TANNING SUNSCREEN SPF 4 DAYLOGIC- octinoxate 6% lotion

Tanning Sunscreen SPF 4 by

Drug Labeling and Warnings

Tanning Sunscreen SPF 4 by is a Otc medication manufactured, distributed, or labeled by Rite Aid, Product Quest Mfg. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients                                                            Purpose
Octinoxate 6%.................................................................Sunscreen

PURPOSE

INDICATIONS & USAGE

Uses helps prevent sunburn

WARNINGS

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 prevent 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. Rinse with water to
remove.
Stop use and ask a doctor if rash occurs

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Directions
apply liberally 15 minutes before sun exposure
reapply: after 80 minutes of swimming or sweating
immediately after towel drying at least every 2 hours
children under 6 months: Ask a doctor

OTHER SAFETY INFORMATION

Other information
protect this product from excessive heat and direct sun.

INACTIVE INGREDIENT

Inactive ingredients
Water, Mineral Oil, Polyethylene, Stearic Acid, Glyceryl Stearate SE,
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis
Leaf Juice, Ammonium Hydroxide, Ascorbyl Palmitate, Cetyl Alcohol,
Diazolidinyl Urea, Disodium EDTA, Glycerin, Magnesium Aluminum
Silicate, Methylparaben, PEG-40 Castor Oil, Phospholipids,
Propylparaben, Retinyl Palmitate, Sorbitol, Theobroma Cacao (Cocoa)
Seed Butter, Tocopheryl Acetate, Triethanolamine, Fragrance.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TANNING SUNSCREEN SPF 4  DAYLOGIC
octinoxate 6% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-7788
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AMMONIA (UNII: 5138Q19F1X)
Ascorbyl Palmitate (UNII: QN83US2B0N)
Cetyl Alcohol (UNII: 936JST6JCN)
Diazolidinyl Urea (UNII: H5RIZ3MPW4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
Glycerin (UNII: PDC6A3C0OX)
Glyceryl Stearate SE (UNII: FCZ5MH785I)
Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)
Methylparaben (UNII: A2I8C7HI9T)
Mineral Oil (UNII: T5L8T28FGP)
PEG-40 Castor Oil (UNII: 4ERD2076EF)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
Propylparaben (UNII: Z8IX2SC1OH)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
Sorbitol (UNII: 506T60A25R)
Stearic Acid (UNII: 4ELV7Z65AP)
COCOA BUTTER (UNII: 512OYT1CRR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11822-7788-6	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/10/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/10/2016

Labeler - Rite Aid (014578892)

Registrant - Product Quest Mfg (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg		927768135	manufacture(11822-7788) , label(11822-7788)