MEIJER TROPICAL SPF 4- octocrylene, oxybenzone lotion

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Octocrylene 1.0 Oxybenzone 0.5
Available from:
Meijer Distribution Inc
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Sunscreen helps prevent sunburn if rash occurs
Authorization status:
OTC monograph not final
Authorization number:
41250-013-57

MEIJER TROPICAL SPF 4- octocrylene, oxybenzone lotion

Meijer Distribution Inc

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

Octocrylene 1.0

Oxybenzone 0.5

Purpos e

Sunscreen

Us es

helps prevent sunburn

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 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

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

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 of age: Ask a doctor

Inactive Ingredients

Water, Petrolatum, Diisopropyl Adipate, Propylene Glycol, Polyglyceryl-3 Methylglucose Distearate,

Cetyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer,

Triethanolamine, Benzyl Alcohol, Theobroma Cacao (Cocoa) Seed Butter, Butyrospermum Parkii

(Shea) Butter, Disodium EDTA, PEG-8 Dimethicone, Aloe Barbadensis Leaf Juice Powder,

Octyldodecanol, Retinyl Palmitate, Silica, Tocopheryl Acetate, Ascorbic Acid, Sodium

Propoxyhydroxypropyl Thiosulfate Silica, Methylparaben, Propylparaben, Quaternium-15, Fragrance.

Other Information

protect this product from excessive heat and direct sun

Principle Display Panel

MEIJER TROPICAL SPF 4

octocrylene, oxybenzone lotion

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:41250 -0 13

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

O CTO CRYLENE (UNII: 5A6 8 WGF6 WM) (OCTOCRYLENE - UNII:5A6 8 WGF6 WM)

OCTOCRYLENE

1 mL in 10 0 mL

O XYBENZO NE (UNII: 9 5OOS7VE0 Y) (OXYBENZONE - UNII:9 5OOS7VE0 Y)

OXYBENZONE

0 .5 mL in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

PETRO LATUM (UNII: 4T6 H12BN9 U)

DIISO PRO PYL ADIPATE (UNII: P7E6 YFV72X)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

PEG-10 0 STEARATE (UNII: YD0 1N19 9 9 R)

CARBO MER INTERPO LYMER TYPE A ( 550 0 0 CPS) (UNII: 59 TL3WG5CO)

TRO LAMINE (UNII: 9 O3K9 3S3TK)

BENZYL ALCO HO L (UNII: LKG8 49 4WBH)

CO CO A BUTTER (UNII: 512OYT1CRR)

SHEA BUTTER (UNII: K49 155WL9 Y)

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

PEG-8 DIMETHICO NE (UNII: GIA7T76 4OD)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

O CTYLDO DECANO L (UNII: 46 1N1O6 14Y)

VITAMIN A PALMITATE (UNII: 1D1K0 N0 VVC)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

ASCO RBIC ACID (UNII: PQ6 CK8 PD0 R)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

Q UATERNIUM-15 (UNII: E40 U0 3LEM0 )

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:41250 -0 13-57

29 5 mL in 1 BOTTLE

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 1/0 1/20 12

Meijer Distribution Inc

Labeler -

Meijer Distribution Inc (006959555)

Revised: 1/2012

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