CARDINAL HEALTH LEADER GENERAL PROTECTION SUNSCREEN SPF 30- avobenzone, homosalate, octisalate, octocrylene spray

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

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Active ingredient:
Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 2.0%
Available from:
CARDINAL HEALTH, INC.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Sunscreen • helps prevent sunburn • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun • on damaged or broken skin. • rash occurs.
Authorization status:
OTC monograph not final
Authorization number:
70000-0073-1

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CARDINAL HEALTH LEADER GENERAL PROTECTION SUNSCREEN SPF 30-

avobenzone, homosalate, octisalate, octocrylene spray

CARDINAL HEALTH, 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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Cardinal Health Leader General Protection Sunscreen SPF 30 Clear Continious Spray

Active ingredients

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 2.0%

Purpos e

Sunscreen

Us es

helps prevent sunburn if used as directed with other sun protection measures (see Directions),

decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Flammable:

do not use near heat, flame or while smoking

avoid long term storage above 104°F (40°C)

Do not use

on damaged or broken skin.

When using this product

keep out of eyes. Rinse with water to remove.

Keep away from face to avoid breathing it.

do not puncture or incinerate.Contents under pressure.

do not store at temperatures above 120° F.

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

Spray liberally and spread evenly by hand 15 minutes before sun exposure

Hold can 4-6 inches away from the skin to apply

Do not spray directly into face. Spray into hands then apply to face

Do not apply in windy conditions

Use in a well-ventilated area

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

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin

aging. To decrease this risk, regularly 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 a.m. - 2 p.m.

wear long-sleeved shirts, pants, hats, and sunglasses

Other information

protect the product in this container from excessive heat and direct sun

may stain or damage some fabrics, materials or surfaces

Inactive ingredients

SD alcohol 40-B, butyloctyl salicylate, acrylates/octylacrylamide copolymer, panthenol, tocopherol,

fragrance, stearoxytrimethylsilane, caprylic/capric triglyceride, glycerin

Label

Cardinal Health Leader General Protection Sunscreen SPF 30 Clear Continious Spray

5.5 oz (156 g)

NDC 70000-0073-1

CARDINAL HEALTH LEADER GENERAL PROTECTION SUNSCREEN SPF 30

avobenzone, homosalate, octisalate, octocrylene spray

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:70 0 0 0 -0 0 73

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

AVO BENZO NE (UNII: G6 3QQF2NOX) (AVOBENZONE - UNII:G6 3QQF2NOX)

AVOBENZONE

30 mg in 1 g

HO MO SALATE (UNII: V0 6 SV4M9 5S) (HOMOSALATE - UNII:V0 6 SV4M9 5S)

HOMOSALATE

10 0 mg in 1 g

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

OCTOCRYLENE

20 mg in 1 g

CARDINAL HEALTH, INC.

O CTISALATE (UNII: 4X49 Y0 59 6 W) (OCTISALATE - UNII:4X49 Y0 59 6 W)

OCTISALATE

50 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

PANTHENO L (UNII: WV9 CM0 O6 7Z)

GLYCERIN (UNII: PDC6 A3C0 OX)

MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9 H2L21V7U)

BUTYLO CTYL SALICYLATE (UNII: 2EH13UN8 D3)

ACRYLATE/ISO BUTYL METHACRYLATE/N-TERT-O CTYLACRYLAMIDE CO PO LYMER ( 7 50 0 0 MW) (UNII:

JU3XHR8 VWK)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

STEARO XYTRIMETHYLSILANE (UNII: 9 8 6 2TW9 4B2)

.ALPHA.-TO CO PHERO L, DL- (UNII: 7QWA1RIO0 1)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:70 0 0 0 -0 0 73-1

156 g in 1 CAN; Type 0 : No t a Co mbinatio n Pro duct

12/0 9 /20 20

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

12/0 9 /20 20

Labeler -

CARDINAL HEALT H, INC. (097537435)

Revised: 12/2020

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