Tender Moments Baby Sunscreen

Tender Moments Baby Sunscreen
SPL v4
SPL
SPL Set ID d6765958-7b61-4393-95e8-db8212bad93d
Route
TOPICAL
Published
Effective Date 2013-09-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Homosalate (10 g) Octisalate (5 g) Octocrylene (7 g) Oxybenzone
Inactive Ingredients
Allantoin Aluminum Starch Octenylsuccinate Arachidyl Alcohol Arachidyl Glucoside Oat Docosanol Butylene Glycol Chlorphenesin Cyclomethicone 5 Edetate Disodium Ethylhexylglycerin Glyceryl Monostearate Lauroyl Lysine Methylisothiazolinone Panthenol Peg-100 Stearate Sodium Hydroxide .alpha.-tocopherol Acetate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-09-30

Description

Active ingredients     Purpose Avobenzone 3%       Sunscreen Homosalate 10%      Sunscreen Octisalate 5%           Sunscreen Octocrylene 7%        Sunscreen Oxybenzone 5%       Sunscreen     


Medication Information

Warnings and Precautions

Warnings

For external use only

When using this product keep out of eyes. Rinse with water to remove.

Indications and Usage

Do not use on damaged or broken skin

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 sun protection measures including:

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

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

Description

Active ingredients     Purpose Avobenzone 3%       Sunscreen Homosalate 10%      Sunscreen Octisalate 5%           Sunscreen Octocrylene 7%        Sunscreen Oxybenzone 5%       Sunscreen     

Section 50565-1

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

Section 51727-6

Inactive ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/Dimethicone Copolymer, Allantoin, Aluminum Starch Octenylsuccinate, Arachidyl Alcohol, Arachidyl Glucoside, Avena Sativa (Oat) Kernel Extract, Behenyl Alcohol, Butylene Glycol, Chlorphenesin, Cyclopentasiloxane, Disodium EDTA, Ethylhexylglycerin, Fragrance/Parfum, Glyceryl Stearate, Lauroyl Lysine, Methylisothiazolinone, Panthenol, PEG-100 Stearate, Sodium Hydroxide, Styrene/Acrylates Copolymer, Tocopheryl Acetate, Water/Aqua.

Section 51945-4

Jafra

Tender Moments

Baby Sunscreen Broad Spectrum SPF 50

50 ml 1.7 Fl Oz

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 by the sun.

Section 55106-9

Active ingredients     Purpose

Avobenzone 3%       Sunscreen

Homosalate 10%      Sunscreen

Octisalate 5%           Sunscreen

Octocrylene 7%        Sunscreen

Oxybenzone 5%       Sunscreen     


Structured Label Content

Indications and Usage (34067-9)

Do not use on damaged or broken skin

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 sun protection measures including:

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

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

Warnings and Precautions (34071-1)

Warnings

For external use only

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

Section 51727-6 (51727-6)

Inactive ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/Dimethicone Copolymer, Allantoin, Aluminum Starch Octenylsuccinate, Arachidyl Alcohol, Arachidyl Glucoside, Avena Sativa (Oat) Kernel Extract, Behenyl Alcohol, Butylene Glycol, Chlorphenesin, Cyclopentasiloxane, Disodium EDTA, Ethylhexylglycerin, Fragrance/Parfum, Glyceryl Stearate, Lauroyl Lysine, Methylisothiazolinone, Panthenol, PEG-100 Stearate, Sodium Hydroxide, Styrene/Acrylates Copolymer, Tocopheryl Acetate, Water/Aqua.

Section 51945-4 (51945-4)

Jafra

Tender Moments

Baby Sunscreen Broad Spectrum SPF 50

50 ml 1.7 Fl Oz

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 by the sun.

Section 55106-9 (55106-9)

Active ingredients     Purpose

Avobenzone 3%       Sunscreen

Homosalate 10%      Sunscreen

Octisalate 5%           Sunscreen

Octocrylene 7%        Sunscreen

Oxybenzone 5%       Sunscreen     


Advanced Ingredient Data


Raw Label Data

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