FDA.reportPublic FDA data

Extreme (UVA/UVB) SPF 33

Manufacturer
Anna Lotan Ltd.
Effective date
2019-08-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:13:59

Label at a glance#

ProductExtreme (UVA/UVB) SPF 33
Active ingredientOCTINOXATE, AVOBENZONE, OCTOCRYLENE
Label structure7 sections

Indications and uses

● Helps to prevent sunburn ● If used as directed with other sun protective measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and administration

● Apply liberally 15 minutes before sun exposure. ● Reapply:      • after 40 minutes of swimming or sweating      • immediately after towel drying      • at least every 2 hours ● 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 of 15 or higher and other protection measures including:...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethylhexyl Methoxycinnamate 7.50%

Butyl Methoxydibenzoylmethane 3.00%

Octocrylene 2.80%

Purpose:

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

● Helps to prevent sunburn
● If used as directed with other sun protective measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

if rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

● Apply liberally 15 minutes before sun exposure.
● Reapply:
     • after 40 minutes of swimming or sweating
     • immediately after towel drying
     • at least every 2 hours
● 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 of 15 or higher and other protection measures including:
• Limit time in sun from 10 am - 2 pm.
• Wear long-sleeve shirts, pants, hats and sunglasses.
● Children under 6 months: Ask a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua (Water), C12-15 Alkyl Benzoate, Sorbitol, Alcohol, Ethylhexyl Methoxycrylene, Commiphora Myrrha Resin Extract, Cetyl Phosphate, Glyceryl Stearate, Glycerin, Simmondsia Chinensis (Jojoba) Seed Oil, Polygonum Aviculare Extract, Titanium Dioxide, PEG-100 Stearate, Mica, Phenoxyethanol, Lonicera Caprifolium (Honeysuckle) Extract, Aloe Barbadensis Leaf Juice Powder, Sodium Polyacrylate, Leontopodium Alpinum Extract, Squalane, Dunaliella Salina Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Parfum (Fragrance), Tocopherol, Silica, Xanthan Gum, Beta-Sitosterol, Squalene, Ethylhexylglycerin, Sodium Hydroxide, Disodium EDTA.

Questions or Comments?

OTC - QUESTIONS SECTION

Contact: info@annalotan-usa.com

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76446-00876446-008-75

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
SORBITOL506T60A25RIACT
ALCOHOL3K9958V90MIACT
ETHYLHEXYL METHOXYCRYLENES3KFG6Q5X8IACT
MYRRHJC71GJ1F3LIACT
CETYL PHOSPHATEVT07D6X67OIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
GLYCERINPDC6A3C0OXIACT
JOJOBA OIL724GKU717MIACT
POLYGONUM AVICULARE TOPZCD6009IUFIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
PEG-100 STEARATEYD01N1999RIACT
MICAV8A1AW0880IACT
PHENOXYETHANOLHIE492ZZ3TIACT
LONICERA CAPRIFOLIUM FLOWER5N1WD9784UIACT
ALOE VERA LEAFZY81Z83H0XIACT
SQUALANEGW89575KF9IACT
DUNALIELLA SALINAF4O1DKI9A6IACT
LONICERA JAPONICA FLOWER4465L2WS4YIACT
TOCOPHEROLR0ZB2556P8IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
XANTHAN GUMTTV12P4NEEIACT
.BETA.-SITOSTEROLS347WMO6M4IACT
SQUALENE7QWM220FJHIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
SODIUM HYDROXIDE55X04QC32IIACT
EDETATE DISODIUM7FLD91C86KIACT
OCTINOXATE4Y5P7MUD51ACTIB
AVOBENZONEG63QQF2NOXACTIB
OCTOCRYLENE5A68WGF6WMACTIB

Source Document#

Source XML

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
9141a61f-4dec-0192-e053-2995a90a9a3d3e7a8cd1-61cf-4555-bbb9-8d153dbb0c972019-08-29WarningsExact identifier
spl id: 9141a61f-4dec-0192-e053-2995a90a9a3d
spl set id: 3e7a8cd1-61cf-4555-bbb9-8d153dbb0c97

Reported adverse events (FAERS/openFDA)#

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