DAILY MOISTURIZER BROAD-SPECTRUM SPF 30- avobenzone, octinoxate, octisalate lotion

Daily Moisturizer Broad-Spectrum SPF 30 by

Drug Labeling and Warnings

Daily Moisturizer Broad-Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by Mana Products. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 3.00%

Octinoxate 7.50%

Octisalate 5.0%

Use

Helps prevent sunburn. If used as directed with other sun protection measures, helps decrease the risk of skin cancer and early signs of 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 ask a docor if rash occurs
• Keep out of reach of children. If swalled, get medical help or contact a Poison Control Center right away.

Directions

• Apply liberally 15 minutes before sun exposure
• Use water resistant sunscreen if swimming or sweathing
• Reapply at least every 2 hours
• Children under 6 months: ask a doctor
• Sun Protection Measures: Spending time in the sun decreases risk of skin cancer and early again. To decrease this risk, regulaory 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 10:00 am - 2:00 pm. Wear long sleeved shirts, pants, hats and sunglasses.

Inactive Ingredients

Water (Aqua, Eau), Octyldodecyl Neopentanoate, C12-15 Alkyl Benzoate, Butylene Glycol, Mica, Titanium Dioxide (CI 77891), Glycerin, Simmondsia Chinensis Seed Oil, Butyrospermum Parkii (Shea) Butter, Hexapeptide-33, Stearic Acid, Behenyl Alcohol, Glyceryl Stearate, Lecithin,Myristyl Alcohol, Lauryl Alcohol, Cetyl Alcohol, Palmitic Acid, Cetearyl Alcohol, Coco-Glucoside, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Prunus Armeniaca Kernel Oil, Carica Papaya Fruit Extract, Cymbopogon Schoenanthus Extract, Aesculus Hippocastanum Seed Extract, Aloe Barbadensis Leaf Extract, Polysorbate 20, Sorbitan Laurate, Propylene Glycol Stearate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Carbomer, Sodium Hydroxide, Propylene Glycol Laurate, Ethylhexylglycerin, Disodium Edta, Phenoxyethanol, o-Cymen-5-Ol, Fragrance (Parfum), Benzyl Alcohol, Benzyl Salicylate, Butylphenyl Methylpropional, d-Limonene

Other Information

Protect this product form excessive heat and direct sun

Principal Display Panel

INGREDIENTS AND APPEARANCE

DAILY MOISTURIZER BROAD-SPECTRUM SPF 30 
avobenzone, octinoxate, octisalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59735-130
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 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
GLYCERIN (UNII: PDC6A3C0OX)
SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)
SHEA BUTTER (UNII: K49155WL9Y)
STEARIC ACID (UNII: 4ELV7Z65AP)
BEHENYL BENZOATE (UNII: DQG8119XKJ)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
MYRISTYL ALCOHOL (UNII: V42034O9PU)
LAURYL ALCOHOL (UNII: 178A96NLP2)
CETYL ALCOHOL (UNII: 936JST6JCN)
PALMITIC ACID (UNII: 2V16EO95H1)
COCO GLUCOSIDE (UNII: ICS790225B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
PRUNUS ARMENIACA LEAF (UNII: 0X5YG5R83N)
CARICA PAPAYA LEAF (UNII: 66J7636Z2I)
CYMBOPOGON SCHOENANTHUS OIL (UNII: XE7K568ILO)
AESCULUS HIPPOCASTANUM LEAF (UNII: Z49U891FNQ)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SORBITAN OLIVATE (UNII: MDL271E3GR)
PROPYLENE GLYCOL STEARATE (UNII: MZM1I680W0)
CARBOMER 940 (UNII: 4Q93RCW27E)
SODIUM HYDRIDE (UNII: 23J3BHR95O)
PROPYLENE GLYCOL LAURATES (UNII: 40KT317HGP)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
O-CYMEN-5-OL (UNII: H41B6Q1I9L)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
LIMONENE, DL- (UNII: 9MC3I34447)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59735-130-01	50 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/27/2014

Labeler - Mana Products (078870292)