SPORT SUNBLOCK- octinoxate and titanium dioxide lotion

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

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Active ingredient:
Octyl Methoxycinnamate 7%, Titanium Dioxide 2.8%
Available from:
Kareway Product, Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Sunscreen Sunscreen helps prevent sunburn
Authorization status:
OTC monograph not final
Authorization number:
67510-0083-5

SPORT SUNBLOCK- octinoxate and titanium dioxide lotion

Kareway Product, 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

Octyl Methoxycinnamate 7%

Titanium Dioxide 2.8%

Purpos e

Sunscreen

Sunscreen

Us e

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 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.

If product is swallowed, get medical help or call a Poison Control Center right away.

Directions

apply liberally 15 minutes before sun exposure

reapply:

after 40 minutes of swimming or sweating

immediately after towel drying

at least every 2 hours

children under 6 months: Ask a doctor

Other information

protect this product from excessive heat and direct sun

Inactive Ingredients

Water, Glycerin, Stearic acid,

Cetearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate,

Phenoxyethanol, Triethanolamine, Dimethicone, Acrylates/

C10-30 alkyl acrylate crosspolymer, Chlorphenesin,

Lavandula Angustifolia (Lavender) Extract, Salvia Sclarea

(Clary) Extract, Hyacinthus Orientalis Extract, Chamomilla

Recutita (Matricaria) Flower/Leaf Extract, Borago officinalis

Extract, Centaurea cyanus flower Extract, Butylene Glycol,

1,2- Hexanediol, Ethylhexylglycerin, Disodium EDTA, Fragrance

Package label

Sport Sunscreen

SPORT SUNBLOCK

octinoxate and titanium dioxide lotion

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 7510 -0 0 8 3

Route of Administration

TOPICAL

Kareway Product, Inc.

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

OCTINOXATE

7 g in 10 0 mL

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP) (TITANIUM DIOXIDE - UNII:15FIX9 V2JP)

TITANIUM DIOXIDE

2.8 g in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

CETO STEARYL ALCO HO L (UNII: 2DMT128 M1S)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

CARBO MER CO PO LYMER TYPE A ( ALLYL PENTAERYTHRITO L CRO SSLINKED) (UNII: 71DD5V9 9 5L)

GLYCERIN (UNII: PDC6 A3C0 OX)

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

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

CHLO RPHENESIN (UNII: I6 70 DAL4SZ)

BUTYLENE GLYCO L (UNII: 3XUS8 5K0 RA)

1,2 -HEXANEDIO L (UNII: TR0 46 Y3K1G)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

TRO LAMINE (UNII: 9 O3K9 3S3TK)

WATER (UNII: 0 59 QF0 KO0 R)

ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

EDETATE DISO DIUM ANHYDRO US (UNII: 8 NLQ36 F6 MM)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 7510 -0 0 8 3-5

10 0 mL in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

10 /27/20 11

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

10 /27/20 11

Labeler -

Kareway Product, Inc. (121840057)

Revised: 10/2019

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