Sunstation Usa Spf-30 Sport Sunscreen

Sunstation Usa Spf-30 Sport Sunscreen
SPL v2
SPL
SPL Set ID 11d3c60e-238d-999e-e063-6394a90a624b
Route
TOPICAL
Published
Effective Date 2024-02-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (63 g) Octisalate (9 g) Titanium Dioxide (11.2 g) Zinc Oxide
Inactive Ingredients
Cetostearyl Alcohol Dimethicone 350 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 Asian Ginseng Malva Sylvestris Flower Glycerin Cetyl Alcohol Matricaria Recutita Flowering Top Comfrey Leaf Sorbitol Polyoxyl 20 Cetostearyl Ether

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-02-20

Description

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

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

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

Uses
  • Helps prevent sunburn.
  • higher SPF gives more sunburn protection
  • retains SPF after 80 minutes of swimming or sweating
  • If used as directed with other sun protection measures (see Directions), decreases the risk of cancer and early skin aging caused by the sun.

Section 43683-2
  • added more descriptive text. No major change.
  • Changes to Directions are not major - just a reordering of phrases.
Section 50565-1

Keep out of reach of children.

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

Section 53413-1

QUESTIONS ?

816-686-1345

Section 60561-8

Protect the product in this container from excessive heat and direct sun

Section 69718-5

SUNSTATION USA®

SPF-30 SPORT SUNSCREEN

OXYBENZONE & PARABEN FREE

UVA/UVB PROTECTION SUNSCREEN

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 if rash or irritation develops and lasts
  • Keep out of reach of children.
  • If swallowed, get medical help, or contact a Poison Control Center right away.
  • If pregnant or breast-feeding, ask a health professional before use.
Directions
  • Apply liberally 15 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.
  • After 80 minutes of swimming or sweating.
  • Immediately after towel drying.
  • 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 broad spectrum SPF of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially between 10am and 2pm.
  • Wear long sleeve shirts, pants, hats and sunglasses.
Other Ingredients

Aloe Barbadensis (Aloe Vera) Leaf Juice, Calendula Officinalis (Marigold) Flower Extract, Caprylyl Glycol, 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)

Active Ingredients

Octyl Methoxy Cinnamate 7.00% Sunscreen

Titanium Dioxide 1.25% Sunscreen

Zinc Oxide 1.25% Sunscreen

Octyl Salicylate 1.00% Sunscreen

Sunstation Product Label


Structured Label Content

Uses (USES)
  • Helps prevent sunburn.
  • higher SPF gives more sunburn protection
  • retains SPF after 80 minutes of swimming or sweating
  • If used as directed with other sun protection measures (see Directions), decreases the risk of cancer and early skin aging caused by the sun.

Section 43683-2 (43683-2)
  • added more descriptive text. No major change.
  • Changes to Directions are not major - just a reordering of phrases.
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 53413-1 (53413-1)

QUESTIONS ?

816-686-1345

Section 60561-8 (60561-8)

Protect the product in this container from excessive heat and direct sun

Section 69718-5 (69718-5)

SUNSTATION USA®

SPF-30 SPORT SUNSCREEN

OXYBENZONE & PARABEN FREE

UVA/UVB PROTECTION SUNSCREEN

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 ask a doctor if rash or irritation develops and lasts
  • Keep out of reach of children.
  • If swallowed, get medical help, or contact a Poison Control Center right away.
  • If pregnant or breast-feeding, ask a health professional before use.
Directions (DIRECTIONS)
  • Apply liberally 15 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.
  • After 80 minutes of swimming or sweating.
  • Immediately after towel drying.
  • 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 broad spectrum SPF of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially between 10am and 2pm.
  • Wear long sleeve shirts, pants, hats and sunglasses.
Other Ingredients (OTHER INGREDIENTS)

Aloe Barbadensis (Aloe Vera) Leaf Juice, Calendula Officinalis (Marigold) Flower Extract, Caprylyl Glycol, 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)

Active Ingredients

Octyl Methoxy Cinnamate 7.00% Sunscreen

Titanium Dioxide 1.25% Sunscreen

Zinc Oxide 1.25% Sunscreen

Octyl Salicylate 1.00% Sunscreen

Sunstation Product Label (SUNSTATION PRODUCT LABEL)


Advanced Ingredient Data


Raw Label Data

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