Drug Facts

Drug Facts
SPL v16
SPL
SPL Set ID c7526b69-d059-499a-9134-3a1f5d0471b3
Route
TOPICAL
Published
Effective Date 2017-05-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (2.5 g) Homosalate (8 g) Octisalate (5 g) Octocrylene (2.2 g)
Inactive Ingredients
Yellow Wax Hydrogenated Avocado Oil Shea Butter Avocado Oil Jojoba Oil Dimethicone Ethylhexyl Palmitate Hydrogenated Polydecene (550 Mw) Dunaliella Salina Palmitoyl Tripeptide-1 Tetrahexyldecyl Ascorbate .alpha.-tocopherol Acetate Vitamin A Palmitate Tea Tree Oil Tribehenin Sorbitan Isostearate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-05-01

Description

Avobenzone 2.5% Homosalate 8% Octisalate 5% Octocrylene 2.2%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 2.5% Homosalate 8% Octisalate 5% Octocrylene 2.2%

Uses
  • Helps prevent sunburn
  • If used as directed with other sun protection measures (See ), decreases the risk of skin cancer and early skin aging caused by the sun Directions
Section 50565-1

If product is swallowed, get medical help or contact Poison Control Center right away. Keep out of reach of Children

Section 50566-9

if rash occurs. Stop use and ask a doctor

Section 50567-7

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

Section 50570-1

on damaged or broken skin. Do not use

Directions
  • Apply liberally and evenly, covering lips completely. Apply liberally 15 minutes before sun exposure
  • Use a water-resistant sunscreen if swimming or sweating
  • Reapply at least every 2 hours
  • 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 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
  • Children under 6 months: Ask a doctor
Other Information

Protect this product from excessive heat and sun.

Active Ingredients

Avobenzone 2.5%

Homosalate 8%

Octisalate 5%

Octocrylene 2.2%

Inactive Ingredients

Beeswax, Hydrogenated Avocado Oil, Butyrospermum Parkii (Shea Butter), Persea Gratissima (Avocado) Oil, Simmondsia Chinesis (Jojoba) Seed Oil, Acacia Decurrens / Jojoba / Sunflower Seed Wax / Polyglyceryl-3 Esters, Sunflower (Helianthus Annuus) Seed Oil Unsaponifiables, Dimethicone, Fragrance, Ethylhexyl Palmitate, Hydrogenated Polydecene, Dunaliella Salina Extract, Palmitoyl Tripeptide-1, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Retinyl Palmitate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Tribehenin, Sorbitan Isosterate.

Principal Display Panel Essentials Lip Shield Outer Label

RODAN+FIELDS ®

ESSENTIALS

Lip Shield

BROAD SPECTRUM SPF 25



Contains 2 Tubes

4.25 g/.15 Oz. Ea.

Principal Display Panel Essentials Lip Shield Primary Label

RODAN+FIELDS ®

ESSENTIALS


Structured Label Content

Uses
  • Helps prevent sunburn
  • If used as directed with other sun protection measures (See ), decreases the risk of skin cancer and early skin aging caused by the sun Directions
Section 50565-1 (50565-1)

If product is swallowed, get medical help or contact Poison Control Center right away. Keep out of reach of Children

Section 50566-9 (50566-9)

if rash occurs. Stop use and ask a doctor

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)

on damaged or broken skin. Do not use

Purpose

Sunscreen

Directions
  • Apply liberally and evenly, covering lips completely. Apply liberally 15 minutes before sun exposure
  • Use a water-resistant sunscreen if swimming or sweating
  • Reapply at least every 2 hours
  • 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 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
  • Children under 6 months: Ask a doctor
Other Information (Other information)

Protect this product from excessive heat and sun.

Active Ingredients

Avobenzone 2.5%

Homosalate 8%

Octisalate 5%

Octocrylene 2.2%

Inactive Ingredients (Inactive ingredients)

Beeswax, Hydrogenated Avocado Oil, Butyrospermum Parkii (Shea Butter), Persea Gratissima (Avocado) Oil, Simmondsia Chinesis (Jojoba) Seed Oil, Acacia Decurrens / Jojoba / Sunflower Seed Wax / Polyglyceryl-3 Esters, Sunflower (Helianthus Annuus) Seed Oil Unsaponifiables, Dimethicone, Fragrance, Ethylhexyl Palmitate, Hydrogenated Polydecene, Dunaliella Salina Extract, Palmitoyl Tripeptide-1, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Retinyl Palmitate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Tribehenin, Sorbitan Isosterate.

Principal Display Panel Essentials Lip Shield Outer Label (Principal Display Panel - Essentials Lip Shield Outer Label)

RODAN+FIELDS ®

ESSENTIALS

Lip Shield

BROAD SPECTRUM SPF 25



Contains 2 Tubes

4.25 g/.15 Oz. Ea.

Principal Display Panel Essentials Lip Shield Primary Label (Principal Display Panel - Essentials Lip Shield Primary Label)

RODAN+FIELDS ®

ESSENTIALS


Advanced Ingredient Data


Raw Label Data

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