Active Ingredients And Purpose
OTC - ACTIVE INGREDIENT
Active Ingredient: Octinoxate 4.0% w/w.
OTC - PURPOSE
SPF 8 provides sun protection.
Flawless Finish Bare Perfection Makeup SPF 8 Camellia
- Manufacturer
- Elizabeth Arden, Inc
- Effective date
- 2011-05-06
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:28:57
Key Label Information#
Uses
INDICATIONS AND USAGE
To Use: Smooth on to face before sun exposure.
Warnings
WARNINGS
Warning: For external use only. Keep out of eyes.Stop use and see a doctor is rash or irritation develops and lasts. Keep out of reach of children.
Directions And Dosage
DOSAGE & ADMINISTRATION
Smooth on to face.
Other Label Information
INACTIVE INGREDIENT
Other Ingredients: Water/Aqua/Eau, Isostearyl Palmitate, C12-15 Alkyl Benzoate, Butylene Glycol, Dimethicone, Oleic Acid, Glycerin, C12-20 Acid PEG-8 Ester, Polysorbate 40, Triethanolamine, Magnesium Aluminum Silicate, Dimethicone Copolyol, Phenyl Trimethicone, Sodium Hyaluronate, Retinyl Linoleate, Tocopherol, Glyceryl Stearate SE, Sucrose Laurate, Trehalose, Lecithin, Phospholipids, Tridecyl Salicylate, Decyl Glucoside, PEG-40 Stearate, Sorbitan Palmitate, Sorbitan Stearate, Behenyl Alcohol, Carbomer, Xanthan Gum, Disodium EDTA, Kaolin, Silica, Cyclopentasiloxane, Dimethiconol, Parfum/Fragrance, Butylphenyl Methylpropional, Hydroxycitronellal, Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde, Limonene, Butylparaben, Ethylparaben, Isobutylparaben, Methylparaben, Phenoxyethanol, Propylparaben, Iron Oxides (CI77491, CI 77492, CI 77499), Titanium Dioxide (CI 77891).
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Label Images#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 67938-0834-1 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-cc9e-8e05-e053-dbdaa90a074a | BC0834 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67938-0834-1 | Flawless Finish Bare Perfection Makeup SPF 8 Camellia | 1 in 1 BOX | LOTION | 1 | 1 | |
| 67938-0834-2 | Flawless Finish Bare Perfection Makeup SPF 8 Camellia | 30 mL in 1 BOTTLE, PUMP | LOTION | 30 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 67938-0834 | FLAWLESS FINISH BARE PERFECTION MAKEUP SPF 8 CAMELLIA (OCTINOXATE) LOTION [ELIZABETH ARDEN, INC] | 1 | Legacy NDC, 2 package rows | 20110726_fd31f1a4-24d7-45cd-ab7f-e2f133fd1c87.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| OCTINOXATE | ACTIVE INGREDIENT | 4Y5P7MUD51 | 1 | |
| OCTINOXATE | ACTIVE MOIETY | 4Y5P7MUD51 | 1 | |
| ALKYL (C12-15) BENZOATE | INACTIVE INGREDIENT | A9EJ3J61HQ | 1 | |
| BUTYLENE GLYCOL | INACTIVE INGREDIENT | 3XUS85K0RA | 1 | |
| DICAPRYLYL CARBONATE | INACTIVE INGREDIENT | 609A3V1SUA | 1 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | 1 | |
| DOCOSANOL | INACTIVE INGREDIENT | 9G1OE216XY | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| GLYCERYL MONOSTEARATE | INACTIVE INGREDIENT | 230OU9XXE4 | 1 | |
| KAOLIN | INACTIVE INGREDIENT | 24H4NWX5CO | 1 | |
| MAGNESIUM ALUMINUM SILICATE | INACTIVE INGREDIENT | 6M3P64V0NC | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 1 | |
| OLEIC ACID | INACTIVE INGREDIENT | 2UMI9U37CP | 1 | |
| PHENOXYETHANOL | INACTIVE INGREDIENT | HIE492ZZ3T | 1 | |
| PHENYL TRIMETHICONE | INACTIVE INGREDIENT | DR0K5NOJ4R | 1 | |
| POLYSORBATE 40 | INACTIVE INGREDIENT | STI11B5A2X | 1 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 1 | |
| SORBITAN MONOPALMITATE | INACTIVE INGREDIENT | 77K6Z421KU | 1 | |
| SUCROSE LAURATE | INACTIVE INGREDIENT | 05Q7CD0E49 | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| TROLAMINE | INACTIVE INGREDIENT | 9O3K93S3TK | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | 1 |
Products#
- Flawless Finish Bare Perfection Makeup SPF 8 Camellia
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 67938-0834 | 67938-0834-2, 67938-0834-1 |
Ingredients#
Complete SPL Sections#
DESCRIPTION
For normal skin. Medium coverage. Natural finish. This oil free liquid makeup gives skin a firmer look and reflects light to soften fine lines. SPF 8 provides sun protection. Clinically, dermatologist and allergy tested.
INDICATIONS AND USAGE
To Use: Smooth on to face before sun exposure.
WARNINGS
Warning: For external use only. Keep out of eyes.Stop use and see a doctor is rash or irritation develops and lasts. Keep out of reach of children.
OTC - ACTIVE INGREDIENT
Active Ingredient: Octinoxate 4.0% w/w.
INACTIVE INGREDIENT
Other Ingredients: Water/Aqua/Eau, Isostearyl Palmitate, C12-15 Alkyl Benzoate, Butylene Glycol, Dimethicone, Oleic Acid, Glycerin, C12-20 Acid PEG-8 Ester, Polysorbate 40, Triethanolamine, Magnesium Aluminum Silicate, Dimethicone Copolyol, Phenyl Trimethicone, Sodium Hyaluronate, Retinyl Linoleate, Tocopherol, Glyceryl Stearate SE, Sucrose Laurate, Trehalose, Lecithin, Phospholipids, Tridecyl Salicylate, Decyl Glucoside, PEG-40 Stearate, Sorbitan Palmitate, Sorbitan Stearate, Behenyl Alcohol, Carbomer, Xanthan Gum, Disodium EDTA, Kaolin, Silica, Cyclopentasiloxane, Dimethiconol, Parfum/Fragrance, Butylphenyl Methylpropional, Hydroxycitronellal, Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde, Limonene, Butylparaben, Ethylparaben, Isobutylparaben, Methylparaben, Phenoxyethanol, Propylparaben, Iron Oxides (CI77491, CI 77492, CI 77499), Titanium Dioxide (CI 77891).
DOSAGE & ADMINISTRATION
Smooth on to face.
OTC - KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children.
OTC - PURPOSE
SPF 8 provides sun protection.
OTC - WHEN USING
Keep out of eyes.