MIA DEL MAR SPF 30 MOISTURIZER- octinoxate, octisalate, octocrylene, avobenzone cream

Mia Del Mar SPF 30 Moisturizer by

Drug Labeling and Warnings

Mia Del Mar SPF 30 Moisturizer by is a Otc medication manufactured, distributed, or labeled by Product Management, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active Ingredients

Octinoxate 7.50%

Octisalate 5.00%

Octocrylene 5.00%

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:

Aloe Barbadensis (Aloe Vera Gel) Juice, Aqua (Deionized Water), Ascorbic Acid (Vitamin C), Bis-Vinyl Dimethicone/ Dimethicone Copolymer, Butylene Glycol, C12-15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Daucus Carota Sativa (Carrot) Seed Extract, Decyl Glucoside, Dimethicone, Glycerin, Isocetyl Stearate, Parfum (Fragrance), PEG-12 Dimethicone, Petrolatum, Phenoxyethanol, Phenyl Trimethicone, Polysorbate 20, Potassium Sorbate, Propylene Carbonate, Sodium Chloride (Dead Sea Salts), Sodium Metabisulfite, Sodium Polyacrylate, Sodium Stearate, Sorbitan Stearate, Sorbitol, Stearalkonium Hectorite, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Zemea (Corn) Propanediol.

OTHER INFORMATION:

Protect this product from excessive heat and direct sunlight.

Package Laebling:

INGREDIENTS AND APPEARANCE

MIA DEL MAR SPF 30 MOISTURIZER 
octinoxate, octisalate, octocrylene, avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71852-348
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DAUCUS CAROTA SUBSP. SATIVUS SEED (UNII: 9M6AAX381U)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
ISOCETYL STEARATE (UNII: 3RJ7186O9W)
PEG-12 DIMETHICONE (UNII: ZEL54N6W95)
PETROLATUM (UNII: 4T6H12BN9U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
SODIUM STEARATE (UNII: QU7E2XA9TG)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
SORBITOL (UNII: 506T60A25R)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
EDETATE SODIUM (UNII: MP1J8420LU)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CORN (UNII: 0N8672707O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71852-348-00	1 in 1 BOX	06/25/2018
1		60 mL in 1 TUBE; 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	06/25/2018

Labeler - Product Management, LLC (080906171)