Impact Melanoma Spf 30

Impact Melanoma Spf 30
SPL v2
SPL
SPL Set ID f953302e-f712-129a-e053-6294a90ab9a8
Route
TOPICAL
Published
Effective Date 2023-04-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (17.5 g) Octinoxate (70 g) Octisalate (10 g) Titanium Dioxide (12.5 g)
Inactive Ingredients
Malva Sylvestris Flower Asian Ginseng Glycerin Matricaria Recutita Flowering Top Comfrey Leaf Sorbitol Polyoxyl 20 Cetostearyl Ether Cetostearyl Alcohol Dimethicone 350 Cetyl Alcohol Carbomer 934 Water Isocetyl Stearate Alpha-tocopherol Acetate Trolamine Aloe Vera Leaf Polyester-7 Neopentyl Glycol Diheptanoate Caprylyl Glycol Phenoxyethanol Hexylene Glycol Stearic Acid Calendula Officinalis Flower

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-04-17

Description

IMPACT MELANOMA SPF 30 sunscreen is broad spectrum, water resistant (80 minutes), free of parabens and made for all skin types

Purpose

Octyl Methoxy Cinnamate 7.00% Sunscreen Titanium Dioxide 1.25% Sunscreen Zinc Oxide 1.25% Sunscreen Octyl Salicylate 1.00% Sunscreen


Medication Information

Purpose

Octyl Methoxy Cinnamate 7.00% Sunscreen

Titanium Dioxide 1.25% Sunscreen

Zinc Oxide 1.25% Sunscreen

Octyl Salicylate 1.00% Sunscreen

Description

IMPACT MELANOMA SPF 30 sunscreen is broad spectrum, water resistant (80 minutes), free of parabens and made for all skin types

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 43683-2

Minor word changes in Administration such as apply liberally rather than apply generously

No Major changes in Uses section

Section 50565-1

Keep out of reach of children.

Section 51945-4

LABEL FOR IMPACT MELANOMA SPF

Section 69718-5

IMPACT MELANOMA SPF 30

sunscreen is broad spectrum, water

resistant (80 minutes), free of parabens

and made for all skin types

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 consult physician if irritation or rash develops.
  • Keep out of reach of children.
  • If product is swallowed, get medical attention or contact poison control center immediately.
Directions
  • Apply liberally 15 minutes before sun exposure
  • Reapply after 80 minutes of swimming or sweating.
  • reapply immediately after towel drying.
  • 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 sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including:
  • Limited time in the sun, especially between 10am and 2pm.
  • Wear long sleeve shirts, pants, hats and sunglasses.
  • For children under 6 months, consult a physician.
Other Ingredients

Aloe Barbadensis (Aloe Vera) Leaf Juice, Calendula Officinalis (Marigold) Flower Extract, Caprylyl Glycol, Carbopol, Ceteareth-20, Cetearyl Alcohol, Deionized Water, Dimethicone, Glycerin, Hexylene Glycol, Isocetyl Stearate, Malva Sylvestris (Mallow) Flower Extract, Panax Ginseng Root Extract, Phenoxyethanol, Polyester-7, Neopentyl Glycol, Diheptanoate, Sorbitol, Stearic Acid,

Symphytum Officinale (Comfrey) Leaf Extract, Triethanolamine, Tocopheryl Acetate (Vitamin E)

Other Information
  • Protect this product from excessive heat and direct sunlight.
  • May stain some fabrics.
Active Ingredients

Octyl Methoxy Cinnamate 7.00% Sunscreen

Titanium Dioxide 1.25% Sunscreen

Zinc Oxide 1.25% Sunscreen

Octyl Salicylate 1.00% Sunscreen

Questions Or Comments?

Visit www.BrightGuard.com or call (310) 589-4116


Structured Label Content

Uses (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 43683-2 (43683-2)

Minor word changes in Administration such as apply liberally rather than apply generously

No Major changes in Uses section

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51945-4 (51945-4)

LABEL FOR IMPACT MELANOMA SPF

Section 69718-5 (69718-5)

IMPACT MELANOMA SPF 30

sunscreen is broad spectrum, water

resistant (80 minutes), free of parabens

and made for all skin types

Purpose

Octyl Methoxy Cinnamate 7.00% Sunscreen

Titanium Dioxide 1.25% Sunscreen

Zinc Oxide 1.25% Sunscreen

Octyl Salicylate 1.00% Sunscreen

Warnings (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 consult physician if irritation or rash develops.
  • Keep out of reach of children.
  • If product is swallowed, get medical attention or contact poison control center immediately.
Directions (DIRECTIONS)
  • Apply liberally 15 minutes before sun exposure
  • Reapply after 80 minutes of swimming or sweating.
  • reapply immediately after towel drying.
  • 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 sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including:
  • Limited time in the sun, especially between 10am and 2pm.
  • Wear long sleeve shirts, pants, hats and sunglasses.
  • For children under 6 months, consult a physician.
Other Ingredients (OTHER INGREDIENTS)

Aloe Barbadensis (Aloe Vera) Leaf Juice, Calendula Officinalis (Marigold) Flower Extract, Caprylyl Glycol, Carbopol, Ceteareth-20, Cetearyl Alcohol, Deionized Water, Dimethicone, Glycerin, Hexylene Glycol, Isocetyl Stearate, Malva Sylvestris (Mallow) Flower Extract, Panax Ginseng Root Extract, Phenoxyethanol, Polyester-7, Neopentyl Glycol, Diheptanoate, Sorbitol, Stearic Acid,

Symphytum Officinale (Comfrey) Leaf Extract, Triethanolamine, Tocopheryl Acetate (Vitamin E)

Other Information (Other information)
  • Protect this product from excessive heat and direct sunlight.
  • May stain some fabrics.
Active Ingredients

Octyl Methoxy Cinnamate 7.00% Sunscreen

Titanium Dioxide 1.25% Sunscreen

Zinc Oxide 1.25% Sunscreen

Octyl Salicylate 1.00% Sunscreen

Questions Or Comments? (Questions or Comments?)

Visit www.BrightGuard.com or call (310) 589-4116


Advanced Ingredient Data


Raw Label Data

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