Tender Moments Baby Sunscreen Broad Spectrum Spf 50+ Water Resistant (40 Minutes)

Tender Moments Baby Sunscreen Broad Spectrum Spf 50+ Water Resistant (40 Minutes)
SPL v6
SPL
SPL Set ID c3bacceb-63a8-098c-e053-2995a90acd64
Route
TOPICAL
Published
Effective Date 2024-12-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Homosalate (10 g) Octisalate (5 g) Octocrylene
Inactive Ingredients
Polyester-8 (1400 Mw, Cyanodiphenylpropenoyl Capped) Vinylpyrrolidone/eicosene Copolymer Hexylene Glycol Mica Phenoxyethanol Caprylyl Glycol Water Cetyl Alcohol Dicaprylyl Carbonate Ethylhexyl Methoxycrylene Ethylhexylglycerin Silicon Dioxide Levomenol Shea Butter Aloe Vera Leaf Carbomer Copolymer Type B (allyl Pentaerythritol Crosslinked) Panthenol .alpha.-tocopherol Acetate Chlorphenesin Edetate Disodium Arginine Glyceryl Monostearate Peg-100 Stearate Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-06-10 Until 2024-12-30
Description

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

Stop use and ask a doctor ifrash occurs.

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

Indications and Usage

Dosage and Administration

Directions

  • apply liberally and evenly 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 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
Description

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

Section 42229-5

Questions?Call 1-800-551-2345 or visit www.jafra.com

Section 50565-1

Section 51727-6

Inactive ingredients

Water, Glycerin, Polyester-8, Glyceryl Stearate, PEG-100 Stearate, Styrene/Acrylates Copolymer, Cetyl Alcohol, Dicaprylyl Carbonate, VP/Eicosene Copolymer, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Ethylhexyl Methoxycrylene, Mica, Silica, Bisabolol, Butyrospermum Parkii (Shea) Butter, Aloe Barbadensis Leaf Juice, Arginine, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Panthenol, Tocopheryl Acetate, Chlorphenesin, Disodium EDTA

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

Homosalate 10% Sunscreen

Octisalate 5% Sunscreen

Octocrylene 10% Sunscreen

Product Label

Other Information
  • protect this product from excessive heat and direct sun

Structured Label Content

Indications and Usage (34067-9)

Dosage and Administration (34068-7)

Directions

  • apply liberally and evenly 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 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
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

Stop use and ask a doctor ifrash occurs.

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

Section 42229-5 (42229-5)

Questions?Call 1-800-551-2345 or visit www.jafra.com

Section 50565-1 (50565-1)

Section 51727-6 (51727-6)

Inactive ingredients

Water, Glycerin, Polyester-8, Glyceryl Stearate, PEG-100 Stearate, Styrene/Acrylates Copolymer, Cetyl Alcohol, Dicaprylyl Carbonate, VP/Eicosene Copolymer, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Ethylhexyl Methoxycrylene, Mica, Silica, Bisabolol, Butyrospermum Parkii (Shea) Butter, Aloe Barbadensis Leaf Juice, Arginine, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Panthenol, Tocopheryl Acetate, Chlorphenesin, Disodium EDTA

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

Homosalate 10% Sunscreen

Octisalate 5% Sunscreen

Octocrylene 10% Sunscreen

Product Label (Product label)

Other Information (Other information)
  • protect this product from excessive heat and direct sun

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:11.986701 · Updated: 2026-03-14T23:06:40.095610