RITE AID ESSENTIAL DEFENSE SPF 45- avobenzone homosalate octisalate octocrylene oxybenzone lotion
RITE AID CORPORATION

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active Ingredients

Avobenzone 2.0 %

Homosalate 12.0%

Octinoxate 7.5%

Octisalate 5.0%

Oxybenzone 6.0%

Purpose

Sunscreen

Uses

helps prevent sunburn
higher SPF gives more sunburn protection
retains SPF after 80 minutes of activity in the water

Warnings

For external use only

When using this product

keep out of eyes. Rinse with water to remove.

stop use and ask a doctor if

rash or irritation develops and lasts

Keep out of reach of children.

If swallowed get medical help or contact a Poison Control Center right away.

Other Information

may stain some materials

Directions

shake well
apply generously before sun exposure and as needed
children under 6 months of age:ask a doctor
reapply frequently and after towel drying, swimming or perspiring.

Inactive Ingredients

Water, Methylpropanediol, VP/Eicosene Copolymer, Sorbitan Isostearate, Cetyl Alcohol, Triethanolamine, Isostearic Acid, Stearic Acid, Cetyl Phosphate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Glycerin, Methylparaben, Chlorphenesin, Fragrance, Benzoic Acid, Phenoxyethanol, Disodium EDTA, Bisabolol, Retinyl Palmitate, Ascorbic Acid, Tocopheryl Acetate, PEG-8 Dimethicone, Sodium Propoxyhydroxypropyl Thiosulfate Silica, Octyldodecanol, Silica.

Principal Display Panel

RITE
AID
Essential Defence
OIL FREE SUNSCREEN LOTION
SPF
45
Broad Spectrum Protection
RECOMMENDED
SKIN CANCER
FOUNDATION
won't clog pores
very water resistance
Vitamins A, C and E
4 FL. OZ. (118 mL)

RITE AID ESSENTIAL DEFENSE SPF 45
avobenzone homosalate octisalate octocrylene oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11822-9004
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	12 g in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	6 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CETYL ALCOHOL (UNII: 936JST6JCN)
TROLAMINE (UNII: 9O3K93S3TK)
ISOSTEARIC ACID (UNII: X33R8U0062)
STEARIC ACID (UNII: 4ELV7Z65AP)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
CETYL PHOSPHATE (UNII: VT07D6X67O)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CHLORPHENESIN (UNII: I670DAL4SZ)
BENZOIC ACID (UNII: 8SKN0B0MIM)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
LEVOMENOL (UNII: 24WE03BX2T)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
PEG-8 DIMETHICONE (UNII: GIA7T764OD)
OCTYLDODECANOL (UNII: 461N1O614Y)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11822-9004-3	113 g in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	11/21/2012

Labeler - RITE AID CORPORATION (014578892)