control Center immediately.

Directions

Apply liberally and evenly, each morning to cleansed face and neck, 15 minutes before sun exposure and as needed
Reapply at least every 2 hours
Use a water-resistant sunscreen if swimming or sweating
Children under 6 months of ages: ask a doctor.

Storage:

Protect the product in the container from excessive heat and direct sun.
Store between 15-30 °C

Inactive ingredients

Sodium Lactate, Sodium Phosphate, Dibasic, Anhydrous, Caprylyl Glycol, Squalane, Sorbic Acid, 1,1-Diphenylurea, Water, White Petrolatum, Glyceryl Stearate Se, PEG-75 Stearate, Ceteth-20, Steareth-20, Ricinus Communis Seed, Acer Saccharum Leaf, Tocopherol, Cholesterol, Monobasic Potassium Phosphate, Butylene Glycol, Fragrance Green Apple ORC2001072, Bovine Type II Collagen (Tracheal Cartilage) , Cetyl Alcohol, Dimethicone Crosspolymer (450000 Mpa.S At 12% In Cyclopentasiloxane), Sodium Chloride Dihydrate, Retinol, Phenoxyethanol

Principal display Panel:

B. KAMINS

Moisturizer Maple day Cream SPF15

DIN 02244222

50mL / 1.7 fl.oz

MOISTURIZER MAPLE DAY SPF15 
moisturizer maple day spf15 cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63550-108
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	45 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM LACTATE (UNII: TU7HW0W0QT)	50 mg  in 1 g
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)	1.7 mg  in 1 g
CAPRYLYL GLYCOL (UNII: 00YIU5438U)	4 mg  in 1 g
SQUALANE (UNII: GW89575KF9)	35 mg  in 1 g
SORBIC ACID (UNII: X045WJ989B)	4 mg  in 1 g
1,1-DIPHENYLUREA (UNII: H33D27I551)	50 mg  in 1 g
WATER (UNII: 059QF0KO0R)	35.8 mg  in 1 g
WHITE PETROLATUM (UNII: B6E5W8RQJ4)	80 mg  in 1 g
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)	12.5 mg  in 1 g
PEG-75 STEARATE (UNII: OT38R0N74H)	12.5 mg  in 1 g
CETETH-20 (UNII: I835H2IHHX)	12.5 mg  in 1 g
STEARETH-20 (UNII: L0Q8IK9E08)	12.5 mg  in 1 g
RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX)	20 mg  in 1 g
ACER SACCHARUM LEAF (UNII: VP8WP1ASR7)	50 mg  in 1 g
TOCOPHEROL (UNII: R0ZB2556P8)	10 mg  in 1 g
CHOLESTEROL (UNII: 97C5T2UQ7J)	10 mg  in 1 g
MONOBASIC POTASSIUM PHOSPHATE (UNII: 4J9FJ0HL51)	4.3 mg  in 1 g
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)	40 mg  in 1 g
FRAGRANCE GREEN APPLE ORC2001072 (UNII: U9GH30P956)	2.1 mg  in 1 g
BOVINE TYPE II COLLAGEN (TRACHEAL CARTILAGE) (UNII: 76TK29UQEZ)	40 mg  in 1 g
CETYL ALCOHOL (UNII: 936JST6JCN)	5 mg  in 1 g
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)	15 mg  in 1 g
SODIUM CHLORIDE DIHYDRATE (UNII: 70521YQ49G)	10 mg  in 1 g
RETINOL (UNII: G2SH0XKK91)	0.9 mg  in 1 g
PHENOXYETHANOL (UNII: HIE492ZZ3T)	4 mg  in 1 g

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63550-108-01	50 g in 1 BOX; Type 0: Not a Combination Product	11/01/2001	12/31/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	11/01/2001	12/31/2023

Labeler - Kamins Dermatologics Inc. (254050784)

Registrant - Odan Laboratories Ltd (208585604)

Establishment
Name	Address	ID/FEI	Business Operations
Odan Laboratories Ltd		208585604	manufacture(63550-108) , analysis(63550-108)

Revised: 6/2024

Document Id: 834a268c-1407-4a0d-b067-292d1ba6c076

34390-5

Set id: b63443c2-d889-7548-e053-2995a90a0f40

Version: 4

Effective Time: 20240610