Hand Complex Broad Spectrum Spf 15

Hand Complex Broad Spectrum Spf 15
SPL v4
SPL
SPL Set ID aa7a30f0-4be0-40b0-8096-5ecb7bb39186
Route
TOPICAL
Published
Effective Date 2013-02-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Octinoxate (7.5 g) Octisalate (5 g) Oxybenzone (2 g)
Inactive Ingredients
Water Polyacrylamide (10000 Mw) C13-14 Isoparaffin Laureth-7 Glyceryl Monostearate Glycerin Panthenol .alpha.-tocopherol Acetate Ethylhexylglycerin Methylisothiazolinone Royal Jelly Helianthus Annuus Sprout Egg Phospholipids Peg-4 Laurate Iodopropynyl Butylcarbamate Edetate Trisodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-02-13

Description

Active Ingredients Purpose Avobenzone 3% Sunscreen Octinoxate 7.5% Sunscreen Octisalate 5% Sunscreen Oxybenzone 2% Sunscreen


Medication Information

Warnings and Precautions

Warnings

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.

Indications and Usage

Stop use and ask a doctor if rash occurs

Dosage and Administration

Directions

apply liberally 15 minutes before sun exposure

use a water resistant sunscreen if swimming or sweating

reapply at least every 2 hours

children under 6 months: 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 sunscreen measures including:

limit time in the sun, especially from 10a.m.- 2 p.m.

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

Description

Active Ingredients Purpose Avobenzone 3% Sunscreen Octinoxate 7.5% Sunscreen Octisalate 5% Sunscreen Oxybenzone 2% Sunscreen

Section 50565-1

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

Section 51727-6

Inactive

Water/Aqua, Polyglyceryl-3 Methylglucose Distearate, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Glyceryl Stearate, Glycerin, Panthenol, Tocopheryl Acetate, Withania Somnifera (Winter Cherry) Extract, Nelumbo Nucifera (Lotus) Extract, Fragrance/Parfum, Ethylhexyglycerin, Methylisothiazolinone, Royal Jelly, Helianthus Annuus (Sunflower) Sprout Extract, Lecithin, Hydrolyzed Myrtus Communis Leaf Extract, PEG-4 Laurate, Iodopropynyl Butylcarbamate, Trisodium EDTA

Section 51945-4

Jafra

Royal Jelly

with/con

Cellspan Complex

Hand Complex Broad Spectrum SPF 15

Cont. Net. 75 ml 2.5 fl oz (US)

Section 55105-1

Uses

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.

Section 55106-9

Active Ingredients Purpose

Avobenzone 3% Sunscreen

Octinoxate 7.5% Sunscreen

Octisalate 5% Sunscreen

Oxybenzone 2% Sunscreen


Structured Label Content

Indications and Usage (34067-9)

Stop use and ask a doctor if rash occurs

Dosage and Administration (34068-7)

Directions

apply liberally 15 minutes before sun exposure

use a water resistant sunscreen if swimming or sweating

reapply at least every 2 hours

children under 6 months: 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 sunscreen measures including:

limit time in the sun, especially from 10a.m.- 2 p.m.

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

Warnings and Precautions (34071-1)

Warnings

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.

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Inactive

Water/Aqua, Polyglyceryl-3 Methylglucose Distearate, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Glyceryl Stearate, Glycerin, Panthenol, Tocopheryl Acetate, Withania Somnifera (Winter Cherry) Extract, Nelumbo Nucifera (Lotus) Extract, Fragrance/Parfum, Ethylhexyglycerin, Methylisothiazolinone, Royal Jelly, Helianthus Annuus (Sunflower) Sprout Extract, Lecithin, Hydrolyzed Myrtus Communis Leaf Extract, PEG-4 Laurate, Iodopropynyl Butylcarbamate, Trisodium EDTA

Section 51945-4 (51945-4)

Jafra

Royal Jelly

with/con

Cellspan Complex

Hand Complex Broad Spectrum SPF 15

Cont. Net. 75 ml 2.5 fl oz (US)

Section 55105-1 (55105-1)

Uses

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.

Section 55106-9 (55106-9)

Active Ingredients Purpose

Avobenzone 3% Sunscreen

Octinoxate 7.5% Sunscreen

Octisalate 5% Sunscreen

Oxybenzone 2% Sunscreen


Advanced Ingredient Data


Raw Label Data

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