FDA.reportPublic FDA data

To Save Face SPF 30 Plus

Manufacturer
Mecca Brands Pty Ltd | Delta Laboratories Pty Limited
Effective date
2014-12-29
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 22:41:19

Label at a glance#

ProductTo Save Face SPF 30 Plus Facial Sunscreen
Active ingredientAVOBENZONE, OXYBENZONE, ENSULIZOLE, OCTOCRYLENE
Label structure13 sections

Indications and 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

Dosage and administration

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...

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

Warnings

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • 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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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)


Front CartonFront Carton

Back CartonBack Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69505-001-012020-01-31C16284748780-19d75b9d0-2cf2-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69505-001-01To Save Face SPF 30 PlusFacial Sunscreen1 in 1 CARTONCREAM14
69505-001-01To Save Face SPF 30 PlusFacial Sunscreen100 g in 1 TUBECREAM1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69505-001TO SAVE FACE SPF 30 PLUS FACIAL SUNSCREEN (AVOBENZONE, OCTOCRYLENE, OXYBENZONE, PHENYLBENZIMIDAZOLE SULFONIC ACID ) CREAM [MECCA BRANDS PTY LTD ]4Legacy NDC, 2 package rows20150109_d8c24bfa-6792-4155-ac28-6afe8f76f6cb.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX4
ENSULIZOLEACTIVE INGREDIENT9YQ9DI1W424
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WM4
OXYBENZONEACTIVE INGREDIENT95OOS7VE0Y4
AVOBENZONEACTIVE MOIETYG63QQF2NOX4
ENSULIZOLEACTIVE MOIETY9YQ9DI1W424
OCTOCRYLENEACTIVE MOIETY5A68WGF6WM4
OXYBENZONEACTIVE MOIETY95OOS7VE0Y4
HYALURONIC ACIDINACTIVE INGREDIENTS270N0TRQY4
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T4
POMEGRANATEINACTIVE INGREDIENT56687D1Z4D4
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P84

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69505-00169505-001-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
OXYBENZONE95OOS7VE0YACTIB
ENSULIZOLE9YQ9DI1W42ACTIB
OCTOCRYLENE5A68WGF6WMACTIB
HYALURONIC ACIDS270N0TRQYIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POMEGRANATE56687D1Z4DIACT
TOCOPHEROLR0ZB2556P8IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 11 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii candidate
6 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8CAPSULE, COATED / ORAL0.25 mgExact identifier — unii candidate
5 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8CREAM / TOPICALNAExact identifier — unii candidate
5 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8TABLET / ORAL0.08 mgExact identifier — unii candidate
5 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL, FOAM / TOPICAL72 mgExact identifier — unii candidate
6 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii candidate
6 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL / TOPICAL1.05 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8CAPSULE / ORALNAExact identifier — unii candidate
5 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM, AUGMENTED / TOPICAL10 mgExact identifier — unii candidate
6 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8INJECTION, EMULSION / INTRAVENOUS0.02 %w/vExact identifier — unii candidate
5 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
c0cfb8e0-d58c-4980-a63e-179f91337004d8c24bfa-6792-4155-ac28-6afe8f76f6cb2014-12-29WarningsExact identifier
spl id: c0cfb8e0-d58c-4980-a63e-179f91337004
spl set id: d8c24bfa-6792-4155-ac28-6afe8f76f6cb

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.