smashbox

smashbox
SPL v1
SPL
SPL Set ID afb9b34d-3107-45e2-ba68-9a991c09e622
Route
topical
Published
Effective Date 2012-01-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octinoxate (7.5 mL) octisalate (5 mL)
Inactive Ingredients
cyclomethicone 5 diethylamino hydroxybenzoyl hexyl benzoate safflower oil cola acuminata seed camellia oleifera leaf vitis vinifera seed alkyl (c12-15) benzoate tribehenin ceramide 2 peg-10 rapeseed sterol palmitoyl oligopeptide alpha-tocopherol acetate vitamin a palmitate water silicon dioxide hexylene glycol propylene glycol triethoxycaprylylsilane caprylyl glycol ethylhexylglycerin phenoxyethanol ferric oxide red titanium dioxide

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2011-10-01

Description

Apply evenly to face prior to sun exposure. Children under 6 months of age: ask doctor.


Medication Information

Warnings

For external use only.

Directions

Apply evenly to face prior to sun exposure. Children under 6 months of age: ask doctor.

Inactive Ingredients

Cyclopentasiloxane, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Ethyl Perfluoroisobutyl Ether, Ethyl Perfluorobutyl Ether, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Carthamus Tinctorius (Safflower) Seed Oil, Cola Acuminata Seed Extract, Camellia Oleifera Leaf Extract, Vitis Vinifera (Grape) Seed Extract, C12-15 Alkyl Benzoate, Tribehenin, Ceramide 2, PEG-10 Rapeseed Sterol, Palmitoyl Oligopeptide, Tocophenyl Acetate, Retinyl Palmitate, Water/Aqua/Eau, Ethyl Trisiloxane, Caprylyl Methicone, Methicone, Silica, Silica Silylate, Hexylene Glycol, Propylene Glycol, Triethoxycaprylylsilane, Caprylyl Glycol, Ethylhexylglycerin, Phenoxyethanol [+/- Iron Oxides (CI77491), Titanium Dioxide (CI77891)].

Description

Apply evenly to face prior to sun exposure. Children under 6 months of age: ask doctor.

Section 42229-5

Apply before sun exposure.

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop using if irritation occurs.

Section 50567-7

When using this product

Keep out of eyes. Rinse with water to remove.

Section 50569-3

If irritation persists, consult a health care practitioner.

Section 55105-1

Drug Facts

Warning

Keep out of eyes.

Sun Alert

The sun may cause sunburn, premature aging of skin and skin cancer. Avoiding the sun, wearing protective clothing and regular use of sunscreens over the years may reduce the chance of these harmful effects.

Active Ingredients

7.5% Octinoxate, 5.0% Octisalate.

Stop Use and Ask A Doctor If

Rash or irritation develops and lasts.

Principal Display Panel 30 Ml Tube Carton

smashbox

PHOTO FINISH

SPF 15

WITH DERMAXYL™ COMPLEX

FOUNDATION PRIMER

SPF 15 ET DERMAXYL™

1 fl. oz./30ml e


Structured Label Content

Warnings

For external use only.

Directions

Apply evenly to face prior to sun exposure. Children under 6 months of age: ask doctor.

Inactive Ingredients (INACTIVE INGREDIENTS)

Cyclopentasiloxane, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Ethyl Perfluoroisobutyl Ether, Ethyl Perfluorobutyl Ether, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Carthamus Tinctorius (Safflower) Seed Oil, Cola Acuminata Seed Extract, Camellia Oleifera Leaf Extract, Vitis Vinifera (Grape) Seed Extract, C12-15 Alkyl Benzoate, Tribehenin, Ceramide 2, PEG-10 Rapeseed Sterol, Palmitoyl Oligopeptide, Tocophenyl Acetate, Retinyl Palmitate, Water/Aqua/Eau, Ethyl Trisiloxane, Caprylyl Methicone, Methicone, Silica, Silica Silylate, Hexylene Glycol, Propylene Glycol, Triethoxycaprylylsilane, Caprylyl Glycol, Ethylhexylglycerin, Phenoxyethanol [+/- Iron Oxides (CI77491), Titanium Dioxide (CI77891)].

Section 42229-5 (42229-5)

Apply before sun exposure.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop using if irritation occurs.

Section 50567-7 (50567-7)

When using this product

Keep out of eyes. Rinse with water to remove.

Section 50569-3 (50569-3)

If irritation persists, consult a health care practitioner.

Section 55105-1 (55105-1)

Drug Facts

Warning (WARNING)

Keep out of eyes.

Sun Alert

The sun may cause sunburn, premature aging of skin and skin cancer. Avoiding the sun, wearing protective clothing and regular use of sunscreens over the years may reduce the chance of these harmful effects.

Active Ingredients (ACTIVE INGREDIENTS)

7.5% Octinoxate, 5.0% Octisalate.

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

Rash or irritation develops and lasts.

Principal Display Panel 30 Ml Tube Carton (PRINCIPAL DISPLAY PANEL - 30 ml Tube Carton)

smashbox

PHOTO FINISH

SPF 15

WITH DERMAXYL™ COMPLEX

FOUNDATION PRIMER

SPF 15 ET DERMAXYL™

1 fl. oz./30ml e


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)