Mula Maldives Spf-30 Non-aerosol Moisturizing Sunscreen Spray

Mula Maldives Spf-30 Non-aerosol Moisturizing Sunscreen Spray
SPL v1
SPL
SPL Set ID f9be092f-8d53-4bb2-8363-81c003da42d6
Route
TOPICAL
Published
Effective Date 2024-10-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Octisalate (50 mg) Octocrylene
Inactive Ingredients
Aloe Vera Leaf Ascorbic Acid Butyloctyl Salicylate Coconut Oil Green Tea Leaf Cucumber Helianthus Annuus Flowering Top Hydrogenated Methyl Abietate Flax Seed Cinidon-ethyl Sage .alpha.-tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-10-02

Description

Avobenzone 3.00% Octisalate 5.00% Octocrylene 5.00%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3.00% Octisalate 5.00% Octocrylene 5.00%

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 skin cancer and early skin aging caused by the sun.
Warnings

For external use only

Directions
  • Apply liberally 15 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.
  • Reapply:
  • after 80 minutes of swimming or sweating.
  • immediately after towel drying.
  • at least every 2 hours.
  • do not spray directly on face. Spray into hands and apply to face.
  • use in well ventilated areas

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 Ingredient

Avobenzone 3.00%

Octisalate 5.00%

Octocrylene 5.00%

Other Information
  • Protect the product in this container from excessive heat and direct sun.
Package Labelling:

Inactive Ingredients

Aloe Barbadensis Leaf (Aloe Vera) Extract, Ascorbyl Palmitate (Vitamin C), Butyloctyl Salicylate, Cocos Nucifera (Coconut) Oil, Camellia Sinensis (Green Tea) Extract, Cucumis Sativus (Cucumber) Extract, Helianthus Annuus (Sunflower) Oil, Hydrogenated Methyl Abietate, Linum Usitatissimum (Linseed) Oil, Nelumbo Nucifera (Lotus) Extract, Salvia Officinalis (Sage) Extract, SD-Alcohol 40B, Tocopheryl Acetate (Vitamin E).

Questions Or Comments ?
When Using This Product
  • Keep out of eyes. Rinse with water to remove.
  • Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120ºF.
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.


Structured Label Content

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 skin cancer and early skin aging caused by the sun.
Purpose

Sunscreen

Warnings

For external use only

Directions
  • Apply liberally 15 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.
  • Reapply:
  • after 80 minutes of swimming or sweating.
  • immediately after towel drying.
  • at least every 2 hours.
  • do not spray directly on face. Spray into hands and apply to face.
  • use in well ventilated areas

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 Ingredient

Avobenzone 3.00%

Octisalate 5.00%

Octocrylene 5.00%

Other Information
  • Protect the product in this container from excessive heat and direct sun.
Package Labelling:

Inactive Ingredients

Aloe Barbadensis Leaf (Aloe Vera) Extract, Ascorbyl Palmitate (Vitamin C), Butyloctyl Salicylate, Cocos Nucifera (Coconut) Oil, Camellia Sinensis (Green Tea) Extract, Cucumis Sativus (Cucumber) Extract, Helianthus Annuus (Sunflower) Oil, Hydrogenated Methyl Abietate, Linum Usitatissimum (Linseed) Oil, Nelumbo Nucifera (Lotus) Extract, Salvia Officinalis (Sage) Extract, SD-Alcohol 40B, Tocopheryl Acetate (Vitamin E).

Questions Or Comments ? (Questions or Comments ?)
When Using This Product (When using this product)
  • Keep out of eyes. Rinse with water to remove.
  • Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120ºF.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • Rash or irritation develops and lasts.
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.

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

ask a health professional before use.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)