zitsticka megashade sunscreen serum (spf-50)

zitsticka megashade sunscreen serum (spf-50)
SPL v3
SPL
SPL Set ID 32164318-7a7e-40b2-99da-8246c99fdbd3
Route
topical
Published
Effective Date 2021-08-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
homosalate (75 mg) octinoxate (50 mg) octisalate (30 mg) zinc cation
Inactive Ingredients
aloe vera leaf water butylene glycol butyloctyl salicylate alkyl (c12-15) benzoate green tea leaf medium-chain triglycerides carbomer homopolymer, unspecified type citric acid monohydrate watermelon ceramide ng cetostearyl alcohol cetearyl glucoside cocamidopropyl betaine oatmeal carrot dodecane ferulic acid glycerin glyceryl caprylate glyceryl stearate citrate glyceryl 1-undecylenate hyaluronic acid hydrogenated methyl abietate leuconostoc/radish root ferment filtrate melaleuca alternifolia leaf niacinamide palmitoyl tetrapeptide-7 palmitoyl tripeptide-1 palmitoyl lysyldioxymethionyllysine phenyl trimethicone polysorbate 20 kakadu plum thyme

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2021-04-10

Purpose

Sunscreen

Description

Homosalate 7.50% Octinoxate 7.50% Octisalate 5.00% Zinc Oxide 3.00%


Medication Information

Purpose

Sunscreen

Description

Homosalate 7.50% Octinoxate 7.50% Octisalate 5.00% Zinc Oxide 3.00%

Questions?

+1 (424) 274 4500

Uses:
  • Helps prevent sunburn.
  • Higher SPF gives more sunburn protection
  • 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
Warnings:

For external use only

Directions:

• Apply liberally 15 minutes before sun exposure • Children under 6 months of age: ask a doctor. • Reapply at least every 2 hours • Reapply as needed  • Use a water-resistant sunscreen if swimming or sweating • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the 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 from 10 a.m. - 2 p.m. • Wear long-sleeved shirts, pants, hats, and sunglasses.













Do Not Use:

On damaged or broken skin.

Active Ingredients

Homosalate 7.50% Octinoxate 7.50% Octisalate 5.00% Zinc Oxide 3.00%





Other Information:

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

Inactive Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butylene Glycol, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Camellia Sinensis (Green Teat) Extract, Caprylic/Capric Triglyceride, Carbomer, Citric Acid, Citrullus Lantus (Watermelon) Extract, Ceramide NG, Cetearyl Alcohol, Cetearyl Glucoside, Cocamidopropyl Betaine, Colloidal Oatmeal, Daucus Carota Sativa (Carrot) Extract, Dodecane, Ferulic Acid, Glycerin, Glyceryl Caprylate, Glyceryl Stearate Citrate, Glyceryl Undecylenate, Hyaluronic Acid, Hydrogenated Methyl Abietate, Hydropropyl Cyclodextrin, Leuconostoc/Radish Root Ferment Filtrate, Melaleuca Alternifolia (Tea Tree) Oil, Niacinamide, Palmitoyl Tetrapeptide-7, Palmitoyl Tripeptide-1, Palmitoyl Tripeptide-38, Phenyl Trimethicone, Polysorbate-20, Terminalia Ferdinandiana (Kakadu Plum) Oil, Thymus Vulgaris (Thyme) Extract.

When Using This Product:

Keep out of eyes. Rinse with water to remove

Package Labeling:81746 183 00

Package Labeling:81746 183 01

Stop Use and Ask A Doctor If:

Rash or irritation develops and lasts.

If Pregnant Or Breast Feeding,

ask a health professional before use

Keep Out of Reach of Children.

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


Structured Label Content

Purpose

Sunscreen

Questions?

+1 (424) 274 4500

Uses:
  • Helps prevent sunburn.
  • Higher SPF gives more sunburn protection
  • 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
Warnings:

For external use only

Directions:

• Apply liberally 15 minutes before sun exposure • Children under 6 months of age: ask a doctor. • Reapply at least every 2 hours • Reapply as needed  • Use a water-resistant sunscreen if swimming or sweating • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the 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 from 10 a.m. - 2 p.m. • Wear long-sleeved shirts, pants, hats, and sunglasses.













Do Not Use: (Do not use:)

On damaged or broken skin.

Active Ingredients

Homosalate 7.50% Octinoxate 7.50% Octisalate 5.00% Zinc Oxide 3.00%





Other Information:

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

Inactive Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butylene Glycol, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Camellia Sinensis (Green Teat) Extract, Caprylic/Capric Triglyceride, Carbomer, Citric Acid, Citrullus Lantus (Watermelon) Extract, Ceramide NG, Cetearyl Alcohol, Cetearyl Glucoside, Cocamidopropyl Betaine, Colloidal Oatmeal, Daucus Carota Sativa (Carrot) Extract, Dodecane, Ferulic Acid, Glycerin, Glyceryl Caprylate, Glyceryl Stearate Citrate, Glyceryl Undecylenate, Hyaluronic Acid, Hydrogenated Methyl Abietate, Hydropropyl Cyclodextrin, Leuconostoc/Radish Root Ferment Filtrate, Melaleuca Alternifolia (Tea Tree) Oil, Niacinamide, Palmitoyl Tetrapeptide-7, Palmitoyl Tripeptide-1, Palmitoyl Tripeptide-38, Phenyl Trimethicone, Polysorbate-20, Terminalia Ferdinandiana (Kakadu Plum) Oil, Thymus Vulgaris (Thyme) Extract.

When Using This Product: (When using this product:)

Keep out of eyes. Rinse with water to remove

Package Labeling:81746 183 00 (Package Labeling:81746-183-00)

Package Labeling:81746 183 01 (Package Labeling:81746-183-01)

Stop Use and Ask A Doctor If: (Stop use and ask a doctor if:)

Rash or irritation develops and lasts.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use

Keep Out of Reach of Children. (Keep out of reach of children.)

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


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