SPL v1
SPL
SPL Set ID 39035b99-e560-e6b6-e063-6294a90a19c6
Route
CUTANEOUS
Published
Effective Date 2025-07-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (7.5 g) Octinoxate
Inactive Ingredients
Butylene Glycol Dicaprylate/dicaprate C12-15 Alkyl Benzoate Caprylic/capric Triglyceride Citric Acid Cocamidopropyl Betaine Ferulic Acid Glyceryl Caprylate Glyceryl Stearate Hyaluronic Acid Leuconostoc/radish Root Ferment Filtrate Melaleuca Alternifolia (tea Tree) Leaf Palmitoyl Tetrapeptide-7 Zinc Oxide Thymus Vulgaris (thyme) Oil Aloe Barbadensis Leaf Juice Carbomer Glycerin Palmitoyl Tripeptide-38 Aqua Pentamethyl Cyclopentasiloxane Daucus Carota Sativa (carrot) Seed Oil Hydrogenated Methyl Abietate Citrullus Lanatus (watermelon) Seed Oil Ceramide Ng Butyloctyl Salicylate Camellia Sinensis Leaf Niacinamide Octisalate Amodimethicone (1300 Cst) Palmitoyl Tripeptide-1

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2025-07-03

Description

1.69 FL.OZ/50 ML


Medication Information

Warnings and Precautions

Please put it in a place where children are not in contact

Indications and Usage

Sunscreen

Dosage and Administration

1.69 FL.OZ/50 ML

Description

1.69 FL.OZ/50 ML

Section 50565-1

KEEP OUT OF REACH OF CHILDREN SECTION

Section 51727-6

Octisalate,Zinc Oxide,Aloe Barbadensis Leaf (Aloe Vera Gel) Juice,Amodimethicone,Aqua (Deionized Water),Butylene Glycol

Butyloctyl Salicylate,C12-15 Alkyl Benzoate,Camellia Sinensis (Green Teat) Extract,Caprylic/Capric Triglyceride

Carbomer,Citric Acid,Citrullus Lanatus (Watermelon) Extract,Ceramide NG,Cocamidopropyl Betaine,Colloidal Oatmeal

Cyclopentasiloxane,Daucus Carota Sativa (Carrot) Extract,Ferulic Acid, Glycerin,Glyceryl Caprylate,Glyceryl Stearate,

Glyceryl Undecylenate,Hyaluronic Acid,Hydrogenated Methyl Abietate,Hydroxypropyl Cyclodextrin

Leuconostoc/Radish Root Ferment Filtrate,Melaleuca Alternifolia (Tea Tree) Oil,Niacinamide

Palmitoyl Tetrapeptide-7,Palmitoyl Tripeptide-1

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Homosalate,Octinoxate


Structured Label Content

Indications and Usage (34067-9)

Sunscreen

Dosage and Administration (34068-7)

1.69 FL.OZ/50 ML

Warnings and Precautions (34071-1)

Please put it in a place where children are not in contact

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN SECTION

Section 51727-6 (51727-6)

Octisalate,Zinc Oxide,Aloe Barbadensis Leaf (Aloe Vera Gel) Juice,Amodimethicone,Aqua (Deionized Water),Butylene Glycol

Butyloctyl Salicylate,C12-15 Alkyl Benzoate,Camellia Sinensis (Green Teat) Extract,Caprylic/Capric Triglyceride

Carbomer,Citric Acid,Citrullus Lanatus (Watermelon) Extract,Ceramide NG,Cocamidopropyl Betaine,Colloidal Oatmeal

Cyclopentasiloxane,Daucus Carota Sativa (Carrot) Extract,Ferulic Acid, Glycerin,Glyceryl Caprylate,Glyceryl Stearate,

Glyceryl Undecylenate,Hyaluronic Acid,Hydrogenated Methyl Abietate,Hydroxypropyl Cyclodextrin

Leuconostoc/Radish Root Ferment Filtrate,Melaleuca Alternifolia (Tea Tree) Oil,Niacinamide

Palmitoyl Tetrapeptide-7,Palmitoyl Tripeptide-1

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Homosalate,Octinoxate


Advanced Ingredient Data


Raw Label Data

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