Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID d8c24bfa-6792-4155-ac28-6afe8f76f6cb
Route
TOPICAL
Published
Effective Date 2014-12-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (1 g) Oxybenzone (1.5 g) Ensulizole (2 g) Octocrylene (5 g)
Inactive Ingredients
Hyaluronic Acid Phenoxyethanol Pomegranate Tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-12-29

Description

Avobenzone 1%, Octocrylene 5%, Oxybenzone 1.5%, Phenylbenzimidazole sulfonic 2%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 1%, Octocrylene 5%, Oxybenzone 1.5%, Phenylbenzimidazole sulfonic 2%

Uses
  • Helps prevent sunburn
  • Higher SPF gives more sun 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

Section 50565-1

Keep out of reach of children.  If swallowed get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if rash or irritation develops and lasts.

Section 50567-7

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

Section 50570-1

Do not use on damaged or broken skin

Section 51945-4

SUN SERIES



TO SAVE FACE

SPF30+ FACIAL SUNSCREEN



MECCA COSMETICA

WEIGHTLESS HYDRATING FORMULA

UVA and UVB PROTECTION

PERFECT MAKEUP BASE

NET WT 3.53 OZ. (100G)



Warnings

Skin Cancer/Skin Aging Alert:  Spending time in the sun increases your risk of skin cancer and early skin aging.  This product has been shown to help only prevent sunburn, not skin cancer or early skin aging.

For external use only

Directions
  • Apply liberally and evenly to face and neck 15 minutes before sun exposure and as needed
  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating
  • Reapply as needed or after towel drying, swimming, or sweating
  • May be worn alone or under makeup
  • 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 value of 15 or higher and other sun protection measures including:
    • Limit time in sun, especially from 10am-2pm
    • Wear long-sleeve shirts, pants, hats and sunglasses
  • Children under 6 months of age: ask a doctor

Other Information
  • Sun alert:  Limiting sun exposure, wearing protective clothing and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.
  • Protect this product from excessive heat an direct sun
  • Store below 30 degrees C/86 degrees F

Active Ingredients

Avobenzone 1%, Octocrylene 5%, Oxybenzone 1.5%, Phenylbenzimidazole sulfonic 2%

Inactive Ingredients

Hyaluronic acid, Parabens, Phenoxyethanol, Punica granatum (Pomegranate) Fruit Extract, Tocopherol (Vitamin E)

Questions Or Comments?

In Australia at www.mecca.com.au

In the USA at J Crew customer relations 24 hours, 7 days a week at +1 434 385 5575


Structured Label Content

Uses
  • Helps prevent sunburn
  • Higher SPF gives more sun 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

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 50566-9 (50566-9)

Stop use and ask a doctor if rash or irritation develops and lasts.

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Section 51945-4 (51945-4)

SUN SERIES



TO SAVE FACE

SPF30+ FACIAL SUNSCREEN



MECCA COSMETICA

WEIGHTLESS HYDRATING FORMULA

UVA and UVB PROTECTION

PERFECT MAKEUP BASE

NET WT 3.53 OZ. (100G)



Purpose

Sunscreen

Warnings

Skin Cancer/Skin Aging Alert:  Spending time in the sun increases your risk of skin cancer and early skin aging.  This product has been shown to help only prevent sunburn, not skin cancer or early skin aging.

For external use only

Directions
  • Apply liberally and evenly to face and neck 15 minutes before sun exposure and as needed
  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating
  • Reapply as needed or after towel drying, swimming, or sweating
  • May be worn alone or under makeup
  • 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 value of 15 or higher and other sun protection measures including:
    • Limit time in sun, especially from 10am-2pm
    • Wear long-sleeve shirts, pants, hats and sunglasses
  • Children under 6 months of age: ask a doctor

Other Information
  • Sun alert:  Limiting sun exposure, wearing protective clothing and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.
  • Protect this product from excessive heat an direct sun
  • Store below 30 degrees C/86 degrees F

Active Ingredients

Avobenzone 1%, Octocrylene 5%, Oxybenzone 1.5%, Phenylbenzimidazole sulfonic 2%

Inactive Ingredients

Hyaluronic acid, Parabens, Phenoxyethanol, Punica granatum (Pomegranate) Fruit Extract, Tocopherol (Vitamin E)

Questions Or Comments? (Questions or comments?)

In Australia at www.mecca.com.au

In the USA at J Crew customer relations 24 hours, 7 days a week at +1 434 385 5575


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)