SPF 30 FACE MOISTURIZER- avobenzone, homosalate, octinoxate, octisalate, oxybenzone lotion

SPF 30 face Moisturizer by

Drug Labeling and Warnings

SPF 30 face Moisturizer by is a Otc medication manufactured, distributed, or labeled by Malin and Goetz Inc, Milbar Laboratories,Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient        Purpose

Avobenzone 3%        sunscreen

Homosalate 10%      sunscreen

Octinoxate 7.5%       sunscreen

Octisalate 2.75%      sunscreen

Oxybenzone 5%       sunscreen

PURPOSE

Uses

• Helps prevent sunburn

• If used as directed with other sun proctection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun
• Retains SPF up to 80 minutes of activity in the water

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away

INDICATIONS & USAGE

Stop use and ask a doctor if:  Rash or irritation develops and lasts.

WARNINGS

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.

DOSAGE & ADMINISTRATION

Directions

• Apply liberally and evenly to dry skin 15 minutes before sun exposure and as often as needed.
• Re-apply at least every 2 hours; after 80 minutes of  swimming or perspiring; immediately after towel drying.
• Children under 6 months of age, consult your physician
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regualarly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
•   Limit time in the sun from 10am-2pm
• wear long sleeve shirts, pants, hats and sunglasses

INACTIVE INGREDIENT

Water(Aqua), Butyloctyl Salicylate, Dimethicone, Corn Start Modified, Hexylene Glycol, VP/Eicosene Copolymer, Glcyerin, Cetearyl Alcohol, PEG-12 Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Panthenol, Allantoin, Aloe Barbadensis Leaf Juice Powder, Butyrospermum Parkii (shea) Oil, Epilobium Angustifolium Flower/leaf/stem extract, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sorbitan Stearate, Xanthan Gum, Caprylyl Glycol, Ethylhexylglycerin, Calcium Pantothenate, Sodium Hydroxide, Chlorphenesin, Disodium EDTA, Potassium Sorbate, PEG-40 Stearate, Phenoxyethanol

PRINCIPAL DISPLAY PANEL

(Malin + Goetz)

SPF 30 Face Moisturizer

Broad Spectrum SPF 30 All skin types

Water Resistant

1.7 fl. oz. 50 ml

INGREDIENTS AND APPEARANCE

SPF 30 FACE MOISTURIZER 
avobenzone, homosalate, octinoxate, octisalate, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53634-255
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.75   in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	5   in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DIMETHICONE (UNII: 92RU3N3Y1O)
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
GLYCERIN (UNII: PDC6A3C0OX)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PEG-12 DIMETHICONE (UNII: ZEL54N6W95)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PANTHENOL (UNII: WV9CM0O67Z)
ALLANTOIN (UNII: 344S277G0Z)
ALOE FEROX LEAF (UNII: 0D145J8EME)
SHEANUT OIL (UNII: O88E196QRF)
EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
XANTHAN GUM (UNII: TTV12P4NEE)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CALCIUM PANTOTHENATE (UNII: 568ET80C3D)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CHLORPHENESIN (UNII: I670DAL4SZ)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PEG-40 STEARATE (UNII: ECU18C66Q7)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53634-255-02	1 in 1 CARTON	12/05/2017
1	NDC: 53634-255-01	50 mL in 1 JAR; 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	12/05/2017

Labeler - Malin and Goetz Inc (138615930)

Establishment
Name	Address	ID/FEI	Business Operations
Milbar Laboratories,Inc.		195556790	manufacture(53634-255)